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									                                                                                      CMDh CONTACT POINTS
                                                           For all contact points for a specific country, please select the country on the filter arrow in the "country" column.
                 For contact poins for a specific procedure i.e. Advice on MRP/DCP procedures, Submission of translations in MRP/DCP etc. select the procedure on the filter arrow in the "Type of contact" column.

COUNTRY                  TYPE OF CONTACT                                       ADDRESS                                CONTACT                        E-MAIL                    PHONE NR              FAX NR

                                                               Austrian Medicines and Medical Devices Agency
                                                                                                               Christa WIRTHUMER-HOCHE    christa.wirthumer-hoche@ages.at   00 43 5 0555 36500   00 43 5 0555 36508
                                                                               Traisengasse 5
AUSTRIA             Advice on MRP/DCP procedures                                                                  Ingeborg GERNGROSS        ingeborg.gerngross@ages.at      00 43 5 0555 36611   00 43 5 0555 36629
                                                                               A-1200 VIENNA
                                                                                                                       Kristof LISZKA           kristof.liszka@ages.at      00 43 5 0555 36610   00 43 5 0555 36629
                                                                                   Austria




                                                               Austrian Medicines and Medical Devices Agency
              Submission of new applications, variations and                   Traisengasse 5
AUSTRIA
                               renewals                                        A-1200 VIENNA
                                                                                   Austria



                                                                                                                     MA applications
                                                               Austrian Medicines and Medical Devices Agency
              Submission of electronic response documents                      Traisengasse 5
AUSTRIA                                                                                                                Variations               responses@ages.at
                     during MRP/DCP procedures                                 A-1200 VIENNA
                                                                                   Austria
                                                                                                                       Renewals

                                                               Austrian Medicines and Medical Devices Agency
                 Submission of translations in MRP/DCP                         Traisengasse 5
AUSTRIA                                                                                                                Variations                mrp-spc@ages.at
                              procedures                                       A-1200 VIENNA
                                                                                   Austria



                                                               Austrian Medicines and Medical Devices Agency
                 Submission of electronic versions of the
                                                                               Traisengasse 5
AUSTRIA           responses to the list of questions for                                                                                    ingeborg.gerngross@ages.at
                                                                               A-1200 VIENNA
                   applications referred to the CMDh
                                                                                   Austria



                                                               Austrian Medicines and Medical Devices Agency
                 Contact points for requests for variation                     Traisengasse 5
AUSTRIA                                                                                                                                    hotline.euregulatory@ages.at
                           grouping numbers                                    A-1200 VIENNA
                                                                                   Austria



                                                               Austrian Medicines and Medical Devices Agency
                 Submission of paediatric information in                       Traisengasse 5
AUSTRIA                                                                                                                                     kinderarzneimittel@ages.at
                  member states - Articles 45 and 46                           A-1200 VIENNA
                                                                                   Austria



                                                               Austrian Medicines and Medical Devices Agency
                                                                               Traisengasse 5
AUSTRIA                Address for advice on fees                                                                                          hotline.euregulatory@ages.at
                                                                               A-1200 VIENNA
                                                                                   Austria




CMDh Compiled Contact Points                                                                             CMDh/245/2011, Rev5, June 2012
                                                                          UniCredit Bank AustriaAG
                                                                       Konto Nummer: 50670 871 619
AUSTRIA                      Fees payable to                                    BLZ: 12000
                                                                       IBAN: AT971200050670871619
                                                                          BIC/SWIFT: BKAUATWW




                                                               Federal Agency for Medicines and Health Products
                                                                                 Eurostation II
                                                                            Place Victor Horta, 40
BELGIUM             Advice on MRP/DCP procedures                                                                          Sophie Colyn                 sophie.colyn@fagg.be       00 32 2 524 8087
                                                                                   Boite 40
                                                                               B-1060 Brussels
                                                                                   Belgium




                                                               Federal Agency for Medicines and Health Products
                                                                                                                                                                                  00 32 2 524 8087
                                                                                 Eurostation II                   MA applications: Sophie Colyn
              Submission of new applications, variations and                Place Victor Horta, 40
BELGIUM                                                                                                                                             dispatching@fagg-afmps.be     00 32 2 524 8186
                               renewals                                            Boite 40                          Variation and Renewal
                                                                               B-1060 Brussels                     applications: Iris Geussens
                                                                                   Belgium




                                                               Federal Agency for Medicines and Health Products
                                                                                                                        MA applications
                                                                                 Eurostation II
              Submission of electronic response documents                   Place Victor Horta, 40
BELGIUM                                                                                                                    Variations              Gestion.Fagg-Afmps@fagg.be
                     during MRP/DCP procedures                                     Boite 40
                                                                               B-1060 Brussels
                                                                                                                           Renewals
                                                                                   Belgium

                                                               Federal Agency for Medicines and Health Products
                                                                                                                        MA applications
                                                                                 Eurostation II
                 Submission of translations in MRP/DCP                      Place Victor Horta, 40
BELGIUM                                                                                                                    Variations                fagg_closing_file@fagg.be
                              procedures                                           Boite 40
                                                                               B-1060 Brussels
                                                                                                                           Renewals
                                                                                   Belgium

                                                               Federal Agency for Medicines and Health Products
                                                                                 Eurostation II
                 Submission of electronic versions of the
                                                                            Place Victor Horta, 40
BELGIUM           responses to the list of questions for                                                                                           Gestion.Fagg-Afmps@fagg.be
                                                                                   Boite 40
                   applications referred to the CMDh
                                                                               B-1060 Brussels
                                                                                   Belgium

                                                               Federal Agency for Medicines and Health Products
                                                                                 Eurostation II
                 Contact points for requests for variation                  Place Victor Horta, 40
BELGIUM                                                                                                                                           procedurenumber@fagg-afmps.be
                           grouping numbers                                        Boite 40
                                                                               B-1060 Brussels
                                                                                   Belgium




CMDh Compiled Contact Points                                                                               CMDh/245/2011, Rev5, June 2012
                                                                Federal Agency for Medicines and Health Products
                                                                                  Eurostation II
                  Submission of paediatric information in                    Place Victor Horta, 40
BELGIUM                                                                                                                                              paediatricdata@fagg-afmps.be
                   member states - Articles 45 and 46                               Boite 40
                                                                                B-1060 Brussels
                                                                                    Belgium

                                                                Federal Agency for Medicines and Health Products
                                                                                                                   New applications: Sophie Colyn,
                                                                                  Eurostation II                                                        sophie.colyn@fagg.be        00 32 2 524 8087
                                                                                                                     Katelijne Van Keymeulen
                                                                             Place Victor Horta, 40
BELGIUM                 Address for advice on fees
                                                                                    Boite 40
                                                                                                                       Variation and Renewal
                                                                                B-1060 Brussels                                                         iris.geussens@fagg.be       00 32 2 524 8186
                                                                                                                     applications: Iris Geussens
                                                                                    Belgium



                                                                 Federal Agency for Medicines and Healthcare
                                                                                   Products
                                                                 On Postal Account number 679 - 0021942 – 20
                                                                                Financiële Post
BELGIUM                       Fees payable to                                                                                                            accounting@fagg.be
                                                                            Antwerpse steenweg 59
                                                                                 1100 Brussel
                                                                           SWIFT code: PCHQBEBB
                                                                      IBAN code : BE28 6790 0219 4220



                                                                                                                          Lyubina Racheva              lyubina.racheva@bda.bg
                                                                             Bulgarian Drug Agency
                                                                             8, Damyan Gruev Str.                                                                                   00 359 2 8903494
BULGARIA             Advice on MRP/DCP procedures                                                                          Petya Grueva                 petya.grueva@bda.bg                              00 359 2 8903434
                                                                                   1303 Sofia                                                                                       00 359 2 8903497
                                                                                    Bulgaria
                                                                                                                         Vladislav Galabov             vladislav.galabov@bda.bg
                                                                             Bulgarian Drug Agency
                                                                                                                   MA applications and Renewals               mrp@bda.bg            (+359 2) 8903497
               Submission of new applications, variations and                8, Damyan Gruev Str.
BULGARIA                                                                                                                     Variations                   variations@bda.bg         (+359 2) 8903482
                                renewals                                           1303 Sofia
                                                                                                                        Biological products               biologicals@bda.bg        (+359 2) 8903492
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                                                                                                                         Vladislav Galabov             vladislav.galabov@bda.bg
               Submission of electronic response documents                   8, Damyan Gruev Str.
BULGARIA                                                                                                                                                                            (+359 2) 8903497
                      during MRP/DCP procedures                                    1303 Sofia
                                                                                                                           Petya Grueva                 petya.grueva@bda.bg
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                                                                                                                          Dariya Dimitrova             dariya.dimitrova@bda.bg      00 359 2 8903490
                  Submission of translations in MRP/DCP                      8, Damyan Gruev Str.
BULGARIA
                               procedures                                          1303 Sofia
                                                                                                                           Boris Rangelov               boris.rangelov@bda.bg       00 359 2 8903481
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                  Submission of electronic versions of the
                                                                             8, Damyan Gruev Str.
BULGARIA           responses to the list of questions for                                                                 Lyubina Racheva              lyubina.racheva@bda.bg       (+359 2) 8903494
                                                                                   1303 Sofia
                    applications referred to the CMDh
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                  Contact points for requests for variation                  8, Damyan Gruev Str.
BULGARIA                                                                                                               Hristina Tarpomanova          hristina.tarpomanova@bda.bg    (+359 2) 8903482
                            grouping numbers                                       1303 Sofia
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                  Submission of paediatric information in                    8, Damyan Gruev Str.
BULGARIA                                                                                                                 Antoniya Purcheva            antoniya.purcheva@bda.bg      (+359 2) 8903481
                   member states - Articles 45 and 46                              1303 Sofia
                                                                                    Bulgaria
                                                                             Bulgarian Drug Agency
                                                                             8, Damyan Gruev Str.
BULGARIA                Address for advice on fees                                                                       Violeta Georgieva             violeta.georgieva@bda.bg     00 359 2 890 34 23
                                                                                   1303 Sofia
                                                                                    Bulgaria




 CMDh Compiled Contact Points                                                                               CMDh/245/2011, Rev5, June 2012
                                                                UniCredit Bulbank PLC, Kaloyan branch
BULGARIA                      Fees payable to                   IBAN: BG85 UNCR 7630 3100 1128 90                   Violeta Georgieva             violeta.georgieva@bda.bg     00 359 2 890 34 23
                                                                           BIC: UNCRBGSF




                                                                                                                     George Antoniou             gantoniou@phs.moh.gov.cy      00 357 22 40 71 03   00 357 22 40 71 49
                                                                          Ministry of Health
                                                                                                                  Galatia Theophanous          gtheophanous@phs.moh.gov.cy     00 357 22 407 163    00 357 22 40 71 49
                                                                       Pharmaceutical Services
                                                                                                                (Validation of Applications)
CYPRUS               Advice on MRP/DCP procedures                        7 Larnacos Avenue
                                                                         CY – 1475 Nicosia
                                                                                                                  Emilia Mavrokordatou         emavrokordatou@phs.moh.gov.cy   00 357 22 40 71 18   00 357 22 40 71 49
                                                                              Lefkosia
                                                                                                             (New Applications, Renewals and
                                                                                                                       Variations)




                                                                                                                                                 gantoniou@phs.moh.gov.cy      00 357 22 40 71 03   00 357 22 40 71 49

                                                                     The Registrar Drugs Council                                               gtheophanous@phs.moh.gov.cy     00 357 22 407 163    00 357 22 40 71 49
               Submission of new applications, variations and         Pharmaceutical Services
CYPRUS                                                                                                            Emilia Mavrokordatou
                                renewals                                   1475 Nicosia
                                                                               Cyprus                                                          emavrokordatou@phs.moh.gov.cy   00 357 22 40 71 18   00 357 22 40 71 49




                                                                                                                                                                               00 357 22 40 71 50   00 357 22 40 71 49
                                                                          Ministry of Health                         MA applications           gtheophanous@phs.moh.gov.cy
                                                                                                                                                                               00 357 22 407 163    00 357 22 40 71 49
                                                                       Pharmaceutical Services                                                   ipericleous@phs.moh.gov.cy
               Submission of electronic response documents
CYPRUS                                                                   7 Larnacos Avenue                              Variations                 gsavva@phs.moh.gov.cy
                      during MRP/DCP procedures
                                                                         CY – 1475 Nicosia                                                         mrp-dcp@phs.moh.gov.cy
                                                                                                                                                                               00 357 22 40 71 18   00 357 22 40 71 49
                                                                              Lefkosia                                  Renewals




                                                                                                                                                                               00 357 22 40 71 50   00 357 22 40 71 49
                                                                          Ministry of Health                         MA applications           gtheophanous@phs.moh.gov.cy
                                                                                                                                                                               00 357 22 407 163    00 357 22 40 71 49
                                                                       Pharmaceutical Services                                                   ipericleous@phs.moh.gov.cy
                  Submission of translations in MRP/DCP
CYPRUS                                                                   7 Larnacos Avenue                              Variations                 gsavva@phs.moh.gov.cy
                               procedures
                                                                         CY – 1475 Nicosia                                                      mrp-dcpvar@phs.moh.gov.cy
                                                                                                                                                                               00 357 22 40 71 18   00 357 22 40 71 49
                                                                              Lefkosia                                  Renewals                mrp-dcpnew@phs.moh.gov.cy




                                                                          Ministry of Health                                                                                                        00 357 22 40 71 49
                  Submission of electronic versions of the             Pharmaceutical Services
CYPRUS             responses to the list of questions for                7 Larnacos Avenue                        Emilia Mavrokordatou         emavrokordatou@phs.moh.gov.cy   00 357 22 40 71 18   00 357 22 40 71 49
                    applications referred to the CMDh                    CY – 1475 Nicosia
                                                                              Lefkosia
                                                                          Ministry of Health                                                                                                        00 357 22 40 71 49
                                                                                                                                                                                                    00 357 22 40 71 49
                                                                       Pharmaceutical Services
                  Contact points for requests for variation                                                                                                                                         00 357 22 40 71 49
CYPRUS                                                                   7 Larnacos Avenue                            George Savva                gsavva@phs.moh.gov.cy        00 357 22 407 150
                            grouping numbers
                                                                         CY – 1475 Nicosia
                                                                              Lefkosia
                                                                                                                                                                                                    00 357 22 40 71 49

 CMDh Compiled Contact Points                                                                           CMDh/245/2011, Rev5, June 2012
                                                                                    Ministry of Health                                                                                                  00 357 22 40 71 49
                                                                                 Pharmaceutical Services
                     Submission of paediatric information in                                                                                                                                            00 357 22 40 71 49
   CYPRUS                                                                          7 Larnacos Avenue                      Galateia Theophanous    gtheophanous@phs.moh.gov.cy     00 357 22 407 163
                      member states - Articles 45 and 46
                                                                                   CY – 1475 Nicosia
                                                                                        Lefkosia
                                                                                                                                                                                                        00 357 22 40 71 49

                                                                                                                                                    gantoniou@phs.moh.gov.cy      00 357 22 40 71 03    00 357 22 40 71 49

                                                                               The Registrar Drugs Council                                        gtheophanous@phs.moh.gov.cy     00 357 22 407 163     00 357 22 40 71 49
                                                                                Pharmaceutical Services
   CYPRUS                  Address for advice on fees                                                                      Emilia Mavrokordatou
                                                                                     1475 Nicosia
                                                                                         Cyprus                                                   emavrokordatou@phs.moh.gov.cy   00 357 22 40 71 18    00 357 22 40 71 49




                                                                                                                                                    gantoniou@phs.moh.gov.cy      00 357 22 40 71 03    00 357 22 40 71 49
                                                                     Central Bank of Cyprus, Nicosia (SWIFT CODE:
                                                                                                                                                  gtheophanous@phs.moh.gov.cy     00 357 22 40 71 63    00 357 22 40 71 49
                                                                   CBCYCY2NACC) through TARGET 2 for further credit
   CYPRUS                        Fees payable to                        to Government General Account, A/C No.            Galateia Theophanous
                                                                      CY16001000010000000006001010 in favour of
                                                                                                                                                  emavrokordatou@phs.moh.gov.cy   00 357 22 40 71 18    00 357 22 40 71 49
                                                                    Pharmaceutical Services, Ministry of Health, Cyprus




                                                                              State Institute for Drug Control               Irena Lukáčová           irena.lukacova@sukl.cz      00 420 272 185 226
CZECH REPUBLIC          Advice on MRP/DCP procedures                                   Srobárova 48                                                                                                     00 420 271 732 377
                                                                                  CZ – 100 41 Praha 10                      Jitka Vokrouhlická       jitka.vokrouhlicka@sukl.cz   00 420 272 18 57 88




                                                                              State Institute for Drug Control
                  Submission of new applications, variations and
CZECH REPUBLIC                                                                         Srobárova 48
                                   renewals
                                                                                  CZ – 100 41 Praha 10




                                                                                                                             MA applications
                                                                              State Institute for Drug Control
                  Submission of electronic response documents
CZECH REPUBLIC                                                                         Srobárova 48                             Variations                 mrp@sukl.cz
                         during MRP/DCP procedures
                                                                                  CZ – 100 41 Praha 11
                                                                                                                               Renewals
                                                                                                                             MA applications
                                                                              State Institute for Drug Control
                     Submission of translations in MRP/DCP
CZECH REPUBLIC                                                                         Srobárova 48                             Variations                 mrp@sukl.cz
                                  procedures
                                                                                  CZ – 100 41 Praha 12
                                                                                                                                Renewals




    CMDh Compiled Contact Points                                                                                 CMDh/245/2011, Rev5, June 2012
                     Submission of electronic versions of the                 State Institute for Drug Control
CZECH REPUBLIC        responses to the list of questions for                           Srobárova 48                                                              mrp@sukl.cz
                       applications referred to the CMDh                          CZ – 100 41 Praha 13
                                                                              State Institute for Drug Control
                     Contact points for requests for variation
CZECH REPUBLIC                                                                         Srobárova 48                                                              mrp@sukl.cz
                               grouping numbers
                                                                                  CZ – 100 41 Praha 15
                                                                              State Institute for Drug Control
                     Submission of paediatric information in
CZECH REPUBLIC                                                                         Srobárova 48                                                           paed.use@sukl.cz
                      member states - Articles 45 and 46
                                                                                  CZ – 100 41 Praha 14
                                                                              State Institute for Drug Control
CZECH REPUBLIC             Address for advice on fees                                  Srobárova 48                                                            validace@sukl.cz
                                                                                  CZ – 100 41 Praha 10




                                                                                     Administrative fee:
                                                                           Name of the bank: Česká národní banka
                                                                   Address of the bank: Na Příkopě 28/3181 Praha 1 115
                                                                                      03 Czech Republic
                                                                               Account number: 3711-623101
                                                                                       Bank code: 0710
                                                                           IBAN: CZ35 0710 0037 1100 0062 3101
                                                                             BIC (originally SWIFT): CNBACZPP
                                                                                   Constant symbol: 1148
                                                                     Variable symbol: received from an interactive form
                                                                                              (see
                                                                   http://www.sukl.eu/modules/payment/index.php?lang=
                                                                                               2)
CZECH REPUBLIC                   Fees payable to
                                                                     Payment of costs incurred by expert activities:
                                                                           Name of the bank: Česká národní banka
                                                                   Address of the bank: Na Příkopě 28/3181 Praha 1 115
                                                                                      03 Czech Republic
                                                                                Account number: 35-623101
                                                                                       Bank code: 0710
                                                                           IBAN: CZ94 0710 0000 3500 0062 3101
                                                                             BIC (originally SWIFT): CNBACZPP
                                                                                   Constant symbol: 0308
                                                                     Variable symbol: received from an interactive form
                                                                                              (see
                                                                   http://www.sukl.eu/modules/payment/index.php?lang=
                                                                                               2)




                                                                                                                                 Joan BOYE                                               00 45 44 88 9254
                                                                          Danish Health and Medicines Authority
  DENMARK               Advice on MRP/DCP procedures                              Axel Heides Gade 1                                                             jbo@dkma.dk                                 00 45 44 940 237
                                                                                                                            Susanne LJØRRING                                             00 45 44 88 92 09
                                                                                 DK-2300 Copenhagen
                                                                                                                          (Validations of variations)
                                                                          Danish Health and Medicines Authority
                  Submission of new applications, variations and
  DENMARK                                                                         Axel Heides Gade 1
                                   renewals
                                                                                 DK-2300 Copenhagen
                                                                                                                               MA applications
                                                                          Danish Health and Medicines Authority
                  Submission of electronic response documents
  DENMARK                                                                         Axel Heides Gade 1                              Variations                  response@dkma.dk
                         during MRP/DCP procedures
                                                                                 DK-2300 Copenhagen
                                                                                                                                 Renewals
                                                                                                                               MA applications
                                                                          Danish Health and Medicines Authority
                     Submission of translations in MRP/DCP
  DENMARK                                                                         Axel Heides Gade 1                              Variations            god-afdelingspostkasse@dkma.dk
                                  procedures
                                                                                 DK-2300 Copenhagen
                                                                                                                                  Renewals
                     Submission of electronic versions of the             Danish Health and Medicines Authority
  DENMARK             responses to the list of questions for                      Axel Heides Gade 1                                                    god-afdelingspostkasse@dkma.dk
                       applications referred to the CMDh                         DK-2300 Copenhagen


    CMDh Compiled Contact Points                                                                                  CMDh/245/2011, Rev5, June 2012
                                                               Danish Health and Medicines Authority
                 Contact points for requests for variation
DENMARK                                                                Axel Heides Gade 1                                               god-afdelingspostkasse@dkma.dk
                           grouping numbers
                                                                      DK-2300 Copenhagen
                                                               Danish Health and Medicines Authority
                 Submission of paediatric information in
DENMARK                                                                Axel Heides Gade 1                                                    paed.data@dkma.dk
                  member states - Articles 45 and 46
                                                                      DK-2300 Copenhagen
                                                               Danish Health and Medicines Authority
DENMARK                Address for advice on fees                      Axel Heides Gade 1
                                                                      DK-2300 Copenhagen

                                                                        Sundhedsstyrelsen

                                                                        Bank connection:
                                                                          Danske Bank
                                                                          Girostrøget 1
DENMARK                      Fees payable to
                                                                      DK-0800 Høje Taastrup

                                                                   Address SWIFT: DABADKKK
                                                                  Account No.: 0216 4069069193
                                                                   IBAN: DK7702164069069193

                                                                    State Agency of Medicines
                                                                                                                   Margit PLAKSO                                         00 372 7 37 41 40   00 372 7 37 41 42
                                                                         1 Nooruse Street
ESTONIA             Advice on MRP/DCP procedures                                                                                              mrp@ravimiamet.ee
                                                                         EE-50411 Tartu
                                                                                                                   Triin MÄESALU                                         00 372 7 37 41 40   00 372 7 37 41 42
                                                                             Estonia
                                                                    State Agency of Medicines
              Submission of new applications, variations and             1 Nooruse Street
ESTONIA                                                                                                                                  documenation@ravimiamet.ee
                               renewals                                  EE-50411 Tartu
                                                                             Estonia
                                                                                                                   MA applications
                                                                    State Agency of Medicines
              Submission of electronic response documents                1 Nooruse Street
ESTONIA                                                                                                              Variations               mrp@ravimiamet.ee
                     during MRP/DCP procedures                           EE-50411 Tartu
                                                                             Estonia
                                                                                                                     Renewals
                                                                                                                   MA applications
                                                                    State Agency of Medicines
                 Submission of translations in MRP/DCP                   1 Nooruse Street
ESTONIA                                                                                                              Variations               mrp@ravimiamet.ee
                              procedures                                 EE-50411 Tartu
                                                                             Estonia
                                                                                                                     Renewals
                                                                    State Agency of Medicines
                 Submission of electronic versions of the
                                                                         1 Nooruse Street
ESTONIA           responses to the list of questions for                                                                                      mrp@ravimiamet.ee
                                                                         EE-50411 Tartu
                   applications referred to the CMDh
                                                                             Estonia
                                                                    State Agency of Medicines
                 Contact points for requests for variation               1 Nooruse Street
ESTONIA                                                                                                                                       mrp@ravimiamet.ee
                           grouping numbers                              EE-50411 Tartu
                                                                             Estonia
                                                                    State Agency of Medicines
                 Submission of paediatric information in                 1 Nooruse Street
ESTONIA
                  member states - Articles 45 and 46                     EE-50411 Tartu
                                                                             Estonia                                                       paediatric@ravimiamet.ee
                                                                    State Agency of Medicines
                                                                         1 Nooruse Street
ESTONIA                Address for advice on fees
                                                                         EE-50411 Tartu
                                                                             Estonia




CMDh Compiled Contact Points                                                                           CMDh/245/2011, Rev5, June 2012
                                                                  Rahandusministeerium (Ministry of Finance)
                                                               Address: Suur-Ameerika 1, Tallinn 15006, ESTONIA

                                                                          Account no: 221023778606
ESTONIA                      Fees payable to
                                                                       IBAN: EE932200221023778606
                                                                           SWIFT code: HABA EE2X
                                                                              Bank : HANSAPANK
                                                                  Address: Liivalaia 8, Tallinn 15040, ESTONIA

                                                                                                                        Leena PIETILÄ
                                                                           Finnish Medicines Agency                                           leena.pietila@fimea.fi   00 358 9 4733 4436   00 358 9 4733 4260
                                                                                                                      (ATC:A,J,N,P,R,S,V)
                                                                                   P.O. Box 55
FINLAND             Advice on MRP/DCP procedures
                                                                            (Mannerheimintie 103b)
                                                                                                                        Marja HELENIUS
                                                                             FIN - 00301 HELSINKI                                            marja.helenius@fimea.fi   00 358 9 4733 4235   00 358 9 4733 4350
                                                                                                                      (ATC:B,C,D,G,H,L,M)

                                                                           Finnish Medicines Agency
              Submission of new applications, variations and                       P.O. Box 55
FINLAND
                               renewals                                          (Nauvontie 4)
                                                                             FIN - 00301 HELSINKI
                                                                                                                        MA applications
                                                                           Finnish Medicines Agency
              Submission of electronic response documents                          P.O. Box 55
FINLAND                                                                                                                    Variations             mrp@fimea.fi
                     during MRP/DCP procedures                              (Mannerheimintie 103b)
                                                                             FIN - 00301 HELSINKI
                                                                                                                          Renewals
                                                                                                                        MA applications
                                                                           Finnish Medicines Agency
                 Submission of translations in MRP/DCP                             P.O. Box 55
FINLAND                                                                                                                    Variations             mrp@fimea.fi
                              procedures                                    (Mannerheimintie 103b)
                                                                             FIN - 00301 HELSINKI
                                                                                                                           Renewals
                                                                           Finnish Medicines Agency
                 Submission of electronic versions of the
                                                                                   P.O. Box 55
FINLAND           responses to the list of questions for                                                                                          mrp@fimea.fi
                                                                            (Mannerheimintie 103b)
                   applications referred to the CMDh
                                                                             FIN - 00301 HELSINKI
                                                                           Finnish Medicines Agency
                 Contact points for requests for variation                         P.O. Box 55
FINLAND                                                                                                                                           mrp@fimea.fi
                           grouping numbers                                 (Mannerheimintie 103b)
                                                                             FIN - 00301 HELSINKI
                                                                           Finnish Medicines Agency
                 Submission of paediatric information in                           P.O. Box 55
FINLAND                                                                                                                                          paed@fimea.fi
                  member states - Articles 45 and 46                        (Mannerheimintie 103b)
                                                                             FIN - 00301 HELSINKI
                                                                           Finnish Medicines Agency
                                                                                   P.O. Box 55
FINLAND                Address for advice on fees                                                                                                 mrp@fimea.fi
                                                                            (Mannerheimintie 103b)
                                                                             FIN - 00301 HELSINKI

                                                                           Finnish Medicines Agency
                                                                            Marketing Authorisations

                                                                                IBAN number
                                                                            FI8916603000104953
                                                                                  Swift code
FINLAND                      Fees payable to                                     NDEAFIHH
                                                                                    Bank
                                                                           Nordea Bank Finland Plc
                                                                                Bank address
                                                                             Aleksanterinkatu 36
                                                                             FI-00020 NORDEA




CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                               Agence nationale de sécurité du médicament et des
                                                                           produits de santé (ANSM)
FRANCE              Advice on MRP/DCP procedures                                                                         Alban DHANANI             Alban.dhanani@ansm.sante.fr           00 33 1 5587 3293    00 33 1 5587 3292
                                                                          143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                               Agence nationale de sécurité du médicament et des
              Submission of new applications, variations and               produits de santé (ANSM)
FRANCE
                               renewals                                   143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                                                                                         MA applications
                                                               Agence nationale de sécurité du médicament et des
              Submission of electronic response documents                  produits de santé (ANSM)
FRANCE                                                                                                                      Variations                ueurop@ansm.sante.fr
                     during MRP/DCP procedures                            143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                                                                                           Renewals
                                                                                                                         MA applications
                                                               Agence nationale de sécurité du médicament et des
                 Submission of translations in MRP/DCP                     produits de santé (ANSM)
FRANCE                                                                                                                      Variations                ueurop@ansm.sante.fr
                              procedures                                  143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                                                                                            Renewals
                                                               Agence nationale de sécurité du médicament et des
                 Submission of electronic versions of the
                                                                           produits de santé (ANSM)                                                    ueurop@ansm.sante.fr
FRANCE            responses to the list of questions for
                                                                          143-147 bd Anatole France                                             cc: Alban.DHANANI@ansm.sante.fr
                   applications referred to the CMDh
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                               Agence nationale de sécurité du médicament et des
                 Contact points for requests for variation                 produits de santé (ANSM)
FRANCE                                                                                                                                                ueurop@ansm.sante.fr
                           grouping numbers                               143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                               Agence nationale de sécurité du médicament et des
                 Submission of paediatric information in                   produits de santé (ANSM)
FRANCE                                                                                                                                            pediatrie.france@ansm.sante.fr
                  member states - Articles 45 and 46                      143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX
                                                               Agence nationale de sécurité du médicament et des
                                                                           produits de santé (ANSM)
FRANCE                 Address for advice on fees
                                                                          143-147 bd Anatole France
                                                                       FR-93285 SAINT-DENIS CEDEX




                                                                  Direction des Créances Spéciales du Trésor
                                                               (Special Receivables Department of the Treasury)
FRANCE                       Fees payable to                          22, boulevard Blossac – BP 40649 –
                                                                       86106 CHÂTELLERAULT CEDEX
                                                                                   FRANCE




                                                                                                                        Peter BACHMANN
                                                                                                                        (new applications)                                               00 49 228 207 4163   00 49 228 207 3452
                                                                                                                                                    peter.bachmann@bfarm.de


                                                                 Federal Institute for Drugs and Medical Devices                                susanne.winterscheid@bfarm.de (for
                                                                                                                     Susanne WINTERSCHEID
                                                                                       (BfArM)                                                            general questions)
GERMANY             Advice on MRP/DCP procedures                                                                           (variations)                                                  00 49 228 207 4172   00 49 228 207 4303
                                                                          Kurt-Georg Kiesinger-Allee 3                                        variation-grouping-request@bfarm.de (for
                                                                                   D-53175 Bonn                                                               questions
                                                                                                                                                    on grouping and classification)

                                                                                                                                                    brigitte.hammes@bfarm.de
                                                                                                                        Brigitte HAMMES                                                  00 49 228 207 4330   00 49 228 207 4303
                                                                                                                            (renewals)

                                                                 Federal Institute for Drugs and Medical Devices
              Submission of new applications, variations and                           (BfArM)                                                        dispatch-lists@bfarm.de
GERMANY
                               renewals                                   Kurt-Georg Kiesinger-Allee 3                                             (for dispatch information only)
                                                                                   D-53175 Bonn


CMDh Compiled Contact Points                                                                                 CMDh/245/2011, Rev5, June 2012
                                                                                                                                                               mrp@bfarm.de
                                                                                                                              MA applications
                                                                      Federal Institute for Drugs and Medical Devices                                        mrp-var@bfarm.de
                                                                                                                                Variations
                       Submission of electronic response documents                          (BfArM)
     GERMANY
                              during MRP/DCP procedures                        Kurt-Georg Kiesinger-Allee 3                                                  mrp-ren@bfarm.de
                                                                                                                                Renewals
                                                                                        D-53175 Bonn
                                                                                                                                                           dispatch-lists@bfarm.de
                                                                                                                               Dispatch-lists
                                                                                                                                                        (for dispatch information only)
                                                                                                                              MA applications
                                                                      Federal Institute for Drugs and Medical Devices
                          Submission of translations in MRP/DCP                             (BfArM)
     GERMANY                                                                                                                    Variations                 translations@bfarm.de
                                       procedures                              Kurt-Georg Kiesinger-Allee 3
                                                                                        D-53175 Bonn
                                                                                                                                Renewals
                                                                      Federal Institute for Drugs and Medical Devices
                          Submission of electronic versions of the
                                                                                            (BfArM)                                                            mrp@bfarm.de
     GERMANY               responses to the list of questions for
                                                                               Kurt-Georg Kiesinger-Allee 3                                          cc: susanne.winterscheid@bfarm.de
                            applications referred to the CMDh
                                                                                        D-53175 Bonn
                                                                      Federal Institute for Drugs and Medical Devices
                          Contact points for requests for variation                         (BfArM)
     GERMANY                                                                                                                                       Variation-grouping-IA-number@bfarm.de
                                    grouping numbers                           Kurt-Georg Kiesinger-Allee 3
                                                                                        D-53175 Bonn
                                                                      Federal Institute for Drugs and Medical Devices
                                                                                                                                 Article 45                 PaedArt45@bfarm.de
                          Submission of paediatric information in                           (BfArM)
     GERMANY
                           member states - Articles 45 and 46                  Kurt-Georg Kiesinger-Allee 3
                                                                                                                                 Article 46                 PaedArt46@bfarm.de
                                                                                        D-53175 Bonn
                                                                      Federal Institute for Drugs and Medical Devices
                                                                                            (BfArM)
     GERMANY                    Address for advice on fees                                                                                                     fees@bfarm.de
                                                                               Kurt-Georg Kiesinger-Allee 3
                                                                                        D-53175 Bonn




                                                                                   Bundeskasse Trier
                                                                        Deutsche Bundesbank Filiale Saarbrücken
                                                                                 Account no. 59001020
     GERMANY                          Fees payable to
                                                                                    BLZ 590 000 00
                                                                          IBAN: DE 81 5900 0000 0590 0102 0
                                                                                  BIC: MARKDEF 1590




    GERMANY
                                                                                   Paul Ehrlich Institute
 (SERA, VACCINES,
                        Advice on MRP/DCP procedures                              Paul Ehrlich Str. 51-59                     Katrin VÖLLER                eu-cooperation@pei.de           00 49 6103 77 3902   00 49 6103 77 1251
ALLERGENES, BLOOD
                                                                                   D - 63225 LANGEN
  PREPARATIONS)
    GERMANY
                                                                                   Paul-Ehrlich-Institut
 (SERA, VACCINES, Submission of new applications, variations and
                                                                                  Paul-Ehrlich-Str. 51-59
ALLERGENES, BLOOD                  renewals
                                                                                    D-63225 LANGEN
  PREPARATIONS)
                                                                                                                              MA applications
    GERMANY
                                                                                   Paul Ehrlich Institute
 (SERA, VACCINES, Submission of electronic response documents
                                                                                  Paul Ehrlich Str. 51-59                       Variations                 eu-cooperation@pei.de
ALLERGENES, BLOOD        during MRP/DCP procedures
                                                                                   D - 63225 LANGEN
  PREPARATIONS)
                                                                                                                                Renewals
                                                                                                                              MA applications
    GERMANY
                                                                                   Paul Ehrlich Institute
 (SERA, VACCINES,         Submission of translations in MRP/DCP
                                                                                  Paul Ehrlich Str. 51-59                       Variations                 eu-cooperation@pei.de
ALLERGENES, BLOOD                      procedures
                                                                                   D - 63225 LANGEN
  PREPARATIONS)
                                                                                                                                Renewals




       CMDh Compiled Contact Points                                                                               CMDh/245/2011, Rev5, June 2012
    GERMANY
                       Submission of electronic versions of the                Paul Ehrlich Institute
 (SERA, VACCINES,
                        responses to the list of questions for                Paul Ehrlich Str. 51-59                                                         eu-cooperation@pei.de
ALLERGENES, BLOOD
                         applications referred to the CMDh                     D - 63225 LANGEN
  PREPARATIONS)
    GERMANY
                                                                               Paul Ehrlich Institute
 (SERA, VACCINES,      Contact points for requests for variation
                                                                              Paul Ehrlich Str. 51-59                                                         eu-cooperation@pei.de
ALLERGENES, BLOOD                grouping numbers
                                                                               D - 63225 LANGEN
  PREPARATIONS)
    GERMANY
                                                                               Paul Ehrlich Institute
 (SERA, VACCINES,      Submission of paediatric information in
                                                                              Paul Ehrlich Str. 51-59                                                           paediatrics@pei.de
ALLERGENES, BLOOD       member states - Articles 45 and 46
                                                                               D - 63225 LANGEN
  PREPARATIONS)
    GERMANY
                                                                               Paul-Ehrlich-Institut
 (SERA, VACCINES,
                             Address for advice on fees                       Paul-Ehrlich-Str. 51-59
ALLERGENES, BLOOD
                                                                                D-63225 LANGEN
  PREPARATIONS)




                                                                               Bundeskasse Trier
                                                                     Deutsche Bundesbank Filiale Saarbrücken
    GERMANY
                                                                             Account No. 590 010 20
 (SERA, VACCINES,
                                   Fees payable to                              BLZ: 590 000 00                                                                 gebuehren@pei.de
ALLERGENES, BLOOD
  PREPARATIONS)
                                                                       IBAN: DE81 5900 0000 0059 0010 20
                                                                              BIC: MARKDEF 1590




                                                                                                                           Eleni KRITIKOU                        ekritikou@eof.gr               00 30 213 2040209
                                                                        National Organization for Medicines
                                                                                                                      (Head of Evaluation Division)
                                                                                Evaluation Division
     GREECE               Advice on MRP/DCP procedures                        Mesogion Avenue 284
                                                                                                                         George AISLAITNER                       geoaisla@eof.gr                00 30 213 2040247
                                                                                     Holargos
                                                                                                                      (Head of Evaluation Section)
                                                                               GR - ATHENS 15562

                                                                        National Organization for Medicines
                                                                               Registration Division
                    Submission of new applications, variations and
     GREECE                                                                   Mesogion Avenue 284                        Validation Department
                                     renewals
                                                                                     Holargos
                                                                               GR - ATHENS 15562

                                                                                                                                                      The contact point for the procedure AND
                                                                                                                                                                    additionally:

                                                                                                                                                                  For chemicals:

                                                                                                                                                               Full set of Responses:
                                                                        National Organization for Medicines                 MA applications
                                                                                                                                                             el-hum-responses@eof.gr
                                                                                Evaluation Division
                    Submission of electronic response documents
     GREECE                                                                   Mesogion Avenue 284                              Variations
                           during MRP/DCP procedures                                                                                                  Additional copy for Responses on Module
                                                                                     Holargos
                                                                                                                                                                          3:
                                                                               GR - ATHENS 15563                               Renewals
                                                                                                                                                              qualityresponses@eof.gr

                                                                                                                                                                  For biologicals:

                                                                                                                                                               Full set of Responses:
                                                                                                                                                           el-hum-bio-responses@eof.gr
                                                                        National Organization for Medicines                 MA applications
                                                                               Registration Division
                       Submission of translations in MRP/DCP
     GREECE                                                                   Mesogion Avenue 284                              Variations                        spctrans@eof.gr
                                    procedures
                                                                                     Holargos
                                                                               GR - ATHENS 15564                               Renewals



     CMDh Compiled Contact Points                                                                              CMDh/245/2011, Rev5, June 2012
                                                                        National Organization for Medicines
                 Submission of electronic versions of the                       Evaluation Division
GREECE            responses to the list of questions for                      Mesogion Avenue 284                                                             daousani@eof.gr
                   applications referred to the CMDh                                 Holargos
                                                                               GR - ATHENS 15565
                                                                        National Organization for Medicines
                                                                               Registration Division
                 Contact points for requests for variation
GREECE                                                                        Mesogion Avenue 284                         Dr. Afroditi Neokosmidi             aneokosm@eof.gr              0030 213 2040 232   0030 213 2040 570
                           grouping numbers
                                                                                     Holargos
                                                                               GR - ATHENS 15567
                                                                        National Organization for Medicines
                                                                                Evaluation Division
                 Submission of paediatric information in                                                                                                     Dr George Aislaitner
GREECE                                                                        Mesogion Avenue 284
                  member states - Articles 45 and 46                                                                                                          geoaisla@eof.gr
                                                                                     Holargos
                                                                               GR - ATHENS 15566
                                                                        National Organization for Medicines
                                                                               Registration Division
GREECE                 Address for advice on fees                             Mesogion Avenue 284                         Validation Department
                                                                                     Holargos
                                                                               GR - ATHENS 15562

                                                                  Bank of Greece (to the account of the National
                                                               Organization for Medicines / Account number: 263038)
                                                                          Foreign Exchange Department
                                                                                     Section C
GREECE                       Fees payable to
                                                                             21 Panepistimiou Avenue
                                                                                GR – 10250 ATHENS
                                                                     IBAN: GR5301000240000000000263038
                                                                            SWIFT CODE: BNBNGRAA


                                                                                                                             MA applications

                                                                                                                                                     HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                                  National Institute for Quality- and Organizational            Variations           HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                                    Development in Healthcare and Medicines                                                                                00 361 8869 300
                                                                           National Institute of Pharmacy                                            HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY             Advice on MRP/DCP procedures                                                                                                                                                               00 36 1 88 69 460
                                                                                       Zrínyi U. 3                                                   HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                                                                                        H-1051                                  Renewals                                                        300/432
                                                                                       Budapest                                                     HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                                    HU as RMS: mrp-dcp-renew-rms@ogyi.hu




                                                                                                                             MA applications
                                                                                                                                                     HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                                  National Institute for Quality- and Organizational                                 HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                                    Development in Healthcare and Medicines                     Variations                                                 00 361 8869 300
              Submission of new applications, variations and               National Institute of Pharmacy                                            HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY                                                                                                                                                                                                        00 36 1 88 69 460
                               renewals                                                Zrínyi U. 3                                                   HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                                                                                        H-1051                                  Renewals                                                        300/432
                                                                                       Budapest                                                     HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                                    HU as RMS: mrp-dcp-renew-rms@ogyi.hu




CMDh Compiled Contact Points                                                                                     CMDh/245/2011, Rev5, June 2012
                                                                                                                        MA applications
                                                                                                                                              HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                             National Institute for Quality- and Organizational                               HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                               Development in Healthcare and Medicines                    Variations                                                00 361 8869 300
              Submission of electronic response documents             National Institute of Pharmacy                                          HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY                                                                                                                                                                                                 00 36 1 88 69 460
                     during MRP/DCP procedures                                    Zrínyi U. 3                                                 HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                                                                                   H-1051                                 Renewals                                                       300/432
                                                                                  Budapest                                                   HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                             HU as RMS: mrp-dcp-renew-rms@ogyi.hu




                                                                                                                        MA applications
                                                                                                                                              HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                             National Institute for Quality- and Organizational                               HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                               Development in Healthcare and Medicines                    Variations                                                00 361 8869 300
                 Submission of translations in MRP/DCP                National Institute of Pharmacy                                          HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY                                                                                                                                                                                                 00 36 1 88 69 460
                              procedures                                          Zrínyi U. 3                                                 HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                                                                                   H-1051                                 Renewals                                                       300/432
                                                                                  Budapest                                                   HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                             HU as RMS: mrp-dcp-renew-rms@ogyi.hu




                                                                                                                        MA applications
                                                                                                                                              HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                             National Institute for Quality- and Organizational                               HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                               Development in Healthcare and Medicines                    Variations                                                00 361 8869 300
                 Submission of electronic versions of the
                                                                      National Institute of Pharmacy                                          HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY           responses to the list of questions for                                                                                                                                                00 36 1 88 69 460
                                                                                  Zrínyi U. 3                                                 HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                   applications referred to the CMDh
                                                                                   H-1051                                 Renewals                                                       300/432
                                                                                  Budapest                                                   HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                             HU as RMS: mrp-dcp-renew-rms@ogyi.hu



                                                             National Institute for Quality- and Organizational
                                                               Development in Healthcare and Medicines
                 Contact points for requests for variation            National Institute of Pharmacy
HUNGARY                                                                                                                                             mrp-dcp-var-rms@ogyi.hu
                           grouping numbers                                       Zrínyi U. 3
                                                                                   H-1051
                                                                                  Budapest
                                                             National Institute for Quality- and Organizational
                                                               Development in Healthcare and Medicines
                 Submission of paediatric information in              National Institute of Pharmacy
HUNGARY                                                                                                                                                paediatric@ogyi.hu
                  member states - Articles 45 and 46                              Zrínyi U. 3
                                                                                   H-1051
                                                                                  Budapest




CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                                                                                           MA applications
                                                                                                                                                  HU as CMS: mrp-dcp-new-cms@ogyi.hu
                                                                National Institute for Quality- and Organizational                                HU as RMS: mrp-dcp-new-rms@ogyi.hu
                                                                  Development in Healthcare and Medicines                    Variations                                                 00 361 8869 300
                                                                         National Institute of Pharmacy                                           HU as CMS: mrp-dcp-var-cms@ogyi.hu    (general number)
HUNGARY                Address for advice on fees                                                                                                                                                           00 36 1 88 69 460
                                                                                     Zrínyi U. 3                                                  HU as RMS: mrp-dcp-var-rms@ogyi.hu     or 00 36 1 8869-
                                                                                      H-1051                                  Renewals                                                       300/432
                                                                                     Budapest                                                    HU as CMS: mrp-dcp-renew-cms@ogyi.hu
                                                                                                                                                 HU as RMS: mrp-dcp-renew-rms@ogyi.hu




                                                                National Institute for Quality- and Organizational
                                                                   Development in Healthcare and Medicines
                                                                    address: 1125 Budapest, Diós árok u. 3
                                                               Bank name and address: Hungarian State Treasury
HUNGARY                      Fees payable to
                                                                     1139 Budapest, Hungary, Váci str 71.
                                                                 IBAN: HU06 1003 2000 0149 0576 0000 0000
                                                                             SWIFT: MA NE HU HB




                                                                                  Lyfjastofnun                           Jón Pétur Einarsson
                                                                                                                                                               jpe@ima.is
                                                                        Icelandic Medicine Agency (IMA)                    (CMDh Member)
ICELAND             Advice on MRP/DCP procedures                                 Vinlandsleid 14                                                                                         +354 520 2100       +354 561 2170
                                                                                IS-113 Reykjavik                           Inga Pálsdóttir
                                                                                                                                                              inga@ima.is
                                                                                     Iceland                              (CMDh Alternate)
                                                                                  Lyfjastofnun
                                                                        Icelandic Medicine Agency (IMA)
              Submission of new applications, variations and
ICELAND                                                                          Vinlandsleid 14                                                                                         +354 520 2100       +354 561 2170
                               renewals
                                                                                IS-113 Reykjavik
                                                                                     Iceland
                                                                                  Lyfjastofnun
                                                                        Icelandic Medicine Agency (IMA)
              Submission of electronic response documents
ICELAND                                                                          Vinlandsleid 14                                                                                         +354 520 2100       +354 561 2170
                     during MRP/DCP procedures
                                                                                IS-113 Reykjavik
                                                                                     Iceland
                                                                                  Lyfjastofnun                            When IMA is CMS:                textar@lyfjastofnun.is
                                                                        Icelandic Medicine Agency (IMA)                    Inga Pálsdóttir
                 Submission of translations in MRP/DCP
ICELAND                                                                          Vinlandsleid 14                                                        When IMA is RMS cc to:           +354 520 2100       +354 561 2170
                              procedures
                                                                                IS-113 Reykjavik                         When IMA is RMS:                  solrunh@ima.is
                                                                                     Iceland                             Sólrún Haraldsdóttir
                                                                                  Lyfjastofnun
                 Submission of electronic versions of the               Icelandic Medicine Agency (IMA)
                                                                                                                         Jón Pétur Einarsson                  ima@ima.is
ICELAND           responses to the list of questions for                         Vinlandsleid 14                                                                                         +354 520 2100       +354 561 2170
                                                                                                                           (CMDh Member)                       jpe@ima.is
                   applications referred to the CMDh                            IS-113 Reykjavik
                                                                                     Iceland
                                                                                  Lyfjastofnun
                                                                        Icelandic Medicine Agency (IMA)
                 Contact points for requests for variation                                                               Sólrún Haraldsdóttir
ICELAND                                                                          Vinlandsleid 14                                                              ima@ima.is                 +354 520 2100       +354 561 2170
                           grouping numbers                                                                           Inga Rósa Guðmundsdóttir
                                                                                IS-113 Reykjavik
                                                                                     Iceland




CMDh Compiled Contact Points                                                                                   CMDh/245/2011, Rev5, June 2012
                                                                                 Lyfjastofnun
                                                                       Icelandic Medicine Agency (IMA)
                 Submission of paediatric information in
ICELAND                                                                         Vinlandsleid 14                                                              paed.data@ima.is                +354 520 2100       +354 561 2170
                  member states - Articles 45 and 46
                                                                               IS-113 Reykjavik
                                                                                    Iceland
                                                                                 Lyfjastofnun
                                                                     The Icelandic Medicine Agency (IMA)
                                                                                Vínlandsleið 14
ICELAND                Address for advice on fees                                                                                                               ima@ima.is                   +354 520 2100       +354 561 2170
                                                                               IS-113 Reykjavík
                                                                                   ICELAND


                                                                         Commerz Bank AG, Frankfurt
                                                                               SWIFT: COBADEFF
                                                                           account: 4 008 757 04 900
                                                                     The Central Bank of Iceland, Reykjavik
ICELAND                      Fees payable to                                    SWIFT: SISLISRE                                                                 ima@ima.is                   +354 520 2100       +354 561 2170
                                                                 Final beneficiary: Icelandic Medicines Agency -
                                                                                    Lyfjastofnun
                                                               IBAN Number: IS23 0001 2602 5335 5402 6964 59


                                                                                                                         Tonilee Gueguen
                                                                                                                    IE - RMS (New aplications)

                                                                                                                          Tonilee Gueguen                 ie-h.mrve@ie-h.eudra.org
                                                                             Irish Medicines Board
                                                                                                                    IE - CMS (New applications)            Tonilee.gueguen@imb.ie
                                                                              The Earlsfort Centre
IRELAND             Advice on MRP/DCP procedures                                                                                                            Mary.connolly@imb.ie            00 353 1 676 4971   00 353 1 676 8490
                                                                                 Earlsfort Terrace
                                                                                                                     Mary Connolly (Variations)               Pearl.healy@imb.ie
                                                                                  IR - DUBLIN 2
                                                                                                                                                             Jayne.crowe@imb.ie
                                                                                                                      Pearl Healy (Renewals)

                                                                                                                         Dr. Jayne Crowe



                                                                             Irish Medicines Board
              Submission of new applications, variations and                  The Earlsfort Centre
IRELAND                                                                                                              Receipts and Validations         imbreceiptsandvalidation@imb.ie
                               renewals                                          Earlsfort Terrace
                                                                                  IR - DUBLIN 2



                                                                                                                          MA applications                 ie-h.mrna@ie-h.eudra.org
                                                                             Irish Medicines Board
              Submission of electronic response documents                     The Earlsfort Centre
IRELAND                                                                                                                      Variations                   ie-h.mrve@ie-h.eudra.org
                     during MRP/DCP procedures                                   Earlsfort Terrace
                                                                                  IR - DUBLIN 3
                                                                                                                            Renewals                      ie-h.mrve@ie-h.eudra.org
                                                                                                                          MA applications
                                                                             Irish Medicines Board                                                        ie-h.mrna@ie-h.eudra.org
                 Submission of translations in MRP/DCP                        The Earlsfort Centre                                                        ie-h.mrve@ie-h.eudra.org
IRELAND                                                                                                                      Variations
                              procedures                                         Earlsfort Terrace
                                                                                  IR - DUBLIN 4
                                                                                                                             Renewals
                                                                             Irish Medicines Board
                 Submission of electronic versions of the                                                                New applications
                                                                              The Earlsfort Centre                                                        ie-h.mrna@ie-h.eudra.org
IRELAND           responses to the list of questions for
                                                                                 Earlsfort Terrace                                                        ie-h.mrve@ie-h.eudra.org
                   applications referred to the CMDh                                                               Renewal/Variation applications
                                                                                  IR - DUBLIN 5
                                                                             Irish Medicines Board
                 Contact points for requests for variation                    The Earlsfort Centre                       Grainne Flanagan                 grainne.flanagan@imb.ie
IRELAND
                           grouping numbers                                      Earlsfort Terrace                        Mary Connnolly                   mary.connolly@imb.ie
                                                                                  IR - DUBLIN 7
                                                                             Irish Medicines Board
                 Submission of paediatric information in                      The Earlsfort Centre                                                  ie-h.cmd-paediatricsws@ie-h.eudra.org
IRELAND                                                                                                                    Cathy Wright
                  member states - Articles 45 and 46                             Earlsfort Terrace                                                          HM_Paediatric@imb.ie
                                                                                  IR - DUBLIN 6



CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                                         Irish Medicines Board
                                                                          The Earlsfort Centre
IRELAND                Address for advice on fees                                                               Receipts and Validations        imbreceiptsandvalidation@imb.ie
                                                                             Earlsfort Terrace
                                                                              IR - DUBLIN 2




                                                                         Irish Medicines Board
                                                               Account no: 33712185; sort code: 93-10-12
IRELAND                      Fees payable to                       IBAN:IE 54AIBK 93101233712185                Receipts and Validations        imbreceiptsandvalidation@imb.ie
                                                                            Allied Irish Bank,
                                                                     1-3 Baggot St. Lr., DUBLIN 2




                                                                                                              General advice on MRP/DCP
                                                                                                              procedures/ new applications
                                                                                                              Sandra PETRAGLIA (CMDh                  s.petraglia@aifa.gov.it           00 39 06 5978 4222   00 39 06 5978 4806
                                                                                                                       member)
                                                                     Agenzia Italiana del Farmaco
 ITALY              Advice on MRP/DCP procedures                         Via del Tritone, 181                     Laura BRAGHIROLI                    l.braghiroli@aifa.gov.it          00 39 06 5978 4211   00 39 06 5978 4806
                                                                          IT - 00187 Roma                             (Variations)

                                                                                                                Francesca CECCARINI                   f.ceccarini@aifa.gov.it           00 39 06 5978 4155   00 39 06 5978 4806
                                                                                                             (Validation and administrative
                                                                                                                         issues)




                                                                                                              Evaluation and Registration
                                                                     Agenzia Italiana del Farmaco                        Office
              Submission of new applications, variations and
 ITALY                                                                   Via del Tritone, 181
                               renewals
                                                                          IT - 00187 Roma                       Renewal applications:
                                                                                                               Pharmacovigilance Office




                                                                                                                                              The contact point for the procedure or:
                                                                                                                                                     g.pugliese@aifa.gov.it
                                                                                                                    MA applications

                                                                     Agenzia Italiana del Farmaco                                             The contact point for the variation or:
              Submission of electronic response documents
 ITALY                                                                   Via del Tritone, 181                          Variations                f.mazzeo@aifa.gov.it (Type II)
                     during MRP/DCP procedures
                                                                          IT - 00187 Roma                                                         c.zamori@aifa.gov.it (Type I)

                                                                                                                       Renewals
                                                                                                                                                   rinnovi.mr.cms@aifa.gov.it
                                                                                                                                                   rinnovi.mr.rms@aifa.gov.it




CMDh Compiled Contact Points                                                                           CMDh/245/2011, Rev5, June 2012
                                                                                                                                   stampati.aic_mr-dc@aifa.gov.it
                                                                                                        MA applications
                                                             Agenzia Italiana del Farmaco
                 Submission of translations in MRP/DCP                                                                              stampati.var2-mr@aifa.gov.it.
ITALY                                                            Via del Tritone, 181                      Variations
                              procedures
                                                                  IT - 00187 Roma
                                                                                                           Renewals
                                                                                                                                      rinnovi.mr.cms@aifa.gov.it
                                                                                                                                      rinnovi.mr.rms@aifa.gov.it
                 Submission of electronic versions of the    Agenzia Italiana del Farmaco
ITALY             responses to the list of questions for         Via del Tritone, 181                                                   s.petraglia@aifa.gov.it
                   applications referred to the CMDh              IT - 00187 Roma
                                                             Agenzia Italiana del Farmaco
                 Contact points for requests for variation
ITALY                                                            Via del Tritone, 181                   Laura Braghiroli                l.braghiroli@aifa.gov.it         0039 06 5978 4221
                           grouping numbers
                                                                  IT - 00187 Roma
                                                             Agenzia Italiana del Farmaco
                 Submission of paediatric information in
ITALY                                                            Via del Tritone, 181                                                  paediatrics@aifa.gov.it
                  member states - Articles 45 and 46
                                                                  IT - 00187 Roma



                                                                                                        Federico GALLO
                                                                                                      Massimo BIFARETTI         supportoamministrativo-pol@aifa.gov.it
                                                             Agenzia Italiana del Farmaco         Advice on method of payment
ITALY                  Address for advice on fees                Via del Tritone, 181
                                                                  IT - 00187 Roma
                                                                                                     Francesca CECCARINI                f.ceccarini@aifa.gov.it
                                                                                                    Advice on applicable fees




                                                             Agenzia Italiana del Farmaco
                                                                 Via del Tritone, 181
                                                                  IT - 00187 Roma

                                                                         and

                                                                  Ministry of Health                    Federico GALLO
ITALY                        Fees payable to                      Via G.Ribotta, 5                                              supportoamministrativo-pol@aifa.gov.it
                                                                    00144 Roma                        Massimo BIFARETTI




CMDh Compiled Contact Points                                                                CMDh/245/2011, Rev5, June 2012
                                                               State Agency of Medicines
                                                                    Jersikas iela 15                    Maija Cirkina            Maija.Cirkina@zva.gov.lv        00 371 67078429
LATVIA              Advice on MRP/DCP procedures                                                                                                                                   00 371 67078428
                                                                       LV – 1003                        Aija Stacevica           Aija.Stacevica@zva.gov.lv       00 371 67078464
                                                                          Riga




                                                               State Agency of Medicines
              Submission of new applications, variations and        Jersikas iela 15
LATVIA                                                                                                                               eCTD@zva.gov.lv
                               renewals                                LV – 1003
                                                                          Riga




                                                                                                                            MA applications MRP-DCP@zva.gov.lv
                                                               State Agency of Medicines
                                                                                                                                 Variations Variations_MRP-
              Submission of electronic response documents           Jersikas iela 15
LATVIA                                                                                                  Aija Stacevica                 DCP@zva.gov.lv            00 371 67078464   00 371 67078428
                     during MRP/DCP procedures                         LV – 1003
                                                                                                                                 Renewals Renewals_MRP-
                                                                          Riga
                                                                                                                                       DCP@zva.gov.lv
                                                               State Agency of Medicines
                 Submission of translations in MRP/DCP              Jersikas iela 15
LATVIA                                                                                                  Maija Cirkina        Translations_MRP-DCP@zva.gov.lv     00 371 67078429   00 371 67078428
                              procedures                               LV – 1003
                                                                          Riga
                                                               State Agency of Medicines
                 Submission of electronic versions of the
                                                                    Jersikas iela 15
LATVIA            responses to the list of questions for                                                Aija Stacevica       Responses_MRP-DCP@zva.gov.lv        00 371 67078464   00 371 67078428
                                                                       LV – 1003
                   applications referred to the CMDh
                                                                          Riga
                                                               State Agency of Medicines
                 Contact points for requests for variation          Jersikas iela 15
LATVIA                                                                                                 Inesa Mikulane            Inesa.Mikulane@zva.gov.lv       00 371 67078417   00 371 67078428
                           grouping numbers                            LV – 1003
                                                                          Riga
                                                               State Agency of Medicines
                 Submission of paediatric information in            Jersikas iela 15
LATVIA                                                                                                  Vita Gulevska              paediatric@zva.gov.lv         00 371 67078459   00 371 67078428
                  member states - Articles 45 and 46                   LV – 1003
                                                                          Riga




CMDh Compiled Contact Points                                                               CMDh/245/2011, Rev5, June 2012
                                                                              State Agency of Medicines
                                                                                   Jersikas iela 15
   LATVIA                 Address for advice on fees                                                                          Ludmila Lubnina             Ludmila.Lubnina@zva.gov.lv   00 371 67078428
                                                                                      LV – 1003
                                                                                         Riga




                                                                    State Agency of Medicines of Republic of Latvia
                                                                               (VAT) LV90001836181
                                                                   The TREASURY OF THE REPUBLIC OF LATVIA
   LATVIA                       Fees payable to                                                                                                                rekini@zva.gov.lv
                                                                     account number – LV63TREL2290650340000
                                                                               Code – BIC TRELLV22




                                                                                  Amt für Gesundheit
                                                                                    Äulestrasse 51
LIECHTENSTEIN          Advice on MRP/DCP procedures                                  P.O.Box 684                             Brigitte BATLINER                pharminfo@ag.llv.li      00 423 236 73 25    00 423 236 73 50
                                                                                    FL-9490 Vaduz
                                                                              Principality of Liechtenstein
                                                                                  Amt für Gesundheit
                                                                                    Äulestrasse 51
                    Submission of paediatric information in
LIECHTENSTEIN                                                                        P.O.Box 684                                                              pharminfo@ag.llv.li
                     member states - Articles 45 and 46
                                                                                    FL-9490 Vaduz
                                                                              Principality of Liechtenstein
                                                                                                                           Dovile ZACHARKIENE
                                                                                                                       (New applications and Renewals -    dovilezacharkiene@vvkt.lt   00 370 5 2639974
                                                                  State Medicines Control Agency under the Ministry of
                                                                                                                                  Validation)
                                                                          Health of the Republic of Lithuania
                                                                                                                           Audrone PETRIKIENE              audronepetrikiene@vvkt.lt   00 370 37 792 552
  LITHUANIA            Advice on MRP/DCP procedures                                Žirmūnų str. 139A                                                                                                       00 370 5 263 92 65
                                                                                                                       (New applications and Renewals -
                                                                                   LT-09120, Vilnius
                                                                                                                                 Responses)
                                                                                       Lithuania
                                                                                                                             Ruta BUCKIUNAITE               rutabuckiunaite@vvkt.lt    00 370 5 2639974
                                                                                                                                 (Variations)
                                                                  State Medicines Control Agency under the Ministry of
                                                                          Health of the Republic of Lithuania
                 Submission of new applications, variations and
  LITHUANIA                                                                        Žirmūnų str. 139A
                                  renewals
                                                                                   LT-09120, Vilnius
                                                                                       Lithuania




   CMDh Compiled Contact Points                                                                                  CMDh/245/2011, Rev5, June 2012
                                                                 State Medicines Control Agency under the Ministry of           MA applications
                                                                         Health of the Republic of Lithuania
                Submission of electronic response documents
 LITHUANIA                                                                        Žirmūnų str. 139A                               Variations                     response@vvkt.lt
                       during MRP/DCP procedures
                                                                                  LT-09120, Vilnius
                                                                                      Lithuania                                   Renewals
                                                                 State Medicines Control Agency under the Ministry of           MA applications
                                                                         Health of the Republic of Lithuania
                   Submission of translations in MRP/DCP
 LITHUANIA                                                                        Žirmūnų str. 139A                               Variations                    registracija@vvkt.lt
                                procedures
                                                                                  LT-09120, Vilnius
                                                                                      Lithuania                                   Renewals
                                                                 State Medicines Control Agency under the Ministry of
                   Submission of electronic versions of the              Health of the Republic of Lithuania
 LITHUANIA          responses to the list of questions for                        Žirmūnų str. 139A                                                             LoQ-CMD@vvkt.lt
                     applications referred to the CMDh                            LT-09120, Vilnius
                                                                                      Lithuania
                                                                 State Medicines Control Agency under the Ministry of
                                                                                                                                                     NeringaKalinauskaite@vvkt.lt (for national
                                                                         Health of the Republic of Lithuania
                   Contact points for requests for variation                                                                                                       variations)
 LITHUANIA                                                                        Žirmūnų str. 139A
                             grouping numbers                                                                                                          RutaBuckiunaite@vvkt.lt (for MR/DC
                                                                                  LT-09120, Vilnius
                                                                                                                                                                   variations)
                                                                                      Lithuania
                                                                 State Medicines Control Agency under the Ministry of
                                                                         Health of the Republic of Lithuania
                   Submission of paediatric information in
 LITHUANIA                                                                        Žirmūnų str. 139A                                                              paediatric@vvkt.lt
                    member states - Articles 45 and 46
                                                                                  LT-09120, Vilnius
                                                                                      Lithuania
 LITHUANIA               Address for advice on fees                                  www.vvkt.lt

                                                                            For all payers outside Lithuania:
                                                                 State Tax Inspectorate under Ministry of Finance of the
                                                                                 Republic of Lithuania
                                                                  Vasario 16-osios str. 15, LT-01514 Vilnius, Lithuania

                                                                     Correspondent Bank : DEUTSCHE BANK AG,
                                                                                     Frankfurt
                                                                                SWIFT: DEUTDEFF
 LITHUANIA                     Fees payable to
                                                                                  BLZ 500 700 10

                                                                          Beneficiary's Bank:“Swedbank”, AB
                                                                   Beneficiary‘s Bank address: Konstitucijos Av. 20A,
                                                                                         Vilnius
                                                                                  SWIFT: HABALT22
                                                                   Beneficiary's Acc. No LT24 7300 0101 1239 4300
                                                                                  Reference No. 5749

                                                                                  Direction de La Santé
                                                                                      Villa Louvigny
LUXEMBOURG            Advice on MRP/DCP procedures                   Division de la Pharmacie et des Medicaments           Jacqueline GENOUX-HAMES    Jacqueline.genoux-hames@ms.etat.lu          00 352 478 55 93   00 352 26 20 01 47
                                                                                      Allée Marconi
                                                                                  L- 2120 Luxembourg
                                                                                  Direction de La Santé
                                                                                      Villa Louvigny
                Submission of new applications, variations and
LUXEMBOURG                                                           Division de la Pharmacie et des Medicaments
                                 renewals
                                                                                      Allée Marconi
                                                                                  L- 2120 Luxembourg
                                                                                  Direction de La Santé                         MA applications
                                                                                      Villa Louvigny
                Submission of electronic response documents
LUXEMBOURG                                                           Division de la Pharmacie et des Medicaments                  Variations            The contact point for the procedure
                       during MRP/DCP procedures
                                                                                      Allée Marconi
                                                                                  L- 2120 Luxembourg                              Renewals




  CMDh Compiled Contact Points                                                                                    CMDh/245/2011, Rev5, June 2012
                                                                                                                          MA applications
                                                                                 Direction de La Santé
                                                                                     Villa Louvigny
                   Submission of translations in MRP/DCP
LUXEMBOURG                                                          Division de la Pharmacie et des Medicaments             Variations         Jacqueline.Genoux-Hames@ms.etat.lu
                                procedures
                                                                                     Allée Marconi
                                                                                 L- 2120 Luxembourg
                                                                                                                            Renewals
                                                                                 Direction de La Santé
                   Submission of electronic versions of the                          Villa Louvigny
LUXEMBOURG          responses to the list of questions for          Division de la Pharmacie et des Medicaments                                jacqueline.genoux-hames@ms.etat.lu
                     applications referred to the CMDh                               Allée Marconi
                                                                                 L- 2120 Luxembourg
                                                                                 Direction de La Santé
                                                                                     Villa Louvigny
                   Contact points for requests for variation
LUXEMBOURG                                                          Division de la Pharmacie et des Medicaments                                Jacqueline.Genoux-Hames@ms.etat.lu
                             grouping numbers
                                                                                     Allée Marconi
                                                                                 L- 2120 Luxembourg
                                                                                 Direction de La Santé
                                                                                     Villa Louvigny
                   Submission of paediatric information in
LUXEMBOURG                                                          Division de la Pharmacie et des Medicaments                                Jacqueline.Genoux-Hames@ms.etat.lu
                    member states - Articles 45 and 46
                                                                                     Allée Marconi
                                                                                 L- 2120 Luxembourg
                                                                                 Direction de La Santé
                                                                                     Villa Louvigny
LUXEMBOURG               Address for advice on fees                 Division de la Pharmacie et des Medicaments
                                                                                     Allée Marconi
                                                                                 L- 2120 Luxembourg



                                                                 Administration de l’Enregistrement et des Domaines
                                                                                 Plateau du St. Esprit
LUXEMBOURG                     Fees payable to
                                                                               L – 2010 LUXEMBURG
                                                                             Postal Account No. 77 33 70



                                                                                Medicines Authority
                                                                               Licensing Directorate
                                                                                                                                                                                                         00 356 23 43 9158
  MALTA               Advice on MRP/DCP procedures                              198 Rue D’Argens                           Helen VELLA                 helen.vella@gov.mt           00 356 23 43 91 10
                                                                                                                                                                                                         00 356 23 43 9161
                                                                                     GZR 03
                                                                                       Gzira



                                                                                Medicines Authority
                                                                               Licensing Directorate
                Submission of new applications, variations and
  MALTA                                                                      203 Level 3 Rue D’Argens                       Helen Vella                helen.vella@gov.mt            00356-23439149
                                 renewals                                                                                                                                                                00 356 23 43 9161
                                                                                    GZR 1368
                                                                                    Gzira Malta



                                                                                Medicines Authority                       MA applications
                                                                               Licensing Directorate
                Submission of electronic response documents
  MALTA                                                                         198 Rue D’Argens                            Variations                mrp-dcp.adm@gov.mt
                       during MRP/DCP procedures
                                                                                     GZR 03
                                                                                       Gzira                                Renewals
                                                                                Medicines Authority                       MA applications
                                                                               Licensing Directorate
                   Submission of translations in MRP/DCP
  MALTA                                                                         198 Rue D’Argens                            Variations                   Not applicable
                                procedures
                                                                                     GZR 03
                                                                                       Gzira                                Renewals




  CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                                            Medicines Authority
                     Submission of electronic versions of the              Licensing Directorate
    MALTA             responses to the list of questions for                 198 Rue D’Argens                                                        helen.vella@gov.mt
                       applications referred to the CMDh                          GZR 03
                                                                                   Gzira
                                                                            Medicines Authority
                                                                           Licensing Directorate
                     Contact points for requests for variation
    MALTA                                                                    198 Rue D’Argens                                                     Prelicensing.mru@gov.mt
                               grouping numbers
                                                                                  GZR 03
                                                                                   Gzira
                                                                            Medicines Authority
                                                                           Licensing Directorate
                     Submission of paediatric information in
    MALTA                                                                    198 Rue D’Argens                                                       melissa.borg@gov.mt
                      member states - Articles 45 and 46
                                                                                  GZR 03
                                                                                   Gzira
                                                                            Medicines Authority
                                                                           Accounts Department
    MALTA                  Address for advice on fees                    203 Level 3 Rue D’Argens             Steven Camilleri Nunns              prelicensing.mru@gov.mt               00356-23439179
                                                                                                                                                                                                         00 356 23 43 9161
                                                                                GZR 1368
                                                                                Gzira Malta

                                                                        Bank Details: HSBC Malta plc.
                                                                                  Gzira Branch
                                                                                    Malta
    MALTA                        Fees payable to                    Account Name: MEDICINES AUTHORITY         Steven Camilleri Nunns              prelicensing.mru@gov.mt               00356-23439180
                                                                                                                                                                                                         00 356 23 43 9161
                                                                      Account Number: 039-011176-002
                                                                 IBAN: MT78MMEB44392000000039011176002
                                                                           Swift Code: MMEBMTMT


                                                                                                            General advice on MRP/DCP
                                                                                                                    procedures:

                                                                                                            Kora DOORDUYN-VAN DER
                                                                                                                     STOEP
                                                                                                                                                  kh.doorduijn@cbg-meb.nl               0031882248065
                                                                                                                  (CMDh member)


                                                                                                                   Aimad TORQUI
                                                                                                                                                    a.torqui@cbg-meb.nl                 0031882248282
                                                                                                             (alternate CMDh member)
                                                                        Medicines Evaluation Board
                                                                        Graadt van Roggenweg 500
                                                                         NL-3503 RG UTRECHT
                                                                                                                                                      case@cbg-meb.nl
                                                                                                          Questions on specific MRP/DCP                                                                  003188 224 8001
THE NETHERLANDS         Advice on MRP/DCP procedures
                                                                                                                   procedures:
                                                                                                                                          The casenumber [xxxx] should be added in
                                                                              P.O. Box 8275
                                                                                                                                              the subjectheader of the e-mail. A
                                                                                                                                            casenumber is given to the applicant
                                                                                                                                          immediately after receipt of an application
                                                                                                                                               and should be used in all further
                                                                                                                                                       correspondence


                                                                                                             Herbal and homeopathic
                                                                                                                                                    e.v.galen@cbg-meb.nl
                                                                                                                    medicines
                                                                                                                                                                                        0031882248076
                                                                                                            Emiel VAN GALEN (Head of
                                                                                                           Pharmaco Therapeutic Group:
                                                                                                             Herbal and homeopathic
                                                                                                                    medicines)




    CMDh Compiled Contact Points                                                                     CMDh/245/2011, Rev5, June 2012
                                                                   Medicines Evaluation Board
                                                                   Graadt van Roggenweg 500
                                                                    NL-3503 RG UTRECHT
                  Submission of new applications, variations and
THE NETHERLANDS
                                   renewals
                                                                         P.O. Box 8275




                                                                   Medicines Evaluation Board                                                 case@cbg-meb.nl
                                                                   Graadt van Roggenweg 500
                                                                                                            MA applications
                                                                    NL-3503 RG UTRECHT                                           The casenumber [xxxx] should be added in
                  Submission of electronic response documents                                                                        the subjectheader of the e-mail. A
THE NETHERLANDS                                                                                               Variations
                         during MRP/DCP procedures                                                                                 casenumber is given to the applicant
                                                                         P.O. Box 8275                                           immediately after receipt of an application
                                                                                                              Renewals
                                                                                                                                      and should be used in all further
                                                                                                                                             correspondence.
                                                                   Medicines Evaluation Board                                                 case@cbg-meb.nl
                                                                   Graadt van Roggenweg 500
                                                                                                            MA applications
                                                                    NL-3503 RG UTRECHT                                           The casenumber [xxxx] should be added in
                     Submission of translations in MRP/DCP                                                                           the subjectheader of the e-mail. A
THE NETHERLANDS                                                                                               Variations
                                  procedures                                                                                       casenumber is given to the applicant
                                                                         P.O. Box 8275                                           immediately after receipt of an application
                                                                                                              Renewals
                                                                                                                                      and should be used in all further
                                                                                                                                             correspondence.

                                                                                                                                              case@cbg-meb.nl

                                                                                                                                 In addition to the information to be included
                                                                   Medicines Evaluation Board                                     in the subject of the e-mail (as mentioned
                                                                   Graadt van Roggenweg 500                                       on the top of the column),the casenumber
                                                                    NL-3503 RG UTRECHT                                                [xxx] should be added in the subject
                     Submission of electronic versions of the
                                                                                                                                       header of the e-mail, if known. The
THE NETHERLANDS       responses to the list of questions for
                                                                                                                                 casenumber is known if NL is RMS or CMS
                       applications referred to the CMDh
                                                                         P.O. Box 8275                                              in the particular procedure referred to
                                                                                                                                    CMD. If NL is not a RMS or CMS in the
                                                                                                                                  particular procedure referred to CMD, then
                                                                                                                                     the casenumber is not known by the
                                                                                                                                                    applicant




    CMDh Compiled Contact Points                                                                CMDh/245/2011, Rev5, June 2012
                                                                                                                                                No contact point. These procedure
                                                                                                                                             numbers can be requested via an e-form to
                                                                          Medicines Evaluation Board                                             be found on the MEB’s website:
                                                                          Graadt van Roggenweg 500
                                                                           NL-3503 RG UTRECHT                                                 http://www.cbg-meb.nl/CBG/en/human-
                     Contact points for requests for variation                                                                                           medicines/regulatory-
THE NETHERLANDS
                               grouping numbers                                                                                                      affairs/variations/default.htm
                                                                                 P.O. Box 8275
                                                                                                                                               under “More information on variations:
                                                                                                                                               Request variation number for grouped
                                                                                                                                             applications concerning more than one MA
                                                                                                                                                   and worksharing applications”
                                                                          Medicines Evaluation Board
                                                                          Graadt van Roggenweg 500                                           All applications must be accompanied by a
                                                                           NL-3503 RG UTRECHT                                                  cover letter. The documentation must be
                     Submission of paediatric information in                                                                                  submitted on CD or DVD. The cover letter
THE NETHERLANDS
                      member states - Articles 45 and 46                                                                                     and CDs or DVDs must be submitted to the
                                                                                 P.O. Box 8275                                                  address published on the MEB website
                                                                                                                                                            :www.cbg-meb.nl

                                                                          Medicines Evaluation Board
                                                                          Graadt van Roggenweg 500
                                                                           NL-3503 RG UTRECHT
THE NETHERLANDS            Address for advice on fees
                                                                                 P.O. Box 8275



                                                                   College ter beoordeling van geneesmiddelen
THE NETHERLANDS                  Fees payable to
                                                                                    UTRECHT

                                                                                                                    MRP and DCP procedures             CMS: MT@noma.no                   00 47 22 89 77 00   00 47 22 89 77 99
                                                                                                                                                       RMS: pk@noma.no
                                                                        The Norwegian Medicines Agency
    NORWAY              Advice on MRP/DCP procedures                          Sven Oftedalsvei 8
                                                                                                                        Inger Heggebø                inger.heggebo@noma.no               00 47 22 89 77 44
                                                                                 N-0950 Oslo
                                                                                                                      Sidsel Harby (CMS)               sidsel.harby@noma.no              00 47 22 89 77 29
                                                                                                                      Tove Bjerknes(RMS)              tove.bjerknes@noma.no              00 47 22 89 75 03
                                                                        The Norwegian Medicines Agency
                  Submission of new applications, variations and
    NORWAY                                                                    Sven Oftedalsvei 8
                                   renewals
                                                                                 N-0950 Oslo
                                                                                                                        MA applications
                                                                        The Norwegian Medicines Agency
                  Submission of electronic response documents                                                                                          CMS: MT@noma.no
    NORWAY                                                                    Sven Oftedalsvei 8                          Variations
                         during MRP/DCP procedures                                                                                                     RMS: pk@noma.no
                                                                                 N-0950 Oslo
                                                                                                                          Renewals
                                                                                                                        MA applications
                                                                        The Norwegian Medicines Agency
                     Submission of translations in MRP/DCP
    NORWAY                                                                    Sven Oftedalsvei 8                          Variations                       PI@noma.no
                                  procedures
                                                                                 N-0950 Oslo
                                                                                                                          Renewals
                     Submission of electronic versions of the           The Norwegian Medicines Agency
                                                                                                                                                       CMS: MT@noma.no
    NORWAY            responses to the list of questions for                  Sven Oftedalsvei 8
                                                                                                                                                       RMS: pk@noma.no
                       applications referred to the CMDh                         N-0950 Oslo
                                                                        The Norwegian Medicines Agency
                     Contact points for requests for variation
    NORWAY                                                                    Sven Oftedalsvei 8                                                           pk@noma.no
                               grouping numbers
                                                                                 N-0950 Oslo
                                                                        The Norwegian Medicines Agency
                     Submission of paediatric information in
    NORWAY                                                                    Sven Oftedalsvei 8                                                         PDCO@noma.no
                      member states - Articles 45 and 46
                                                                                 N-0950 Oslo
                                                                        The Norwegian Medicines Agency
    NORWAY                 Address for advice on fees                         Sven Oftedalsvei 8                                                          MT@noma.no
                                                                                 N-0950 Oslo



    CMDh Compiled Contact Points                                                                            CMDh/245/2011, Rev5, June 2012
                                                                             Statens legemiddelverk
                                                                               Sven Oftedals vei 8
                                                                                 NO-0950 OSLO
                                                                               Tel: 47 22 89 77 00
                                                                                Den Norske Bank
NORWAY                       Fees payable to
                                                                             P.O.Box 1171, Sentrum
                                                                                 NO-0107 Oslo
                                                                        Bank account no.: 7694 05 00903
                                                                              SWIFT: DNBANOKK
                                                                          IBAN nr NO71 7694 05 00903

                                                                                                                              Anna Kalita
                                                                                                                                                        anna.kalita@urpl.gov.pl            00 48 22 492 13 30
                                                                                                                          Andrzej Czesławski                                                                    00 48 22 492 13 69
                                                                                                                           (New Application)
                                                               Office for Registration of Medicinal Products, Medical                                andrzej.czeslawski@urpl.gov.pl        00 48 22 492 13 70
                                                                                                                                                                                                                00 48 22 492 13 69
                                                                           Devices and Biocidal Products
POLAND              Advice on MRP/DCP procedures                                                                               Jolanta Maj
                                                                                 41 Zabkowska Str.                                                      jolanta.maj@urpl.gov.pl            00 4822 492 13 62
                                                                                                                         Krystyna Sieduszewska                                                                  00 48 22 492 13 69
                                                                              03-736 Warsaw, Poland                                               krystyna.sieduszewska@urpl.gov.pl        00 4822 492 13 57
                                                                                                                               (Variations)
                                                                                                                                                                                                                00 48 22 492 13 69
                                                                                                                                                  agnieszka.barcikowska@urpl.gov.pl        00 4822 492 13 60
                                                                                                                         Agnieszka Barcikowska
                                                                                                                              (Renewals)
                                                               Office for Registration of Medicinal Products, Medical
              Submission of new applications, variations and               Devices and Biocidal Products
POLAND
                               renewals                                          41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland
                                                                                                                            MA applications               mrp.dcp@urpl.gov.pl
                                                               Office for Registration of Medicinal Products, Medical
              Submission of electronic response documents                  Devices and Biocidal Products
POLAND                                                                                                                         Variations                variations@urpl.gov.pl
                     during MRP/DCP procedures                                   41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland
                                                                                                                              Renewals                   renewals@urpl.gov.pl
                                                                                                                            MA applications               mrp.dcp@urpl.gov.pl
                                                               Office for Registration of Medicinal Products, Medical
                 Submission of translations in MRP/DCP                     Devices and Biocidal Products
POLAND                                                                                                                         Variations                variations@urpl.gov.pl
                              procedures                                         41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland
                                                                                                                               Renewals                  renewals@urpl.gov.pl
                                                                                                                                                          mrp.dcp@urpl.gov.pl
                                                                                                                            MA applications
                                                               Office for Registration of Medicinal Products, Medical
                 Submission of electronic versions of the                                                                                                variations@urpl.gov.pl
                                                                           Devices and Biocidal Products                       Variations
POLAND            responses to the list of questions for
                                                                                 41 Zabkowska Str.
                   applications referred to the CMDh                                                                                             (Copy to the personal E-mail address of
                                                                              03-736 Warsaw, Poland
                                                                                                                                                     the contact person, if known, is
                                                                                                                                                             recommended)
                                                               Office for Registration of Medicinal Products, Medical
                 Contact points for requests for variation                 Devices and Biocidal Products
POLAND                                                                                                                                                   variations@urpl.gov.pl
                           grouping numbers                                      41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland
                                                               Office for Registration of Medicinal Products, Medical
                 Submission of paediatric information in                   Devices and Biocidal Products
POLAND                                                                                                                                               dane.pediatryczne@urpl.gov.pl
                  member states - Articles 45 and 46                             41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland
                                                               Office for Registration of Medicinal Products, Medical
                                                                           Devices and Biocidal Products
POLAND                 Address for advice on fees                                                                           MRP Variations             oplaty.zmiany@urpl.gov.pl
                                                                                 41 Zabkowska Str.
                                                                              03-736 Warsaw, Poland

                                                                                    Bank:
                                                                             Narodowy Bank Polski
                                                                Plac Powstańców Warszawy 4, 00-950 Warszawa,
POLAND                       Fees payable to
                                                                                   POLAND
                                                               Account No.: PL30 1010 1010 0094 1022 3100 0000
                                                                          NBP BIC Code: NBPLPLPW



CMDh Compiled Contact Points                                                                                    CMDh/245/2011, Rev5, June 2012
                                                                                                                         Marta MARCELINO
                                                                INFARMED - Autoridade Nacional do Medicamento
                                                                                                                         (New Applications)
                                                                            e Produtos de Saúde, I.P.
PORTUGAL             Advice on MRP/DCP procedures                                                                                                             dam@infarmed.pt              00 351 21 798 7234   00 351 21 7987255
                                                                Parque de Saúde de Lisboa - Avenida do Brasil, 53
                                                                                                                         Margarida OLIVEIRA
                                                                           1749-004 Lisboa - Portugal
                                                                                                                       (Variations & Renewals)



                                                                                                                                                     PT= RMS: rms.procedures@infarmed.pt
                                                                                                                    DAM - Direcção de Avaliação de
                                                                INFARMED - Autoridade Nacional do Medicamento
                                                                                                                      Medicamentos (Medicines
               Submission of new applications, variations and               e Produtos de Saúde, I.P.                                                     MA applications PT= CMS:
PORTUGAL                                                                                                              Evaluation Department) for                                           (351) 21 798 7234    (351) 21 798 7255
                                renewals                        Parque de Saúde de Lisboa - Avenida do Brasil, 53                                        cms.procedures@infarmed.pt
                                                                                                                     MA applications, Variations,
                                                                           1749-004 Lisboa - Portugal
                                                                                                                              Renewals
                                                                                                                                                           Other: dam@infarmed.pt


                                                                                                                                                                  PT, RMS:
                                                                                                                                                               rms@infarmed.pt
                                                                                                                           MA applications
                                                                INFARMED - Autoridade Nacional do Medicamento
               Submission of electronic response documents                  e Produtos de Saúde, I.P.                                                      MA applications PT, CMS:
PORTUGAL                                                                                                                      Variations
                      during MRP/DCP procedures                 Parque de Saúde de Lisboa - Avenida do Brasil, 53                                             cms@infarmed.pt
                                                                           1749-004 Lisboa - Portugal
                                                                                                                              Renewals
                                                                                                                                                                  Other:
                                                                                                                                                              dam@infarmed.pt
                                                                                                                                                                  PT, RMS:
                                                                                                                                                               rms@infarmed.pt
                                                                                                                           MA applications
                                                                INFARMED - Autoridade Nacional do Medicamento
                  Submission of translations in MRP/DCP                     e Produtos de Saúde, I.P.                                                      MA applications PT, CMS:
PORTUGAL                                                                                                                      Variations
                               procedures                       Parque de Saúde de Lisboa - Avenida do Brasil, 53                                             cms@infarmed.pt
                                                                           1749-004 Lisboa - Portugal
                                                                                                                              Renewals
                                                                                                                                                                  Other:
                                                                                                                                                              dam@infarmed.pt
                                                                                                                                                                  PT, RMS:
                                                                                                                                                               rms@infarmed.pt
                                                                INFARMED - Autoridade Nacional do Medicamento
                  Submission of electronic versions of the
                                                                            e Produtos de Saúde, I.P.                                                      MA applications PT, CMS:
PORTUGAL           responses to the list of questions for
                                                                Parque de Saúde de Lisboa - Avenida do Brasil, 53                                             cms@infarmed.pt
                    applications referred to the CMDh
                                                                           1749-004 Lisboa - Portugal
                                                                                                                                                                  Other:
                                                                                                                                                              dam@infarmed.pt

                                                                INFARMED - Autoridade Nacional do Medicamento
                                                                                                                      Direcção de Avaliação de                    PT, RMS:
                  Contact points for requests for variation                 e Produtos de Saúde, I.P.
PORTUGAL                                                                                                              Medicamentos (Medicines
                            grouping numbers                    Parque de Saúde de Lisboa - Avenida do Brasil, 53
                                                                                                                       Evaluation Department)                  rms@infarmed.pt
                                                                           1749-004 Lisboa - Portugal



                                                                INFARMED - Autoridade Nacional do Medicamento
                  Submission of paediatric information in                   e Produtos de Saúde, I.P.
PORTUGAL                                                                                                                                                      dam@infarmed.pt
                   member states - Articles 45 and 46           Parque de Saúde de Lisboa - Avenida do Brasil, 53
                                                                           1749-004 Lisboa - Portugal




                                                                INFARMED - Autoridade Nacional do Medicamento
                                                                            e Produtos de Saúde, I.P.                CIMI - Centro de Informação
PORTUGAL                Address for advice on fees                                                                                                      centro.informacao@infarmed.pt      (351) 21 798 7373    (351) 21 798 7316
                                                                Parque de Saúde de Lisboa - Avenida do Brasil, 53       (Information Centre)
                                                                           1749-004 Lisboa - Portugal




 CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                                                    INFARMED
                                                                            NIB 078101120000000624751
   PORTUGAL                      Fees payable to
                                                                         IBAN PT50078101120000000624751
                                                                              SWIFT CODE IGCPPTPL




                                                                   National Agency for Medicines and Medical Devices      Ada Alexandra Georgescu
                                                                                                                                                           ada.georgescu@anm.ro
                                                                                   48, Av. Sanatescu                          (CMDh Member)
   ROMANIA              Advice on MRP/DCP procedures                                                                                                                                   00 40 21 316 10 79   00 40 21 316 34 97
                                                                                   011478 Bucharest
                                                                                                                                                           nadia.grigoras@anm.ro
                                                                                        Romania                        Nadia Grigoras (CMDh Alternate)

                                                                   National Agency for Medicines and Medical Devices
                                                                                                                                                         mrp-dcp.responses@anm.ro
                  Submission of new applications, variations and                   48, Av. Sanatescu
   ROMANIA
                                   renewals                                        011478 Bucharest
                                                                                                                                                           var.responses@anm.ro
                                                                                        Romania

                                                                   National Agency for Medicines and Medical Devices           MA applications
                                                                                                                                                         mrp-dcp.responses@anm.ro
                  Submission of electronic response documents                      48, Av. Sanatescu                             Renewals
   ROMANIA
                         during MRP/DCP procedures                                 011478 Bucharest
                                                                                                                                                           var.responses@anm.ro
                                                                                        Romania                                  Variations

                                                                   National Agency for Medicines and Medical Devices           MA applications
                                                                                                                                                         mrp-dcp.translations@anm.ro
                     Submission of translations in MRP/DCP                         48, Av. Sanatescu                             Renewals
   ROMANIA
                                  procedures                                       011478 Bucharest
                                                                                                                                                           var.translation@anm.ro
                                                                                        Romania                                  Variations

                                                                   National Agency for Medicines and Medical Devices      Ada Alexandra Georgescu
                     Submission of electronic versions of the                                                                                              ada.georgescu@anm.ro
                                                                                   48, Av. Sanatescu                          (CMDh Member)
   ROMANIA            responses to the list of questions for
                                                                                   011478 Bucharest
                       applications referred to the CMDh                                                                                                   nadia.grigoras@anm.ro
                                                                                        Romania                        Nadia Grigoras (CMDh Alternate)

                                                                   National Agency for Medicines and Medical Devices
                     Contact points for requests for variation                     48, Av. Sanatescu
   ROMANIA                                                                                                                                                  mrp-dcp.info@anm.ro
                               grouping numbers                                    011478 Bucharest
                                                                                        Romania

                                                                   National Agency for Medicines and Medical Devices
                     Submission of paediatric information in                       48, Av. Sanatescu
   ROMANIA                                                                                                                                                 paediatric.info@anm.ro
                      member states - Articles 45 and 46                           011478 Bucharest
                                                                                        Romania

                                                                             State Institute for Drug Control
                                                                                        Kvetná 11
SLOVAK REPUBLIC         Advice on MRP/DCP procedures                                                                         Mária POLLÁKOVÁ                  pollakova@sukl.sk        00 421 2 5070 1103   00 421 2 5557 1105
                                                                                      SK – 825 08
                                                                                      Bratislava 26




    CMDh Compiled Contact Points                                                                                CMDh/245/2011, Rev5, June 2012
                                                                              State Institute for Drug Control
                                                                                         Kvetná 11
                  Submission of new applications, variations and
SLOVAK REPUBLIC                                                                         SK – 825 08
                                   renewals
                                                                                       Bratislava 26
                                                                                      Slovak Republic




                                                                                                                             MA applications
                                                                              State Institute for Drug Control
                  Submission of electronic response documents                            Kvetná 11
SLOVAK REPUBLIC                                                                                                                Variations         eu.registracia@sukl.sk
                         during MRP/DCP procedures                                     SK – 825 08
                                                                                       Bratislava 27
                                                                                                                               Renewals
                                                                                                                             MA applications
                                                                              State Institute for Drug Control
                     Submission of translations in MRP/DCP                               Kvetná 11
SLOVAK REPUBLIC                                                                                                                Variations         eu.registracia@sukl.sk
                                  procedures                                           SK – 825 08
                                                                                       Bratislava 28
                                                                                                                               Renewals
                                                                              State Institute for Drug Control
                     Submission of electronic versions of the
                                                                                         Kvetná 11
SLOVAK REPUBLIC       responses to the list of questions for                                                                                      eu.registracia@sukl.sk
                                                                                       SK – 825 08
                       applications referred to the CMDh
                                                                                       Bratislava 29
                                                                              State Institute for Drug Control
                     Contact points for requests for variation                           Kvetná 11
SLOVAK REPUBLIC                                                                                                                                    registracia@sukl.sk
                               grouping numbers                                        SK – 825 08
                                                                                       Bratislava 31
                                                                              State Institute for Drug Control
                     Submission of paediatric information in                             Kvetná 11
SLOVAK REPUBLIC                                                                                                                                    paediatric@sukl.sk
                      member states - Articles 45 and 46                               SK – 825 08
                                                                                       Bratislava 30
                                                                              State Institute for Drug Control
                                                                                Department of registration
SLOVAK REPUBLIC            Address for advice on fees                                    Kvetná 11                                                 registracia@sukl.sk
                                                                                       SK – 825 08
                                                                                       Bratislava 26

                                                                   The bank account (payment from foreign countries):
                                                                          IBAN: SK3481800000007000133673
                                                                               SWIFT (BIC): SUBASKBX
                                                                         The bank account (domestic payment):
SLOVAK REPUBLIC                  Fees payable to                                  7000133673/8180

                                                                                  constant symbol: 0558
                                                                   variable symbol: application number (SIDC reference
                                                                                         number)




    CMDh Compiled Contact Points                                                                                 CMDh/245/2011, Rev5, June 2012
                                                                                                                            Sabina ZALAR
                                                                                                                           (CMDh Member)

                                                                                                                     Ana VIDENSEK PODGORELEC
                                                             Agency for Medicinal Products and Medical Devices of                                                        00 386 8 2000 500
                                                                                                                         (CMDh Alternate & new
                                                                          the Republic of Slovenia
                                                                                                                         MRP/DCP applications)
SLOVENIA             Advice on MRP/DCP procedures                               Ptujska ulica 21                                                   mrp_dcp@jazmp.si      00 386 8 2000 554   00 386 8 2000 510
                                                                                    SI-1000
                                                                                                                            Marko VITAS
                                                                              Ljubljana, Slovenia                                                                        00 386 8 2000 556
                                                                                                                      (new MRP/DCP applications)

                                                                                                                     Ana VIDENSEK PODGORELEC
                                                                                                                         (renewals & variations)

                                                              Agency for Medicinal Products and Medical Devices of
                                                                           the Republic of Slovenia
               Submission of new applications, variations and
SLOVENIA                                                                         Ptujska ulica 21                                                  mrp_dcp@jazmp.si
                                 renewals
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia
                                                              Agency for Medicinal Products and Medical Devices of         MA applications
                                                                           the Republic of Slovenia
               Submission of electronic response documents
SLOVENIA                                                                         Ptujska ulica 21                             Variations           mrp_dcp@jazmp.si
                      during MRP/DCP procedures
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia                           Renewals
                                                              Agency for Medicinal Products and Medical Devices of         MA applications
                                                                           the Republic of Slovenia
                  Submission of translations in MRP/DCP
SLOVENIA                                                                         Ptujska ulica 21                             Variations           mrp_dcp@jazmp.si
                                procedures
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia                            Renewals
                                                              Agency for Medicinal Products and Medical Devices of
                  Submission of electronic versions of the                 the Republic of Slovenia
SLOVENIA           responses to the list of questions for                        Ptujska ulica 21                                                  mrp_dcp@jazmp.si
                    applications referred to the CMDh                                SI-1000
                                                                               Ljubljana, Slovenia
                                                              Agency for Medicinal Products and Medical Devices of
                                                                           the Republic of Slovenia
                  Contact points for requests for variation
SLOVENIA                                                                         Ptujska ulica 21                                                  mrp_dcp@jazmp.si
                            grouping numbers
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia
                                                              Agency for Medicinal Products and Medical Devices of
                                                                           the Republic of Slovenia
                  Submission of paediatric information in
SLOVENIA                                                                         Ptujska ulica 21                                                  paediatric@jazmp.si
                   member states - Articles 45 and 46
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia
                                                              Agency for Medicinal Products and Medical Devices of
                                                                           the Republic of Slovenia
SLOVENIA                Address for advice on fees                               Ptujska ulica 21                                                  mrp_dcp@jazmp.si
                                                                                     SI-1000
                                                                               Ljubljana, Slovenia




 CMDh Compiled Contact Points                                                                               CMDh/245/2011, Rev5, June 2012
                                                                             Bank name: Banka Slovenije
                                                                            Branch address: Slovenska 35
                                                                                 Town/City: Ljubljana
                                                                                   Post code: 1505
                                                                         Account number: 01100-6000020296
                                                                Ref. No: 00 760002-400 (Application fees for medicinal
                                                                  products for human use; if the payment is made in
SLOVENIA                      Fees payable to                                         Slovenia)

                                                                Ref. No: 00 760102-400 (Application fees for medicinal
                                                                 products for human use; if the payment is made from
                                                                                      abroad)

                                                                            IBAN: SI56011006000020296
                                                                               SWIFT code: BSLJSI2X



                                                                                                                         Maria Luisa García-Vaquero
                                                                                                                              (CMDh Member)
                                                                                                                                                           mgarciav@aemps.es        00 34 91 822 50 47   00 34 91 822 50 43
                                                                                                                              Laura Oliveira
                                                                                                                           (CMDh Alternate &new
                                                                   Agencia Española del Medicamento y Productos            MRP/DCP applications)            loliveira@aemps.es      00 34 91 822 51 42   00 34 91 822 50 43
                                                                                    Sanitarios
                                                                         Parque Empresarial Las Mercedes                      Carmen Serradilla
 SPAIN               Advice on MRP/DCP procedures                                    Edificio 8                          (new MRP/DCP applications)        cserradilla@aemps.es     00 34 91 822 51 54   00 34 91 822 50 43
                                                                                  C/Campezo 1,
                                                                                  28022 Madrid                             Cristina Rodríguez Rojas
                                                                                      España                                (renewals & variations)       crodriguezr@aemps.es      00 34 91 822 58 11   00 34 91 822 50 43

                                                                                                                         Lola Martín de Santa-Olalla y
                                                                                                                                    Llanes                   lmsll@aemps.es         00 34 91 822 51 95   00 34 91 822 50 43
                                                                                                                            (Worksharing variation
                                                                                                                                procedures )


                                                                   Agencia Española del Medicamento y Productos
                                                                                    Sanitarios
                                                                         Parque Empresarial Las Mercedes
               Submission of new applications, variations and
 SPAIN                                                                               Edificio 8
                                renewals
                                                                                  C/Campezo 1,
                                                                                  28022 Madrid
                                                                                      España
                                                                   Agencia Española del Medicamento y Productos
                                                                                    Sanitarios                                 MA applications             eudramrna@aemps.es
                                                                         Parque Empresarial Las Mercedes
               Submission of electronic response documents
 SPAIN                                                                               Edificio 8                                   Variations             eudramrve@es-v.eudra.org
                      during MRP/DCP procedures
                                                                                  C/Campezo 1,
                                                                                  28022 Madrid                                    Renewals               eudramrve@es-v.eudra.org
                                                                                      España
                                                                   Agencia Española del Medicamento y Productos
                                                                                    Sanitarios                                 MA applications           maapplications@aemps.es
                                                                         Parque Empresarial Las Mercedes
                  Submission of translations in MRP/DCP
 SPAIN                                                                               Edificio 8                                   Variations             eudramrve@es-v.eudra.org
                               procedures
                                                                                  C/Campezo 1,
                                                                                  28022 Madrid                                    Renewals               eudramrve@es-v.eudra.org
                                                                                      España
                                                                   Agencia Española del Medicamento y Productos
                                                                                    Sanitarios
                  Submission of electronic versions of the               Parque Empresarial Las Mercedes
 SPAIN             responses to the list of questions for                            Edificio 8                                                            eudramrna@aemps.es
                    applications referred to the CMDh                             C/Campezo 1,
                                                                                  28022 Madrid
                                                                                      España


 CMDh Compiled Contact Points                                                                                   CMDh/245/2011, Rev5, June 2012
                                                                 Agencia Española del Medicamento y Productos
                                                                                  Sanitarios
                                                                       Parque Empresarial Las Mercedes                      Laura Oliveira                  loliveira@aemps.es
                 Contact points for requests for variation
SPAIN                                                                              Edificio 8
                           grouping numbers
                                                                                C/Campezo 1,                              Carmen Serradilla                cserradilla@aemps.es
                                                                                28022 Madrid
                                                                                    España
                                                                 Agencia Española del Medicamento y Productos
                                                                                  Sanitarios
                                                                       Parque Empresarial Las Mercedes
                 Submission of paediatric information in
SPAIN                                                                              Edificio 8                                                       medicamentos_pediatricos@aemps.es
                  member states - Articles 45 and 46
                                                                                C/Campezo 1,
                                                                                28022 Madrid
                                                                                    España
                                                                 Agencia Española del Medicamento y Productos
                                                                                  Sanitarios
                                                                       Parque Empresarial Las Mercedes
SPAIN                  Address for advice on fees                                  Edificio 8
                                                                                C/Campezo 1,
                                                                                28022 Madrid
                                                                                    España


                                                                  Agencia Española de Medicamentos y Productos
                                                                                 Sanitarios ( AEMPS)
                                                               The bank account is opened in the name of AEMPS in
                                                                                    BBVA, number:
SPAIN                        Fees payable to
                                                                             0182 2370 46 020397751 6
                                                                (International bank account code and number: IBAN
                                                                         ES27 0182 2370 4602 0397 7516).
                                                                            Swift / BIC: BBVAESMMXXX


                                                                                                                       Mr. Christer BACKMAN
                                                                                                                                                         christer.backman@mpa.se        00 46 18 17 26 19
                                                                                                                          (CMDh Member)

                                                                                                                       Ms. Christin OLOFSSON
                                                                                                                                                         christin.olofsson@mpa.se       00 46 18 17 26 71
                                                                                                                          (CMDh Alternate)

                                                                                                                          Mrs. Ann BYLUND
                                                                                                                                                           ann.bylund@mpa.se            00 46 18 17 42 40
                                                                                                                            (DCP - RMS)

                                                                            Medical Products Agency                    Mrs. Alenoosh Abedi
                                                                                                                                                         Alenoosh.abedi@mpa.se          00 46 18 17 46 97
SWEDEN              Advice on MRP/DCP procedures                           Dag Hammarskjölds väg 42                 (MRP new applications - RMS)                                                            00 46 18 50 55 44
                                                                             S - 751 03 UPPSALA
                                                                                                                       Mrs. Catarina WALLÉN
                                                                                                                                                          catarina.wallen@mpa.se        00 46 18 17 42 04
                                                                                                                    (DCP & MRP new applications -
                                                                                                                               CMS)
                                                                                                                                                          jenny.daniels@mpa.se          00 46 18 17 42 91
                                                                                                                         Ms. Jenny DANIELS
                                                                                                                             (Variations)
                                                                                                                                                         adam.andersson@mpa.se          00 46 18 17 42 41
                                                                                                                       Mr. Adam ANDERSSON
                                                                                                                             (Renewals)


                                                                            Medical Products Agency
              Submission of new applications, variations and
SWEDEN                                                                     Dag Hammarskjölds väg 42
                               renewals
                                                                             S - 751 03 UPPSALA

                                                                                                                           MA applications
                                                                            Medical Products Agency
              Submission of electronic response documents
SWEDEN                                                                     Dag Hammarskjölds väg 42                          Variations                       RIC@mpa.se
                     during MRP/DCP procedures
                                                                             S - 751 03 UPPSALA
                                                                                                                              Renewals


CMDh Compiled Contact Points                                                                               CMDh/245/2011, Rev5, June 2012
                                                                                                                          MA applications
                                                                           Medical Products Agency
                     Submission of translations in MRP/DCP
   SWEDEN                                                                 Dag Hammarskjölds väg 42                           Variations                          RIC@mpa.se
                                  procedures
                                                                            S - 751 03 UPPSALA
                                                                                                                             Renewals
                     Submission of electronic versions of the              Medical Products Agency
   SWEDEN             responses to the list of questions for              Dag Hammarskjölds väg 42                                                               RIC@mpa.se
                       applications referred to the CMDh                      S - 751 03 UPPSALA
                                                                           Medical Products Agency
                     Contact points for requests for variation
   SWEDEN                                                                 Dag Hammarskjölds väg 42                                                               RIC@mpa.se
                               grouping numbers
                                                                              S - 751 03 UPPSALA
                                                                           Medical Products Agency
                     Submission of paediatric information in
   SWEDEN                                                                 Dag Hammarskjölds väg 42                                                        paediatric.studies@mpa.se
                      member states - Articles 45 and 46
                                                                              S - 751 03 UPPSALA
                                                                           Medical Products Agency
                                                                   Registration and Information Management
   SWEDEN                  Address for advice on fees                                                                                                            RIC@mpa.se                   00 46 18 17 46 00    00 46 18 54 85 66
                                                                                     Box 26
                                                                              S - 751 03 UPPSALA


   SWEDEN                        Fees payable to


                                                                 Medicines and Healthcare products Regulatory      Regulatory Information Service
                                                                                   Agency                               or Lorraine GEEAR            mr-dcprocedures@mhra.gsi.gov.uk or
                                                                                                                                                                                             00 44 0203 080 6709
UNITED KINGDOM          Advice on MRP/DCP procedures                    151 Buckingham Palace Road                                                    saadia.sharief@mhra.gsi.gov.uk or
                                                                                                                                                                                             00 44 0203 080 7400
                                                                             London SW1W 9SZ                             Saadia SHARIEF                   RIS.NA@mhra.gsi.gov.uk
                                                                                                                                                                                             00 44 0203 080 6951
                                                                               United Kingdom                        (MR renewals and PSURs)



                                                                    Area 4 Information Processing Unit MHRA 151                                     Submissions.centre@mhra.gsi.gov.uk
                  Submission of new applications, variations and
UNITED KINGDOM                                                   Buckingham Palace Road London SW1W 9SZ United                                        (For contact only - not receipt of
                                   renewals
                                                                                      Kingdom                                                                 documentation)


                                                                 Medicines and Healthcare products Regulatory
                                                                                   Agency
                  Submission of electronic response documents
UNITED KINGDOM                                                          151 Buckingham Palace Road                                                    MR-DCprocedures@mhra.gsi.gov.uk
                         during MRP/DCP procedures
                                                                             London SW1W 9SZ
                                                                               United Kingdom

                                                                 Medicines and Healthcare products Regulatory
                                                                                   Agency
                     Submission of translations in MRP/DCP
UNITED KINGDOM                                                          151 Buckingham Palace Road
                                  procedures
                                                                             London SW1W 9SZ
                                                                               United Kingdom
                                                                 Medicines and Healthcare products Regulatory
                     Submission of electronic versions of the                      Agency                                                           MR-DCprocedures@mhra.gsi.gov.uk
UNITED KINGDOM        responses to the list of questions for            151 Buckingham Palace Road
                       applications referred to the CMDh                     London SW1W 9SZ                                                         (or transmission via Eudralink to uk-
                                                                               United Kingdom                                                               h.cmd is recommended)
                                                                 Medicines and Healthcare products Regulatory
                                                                                   Agency
                     Contact points for requests for variation
UNITED KINGDOM                                                          151 Buckingham Palace Road                                                   mr-dcprocedures@mhra.gsi.gov.uk
                               grouping numbers
                                                                             London SW1W 9SZ
                                                                               United Kingdom
                                                                 Medicines and Healthcare products Regulatory
                                                                                    Agency
                                                                               Paediatric Studies
                     Submission of paediatric information in
UNITED KINGDOM                                                            Information Processing Unit                                                paediatricstudies@mhra.gsi.gov.uk
                      member states - Articles 45 and 46
                                                                        151 Buckingham Palace Road
                                                                              London SW1W 9SZ
                                                                                United Kingdom



    CMDh Compiled Contact Points                                                                             CMDh/245/2011, Rev5, June 2012
                                                                 Policy, MHRA, 151 Buckingham Palace Road,   Kirsten Hubble, Karen Salawu
UNITED KINGDOM              Address for advice on fees                                                                                                                        00 44 0203 080 6000
                                                                      London SW1W 9SZ United Kingdom                 or Sue Jones
                                                                              For All Payments
                                                                                 Citibank N.A.
                                                                               London Branch
                                                                             25 Canada Square,
                                                                                                                     The Cashiers
                                                                                Canary Wharf
                                                                                                                         MHRA
                                                                              London, E14 5LB
                                                                                                              5th Floor, 151 Buckingham
UNITED KINGDOM                   Fees payable to                                      UK                                                       cashiers@mhra.gsi.gov.uk       00 44 0203 080 6000
                                                                                                             Palace Road, London SW1W
                                                                            Sort Code 08 33 00
                                                                                                                          9SZ
                                                                          Account number 12314800
                                                                                                                    United Kingdom
                                                                         Account Name GBS re MHRA
                                                                            Swift Code CITIGB2L
                                                                       IBAN GB05CITI08330012314800
                                                                     Reference: Invoice Number and/or Ac
                                                                         European Medicines Agency
                      Submission of electronic versions of the               7 Westferry Circus
   EUROPEAN
                       responses to the list of questions for                  Canary Wharf                                                 H-CMDhSecretariat@ema.europa.eu
MEDICINES AGENCY
                        applications referred to the CMDh                         London
                                                                                 E14 4HB
   EUROPEAN
                         Advice on MRP/DCP procedures                                                              Barbara MENTRE             barbara.mentre@ec.europa.eu       00 32 2298 4000
  COMMISSION




     CMDh Compiled Contact Points                                                                     CMDh/245/2011, Rev5, June 2012
" column.

              COMMENTS




     Preferably electronic submission
      [eCTD/Non eCTD electronical
           Submission (NeeS)].
     Requested paper copies for each
           application (strength,
        pharmaceutical form etc.):
      AT = CMS/RMS/pure national:
       cover letter, application form




            CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
        Method of payment:
Only on postal account - please be
 aware that banks will charge you
for transactions fees, cheques are
            not accepted.
  The invoice number, the client
   number and the name of the
      product must be stated.
No fees should be paid in advance
         of the submission.




     For all mutual recognition,
     decentralised and national
   applications, ONLY electronic
     submission is ACCEPTED.
All recommendations on electronic
    submission can be found on
         following websites:
           http://www.fagg-
afmps.be/nl/MENSELIJK_gebruik/g
eneesmiddelen/geneesmiddelen/pr
    ocedures_vhb/esubmission/
           http://www.fagg-
afmps.be/en/human_use/medicines
/Medicines/MA_procedures/esubmi
                 ssion/




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
Information of fees can be found on
       the following website:
          http://www.fagg-
      afmps.be/en/items/fees/


       Method of Payment
  Only on the postal account, in
  EUROs (please be aware that
    banks will charge you for
       transactions fees).
   Cheques are not accepted
The name of the applicant and the
  name of the product must be
             stated.
 Proof of payment is required in
module 1 before an application can
          be accepted.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
      Proof of payment should
accompany the application. Please
be aware that banks will charge you
 for transactions fees. Information
    on fees can be found on the
          following website:
http://en.bda.bg/index.php?option=
com_content&view=category&layou
       t=blog&id=9&Itemid=22




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   Method and time of payment:
   Payment to be made with the
       application, in EUROS.
      Proof of payment should
    accompany the application.
   The proof of payment should
 include the following information:
   -Name, pharmaceutical form,
       strength of the product
      -Mutual Recognition and
Decentralised procedure reference
               number
-Name of the applicant/Marketing
        Authorisation Holder




             Mail room:
 Office hours: Monday – Thursday:
8:00 a.m. – 3:00 p.m. Friday: 8:00
          a.m. – 2:00 p.m.
Contact details: Tel: +420 272 185
    806, Fax: +420 271 732 377
   Electronic mail room: e-mail:
            posta@sukl.cz
    Additional information about
 submission of documentation can
be found in SUKL Guideline REG-
   84 (or its revised version; see
 http://www.sukl.eu/medicines/reg-
      84?highlightWords=REG)




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
 Administrative fee in an amount
 stipulated by the SUKL Guideline
    UST-29 shall be paid prior to
  submission of the application by
bank transfer with specific variable
 symbol received from interactive
              form (see
http://www.sukl.eu/modules/payme
     nt/index.php?lang=2). The
 application shall be accompanied
by the interactive form and also by
   bank statement confirming the
              payment.
  Payment of costs incurred by
   expert activities in an amount
 stipulated by the SUKL Guideline
    UST-29 shall be paid prior to
  submission of the application by
bank transfer with specific variable
 symbol received from interactive
              form (see
http://www.sukl.eu/modules/payme
     nt/index.php?lang=2). The
 application shall be accompanied
by the interactive form and also by
   bank statement confirming the
              payment.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   Reference number and invoice
      number must be stated
        Method of payment:
 The state fee has to be paid prior
 the submission of the application.
  Proof of payment of the state fee
     should be enclosed to the
             application




  The proof of payment of the fee
      should be included to the
    application. The proof should
contain the information on the date
 of payment, the (proposed) name
  for the product with the strength
and pharmaceutical form, the name
     of the applicant/marketing
  authorisation holder, method of
         procedure (national
          procedure/mutual
      recognition/decentralised
     procedure) and the type of
              applicant




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
        Method of payment:
   The fee has to be paid to the
Direction des Créances Spéciales
 du Trésor prior the submission of
    the application to Afssaps.
   The Direction des Créances
  Spéciales du Trésor will issue a
receipt for proof of payment which
     must be enclosed to the
            application.




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
       Method of payment:
 Payment on request according to
account of fees (Kostenbescheid).
The “Kostenbescheidnummer” and
the “Kassenzeichen” must always
          be indicated.

     Payments to be made by
    automated credit transfer,
payments from foreign countries by
   automated credit transfer or
   exceptionally by cheque. All
banking charges are to be borne by
           the debtor.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
       Method of Payment:
Payment on request according to a
        notification of fees
     (Kostenbescheid). The
 “Kassenzeichen” must always be
             indicated.

     Payments to be made by
    automated credit transfer,
payments from foreign countries by
   automated credit transfer or
   exceptionally by cheque. All
banking charges are to be borne by
           the debtor.




   Subsequent correspondence
     QualityPart (Module 3):
       Laboratory Division

Subsequent correspondence Non-
Clinical and Clinical Part (Module 4




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   Payment to be made on
application. Proof of payment is
           necessary




      CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
        Method of payment:
   Payment to be made with the
   application in any convertible
currency, and the proof of payment
should accompany the application.
Exceptions when an invoice will be
  sent by the National Institute of
             Pharmacy:
           • Renewal fee
         • Maintenance fee

   The proof of payment should
include information on the product
and the procedure (for details see
    NIP website www.ogyi.hu)




E-mail submission not accepted.




E-mail submission not accepted.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
 For submission of Subsequent
Correspondance relating to Pre-
     Licensing applications:
     Pre-Licensing Section
 For submission of Subsequent
Correspondance relating to Post-
     Licensing applications:
     Post-Licensing Section




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   Method and time of payment:
   Payment to be made with the
       application, in Euros.
 All cheques and drafts should be
      drawn on an Irish bank.

   When making a payment by
EFT/credit transfer, all associated
  charges including beneficiaries
must be settled. The bank advice
 should detail the PA number and
product name, and invoice number
    where applicable. Proof of
payment (EFT/direct debit) should
    accompany the application




       NEW APPLICATIONS:
  Full dossier in electronic format
             (CD/DVD)

            VARIATIONS:
     The application should be
 submitted only through the AIFA
  webportal at the following link:
 http://front-end.agenziafarmaco.it

            RENEWALS:
    The application should be
 submitted both in paper/CD and
through the AIFA webportal at the
            following link:
http://front-end.agenziafarmaco.it




The response document should be
sent to the contactpoint indicated in
 the comment letter form the AIFA
for the specific procedure. It should
   be sent to the e-mail addresses
  indicated only if no contact point
         has been specified.




        CMDh Compiled Contact Points    CMDh/245/2011, Rev5, June 2012
Instructions on method of payment
and applicable fees for all types of
  procedures can be found on the
    website at the following links:
       http:/pol.aifa.gov.it and
http://www.agenziafarmaco.gov.it/e
  n/content/notice-pharmaceutical-
 companies-information-regarding-
    online-system-payment-fees

   Before making any payments
    applicants/MAHs should be
 regestered to the Fees Payment
          Systems (POL) :

         http://pol.aifa.gov.it

Proof of Payment should always be
   included at submission for all
            procedures

 The pharmaceutical company will
 accomplish two payments, one to
 Agenzia Italiana del Farmaco and
    one to the Ministry of Health,
 according to the amount shown in
        the attached price list:
http://pol.aifa.gov.it/docs/tariffarioTa
         bellareING_v114.pdf
for the total of the amount required.

  For the the payment performed
abroad please follow the indications
               below:
http://www.agenziafarmaco.gov.it/e
 n/content/notice-pharmaceutical-
 companies-information-regarding-
    online-system-payment-fees

   All users are reminded that the
rates indicated in the AIFA/ Ministry
of Health table of charges must be
        intended after banking
      commissions and that it is
 furthermore necessary to indicate
  the POL number at the top of the



         CMDh Compiled Contact Points      CMDh/245/2011, Rev5, June 2012
       The applicant is requested
        documentation related to
applications for a human medicinal
        product submit to SAM in
electronic format on electronic data
 carriers - a CD-R, CD-RW or DVD
  or via e-mail with attached secure
     electronic signature.Electronic
documentation regarding marketing
authorisation, renewal and variation
  can be submitted in the following
            way: Option No.1
   The documentation in the eCTD
      format with attached secure
     electronic signature* (created
using a secure electronic signature
   formation method and confirmed
with a certificate) is to be sent to e-
  mail address eCTD@zva.gov.lv .
Documentation files do not exceed
  10MB. Option No.2 In a compact
      disc (CD-R, CD-RW) or DVD
    format, submitted together with
  these documents signed in paper
 format: Cover letter (1 copy). If the
  documents are submitted to SAM
   personally and a confirmation of
   submission is necessary, then 2
      copies should be submitted.
    Application form (application for
marketing authorisation, application
       for renewal, application for
                variation)
    SAM invoice copy and payment
confirmation containing the number
of the SAM issued invoice. In case




         CMDh Compiled Contact Points     CMDh/245/2011, Rev5, June 2012
 Applicant has to make payment in
    advance before handing in the
  documents for medicinal product
       authorization, renewal and
    variations. Method of payment:
1. Submit Payment application (see
 on web-site http://www.zva.gov.lv)
       The file can be submitted
  electronically (rekini@zva.gov.lv).
    2. SAM will forward an invoice.
 Upon making the payment, please
provide invoice number and date
 in the payment purpose section of
       the payment assignment.
     3. Submitting documents for
          receiving services the
    documentation must include: a
    copy of the invoice; a payment
 assignment authorised by a credit
institution or a print of the payment
  made via internet bank of a credit
        institution confirming the
      transaction of the payment.
    The payment assignment must
    contain a clearly legible name,
 surname or title of the payer and it
     must be signed by the payer.
If the payment is made with a bank
   card, the check from SAM cash
   register must be provided. More
 information on fees is available on
 the www.zva.gov.lv on the section
                  Services




 Requirements for e-submissions
   could be find on www.vvkt.lt
              [LT,EN]




        CMDh Compiled Contact Points    CMDh/245/2011, Rev5, June 2012
   Proof of payment should be
provided with the application form
  submitting to State Medicines
   Control Agency of Lithuania.
   Cheques are not accepted.




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   Method and Time of Payment
Proof of payment must accompany
            the dossier.
 Payment must be made through
   Postal Account No. 77 33 70.
Cheques are not accepted. Contact
person: Mr. Carlo Scholl, Inspector.




 Preferably electronic submission
  [eCTD/Non eCTD electronical
       Submission (NeeS)].
 Requested paper copies for each
       application (strength,
    pharmaceutical form etc.):
     MT = CMS/RMS/national
        Application Form: 1
          Cover letter: 1




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
      Payment to be made on
 submission. Proof of payment is
necessary - this should include the
  name of the company effecting
payment (or company on behalf of
  which payment is effected), the
  amount paid, date of payment,
      payment details (type of
 application, reference no, invoice




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
   For all types of applications and
        written responses data:
 Submission of paper copies of the
      regulatory information is by
  legislation no longer accepted in
                    The
              Netherlands.
Information on Electronic Format in
    the Netherlands is available at
             http://www.cbg-
 meb.nl/uk/docs/reghoudr/meb-ers-
                  2.pdf ).
  There are two exemptions to this
   rule: the signed cover letter and
      application form should be
  submitted both electronic and in
  paper until a proper system is in
    place for electronic signatures.
 More information available on the
        website: http://www.cbg-
   meb.nl/uk/reghoudr/index.htm .

 Response documents should be
   sent by e-mail (preferably by
 EudraLink) to: case@cbg-med.nl




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
No payment in advance. A bill is
    sent after receipt of the
      dossier/application




      CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
 National translations of SPC, PIL
 and package should be submitted
   electronically in a word format.
     Please check the following
             information:
http://www.infarmed.pt/pt/noticias_e
ventos/noticias/2005/nt_30_08_200
                 5.pdf




     Please check the following
            information:
http://www.infarmed.pt/portal/page/
portal/INFARMED/ENGLISH/fees.p
                 df
http://www.infarmed.pt/portal/page/
portal/INFARMED/TAXAS/INTROD
UCAO_DE_FICHEIROS/TAB9059/
           GP_AIM.doc




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
 (i) Fees should be paid before
submission of the dossier. Fees
 can be paid by money order or
  bank deposit or directly in the
 cashier’s desk at INFARMED.
  (ii) Confirmation of the fees´s
payment must be included in the
             application




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
  In general Modules 2, 3, 4 and 5
may be submitted in electronic form
if a commitment is made that upon
SUKL´s request a full paper version
 of Modules 2, 3, 4 and/or 5 will be
      submitted within 48 hours.
  In case of submitting registration
dossier for several strengths of the
 medicinal products whit the same
active substance, were a part of the
     documentation for all these
   strengths is identical, applicant
  should submit “identical” Moduls
(except Module 1.2) only once as a
    paper copy and the rest of the
 identical documentation has to be
 submitted electronically (on a CD)




        Method of payment
 Contact with the SIDC to obtain a
variable number for the payment is
            requested.
Payment only to the bank account.
Payment to be made in advance of
            procedure.
     Proof of payment should
    accompany the application




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
         Method of payment:
    Fees have to be paid prior to
  submission of the application, in
                Euros.
 The purpose should be also stated
 (application for MRP/DCP xxx) and
 the claimant (Agency for Medicinal
  Products and Medical Devices of
the Republic of Slovenia = JAZMP).




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
    The instructions to follow with
 regards to the payment of fee,are
   described in the following links
       a)For residents in Spain:
http://www.aemps.gob.es/en/industr
       ia/tasas/pagoTasas.htm
   b) For residents outside Spain:
http://www.aemps.gob.es/industria/t
asas/pagoTasas-noResidentes.htm




Responses that are submitted by e-
 mail should be addressed to the
      general e-mail address
RIC@mpa.se, via normal e-mail or
            Eudralink.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
An invoice will be sent upon receipt
  of the application. No payment
   should be made in advance.




 MHRA has specific areas to
  address your submission to
     depending on type of
 application. Full details of all
Submission Areas are available
     from MHRA website.
 MHRA has specific areas to
  address your submission to
     depending on type of
 application. Full details of all
Submission Areas are available
     from MHRA website.




        CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
     Methods of payment

    Cheques should be made
   payable to "Medicines and
Healthcare products Regulatory
Agency" Cheques should not be
 included within the submission
           package.




       CMDh Compiled Contact Points   CMDh/245/2011, Rev5, June 2012
                     CONTACT POINTS FOR REQUESTS FOR VARIATION GROUPING NUMBERS


(The list is provided to assist pharmaceutical companies in identifying a contact point for
requests for variation grouping numbers in each Member State)

A request for a variation grouping number should be addressed to the contact point of
the RMS prior to submission. Such request is only needed in those cases where the
product counter in the variation procedure number is replaced by a placeholder ‘xxxx’
and consequently the MAH cannot allocate the variation procedure number himself (i.e.
grouped type IA variations including more than one MA)
In all other cases the MAH is responsible for allocating the variation procedure number.

                                                                                         Grouping 1 MA
                                               Allocation of Variation procedure number MAH
      Allocation of MRP variation numbers (for page 3 of the Variation Application Form) MAH
UMBERS




         Grouping >1 MA
         RMS
         MAH

								
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