AMM Template 7.1 - DOC - DOC

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					                                                   NOTICE TO APPLICANTS FOR MARKETING
                                             AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR HUMAN
                                                                   USE*

* This notice to applicants also applies to herbal medicinal products
  subject to registration.                                                                                    REVISION : DECEMBER 2011
.

TRACKING CHANGES
GENERAL INFORMATION                                                                                                    CONTENTS

REQUEST FOR FRANCE ACTING AS THE REFERENCE MEMBER
STATE IN A PROCEDURE
Pre-submission form:                    MRP: FR/EN                         DCP: cmdh_036_2009_rev0_request_form.doc


TERMS OF SUBMISSION
PRESENTATION OF THE SUBMISSION
      ELECTRONIC SUBMISSION
           ELECTRONIC SUBMISSION (EU-NEES/eCTD)
           Electronic submission form                                                      EU-NeeS/eCTD
      PAPER SUBMISSION
           Marketing Authorisation Application
           Variation, Renewal,…
           Additional dossiers

PRACTICAL RECOMMENDATIONS FOR SUBMISSION OR SENDING
           Electronic submission
           Copies A and B
           Copy C

PAYMENT OF FEES                                                   IN FORCE FOR APPLICATIONS                         RECEIVED   BY
           Payment by cheque                                      AFSSAPS UNTIL 31-12-2011.
           Payment by bank transfer

INFORMATION RELATIVE TO THE PROGRESS OF THE PROCESSING
OF DOSSIERS
REQUEST FOR INFORMATION
           Regarding marketing authorisation application
           Regarding variation application

LETTER TEMPLATES AND DOWNLOADABLE FORMS
            Submission cover letters
             o Electronic submission                                                       FR/EN
             o Paper submission                                                            FR/EN
            Electronic submission form                                                    EU-NeeS/eCTD
            Application identification form                                               FR/EN
            Payment transmission form                                                     FR/EN

143/147, bd Anatole France – F-93285 Saint-Denis cedex – tél. + 33 (0) 1.55.87.30.00 - www.afssaps.sante.fr
                                                                           CONTENTS

TRACKING CHANGES
GLOSSARY

GENERAL INFORMATION .................................................................................................................................... 1

REQUEST FOR FRANCE ACTING AS THE REFERENCE MEMBER STATE IN A PROCEDURE ......... 2

TERMS OF SUBMISSION ....................................................................................................................................... 3

1 – PRESENTATION OF THE SUBMISSION....................................................................................................... 3
1.1. ELECTRONIC SUBMISSION ................................................................................................................................ 4

1.1.1. Content and format of the electronic CTD: harmonised European recommendations ............................ 4

1.1.2. Conditions specific to the computer admissibility of an electronic submission to AFSSAPS................ 5

1.1.3. Documents constituting an electronic submission to AFSSAPS ............................................................... 6

1.1.4. Additional dossiers (response to questions, additional request, etc.) ....................................................... 7

1.1.5. Translation proposal ........................................................................................................................................ 8

1.2. PAPER SUBMISSION........................................................................................................................................... 8

1.2.1. Initial application for Marketing Authorisation .............................................................................................. 8

1.2.2. Variation, renewal, etc. ..................................................................................................................................... 9

1.2.2.1. DMIs (national variations) ............................................................................................................................. 9

1.2.2.2. Applications for MA transfer, change of company name and holder/"exploitant"/manufacturer ......... 9

1.2.3. Additional dossiers (response to questions, additional request, etc.) ....................................................... 9

1.2.4. Translation proposal ........................................................................................................................................ 9

1.2.5. Additional CD .................................................................................................................................................. 10

1.3. POSSIBLE SWITCH OF TYPE OF SUBMISSION IN POST-AMM.................................................................... 10


2 – PRACTICAL RECOMMENDATIONS FOR SUBMISSION OR SENDING ............................................. 10
2.1.     Address for sending an electronic submission .......................................................................................... 10

2.2.     Address for sending a paper submission.................................................................................................... 11

2.2.1. Copies A and B (every type of dossier) ....................................................................................................... 11

2.2.2. Copy C (marketing authorisation application or variation application on pharmaceutical quality) ...... 11


3 – PAYMENT OF FEES : IN FORCE FOR APPLICATIONS RECEIVED BY AFSSAPS UNTIL 31-
12-2011 ....................................................................................................................................................................... 11
3.1. Payment by cheque (made out in euros) ........................................................................................................ 12

3.2. Payment by bank transfer (in euros) .................................................................Error! Bookmark not defined.12


INFORMATION RELATIVE TO THE PROGRESS OF THE PROCESSING OF DOSSIERS .................... 13



Notice to Applicants – December 2011
                                               TRACKING CHANGES


 Version Nr               Date                                       Description of changes
                                       Added information since version 2003:
                                         Electronic submission
                                         Information relative to the progress of the processing of the dossier
      01         JULY 2008
                                         Variations concerning Holder and/or "Exploitant"
                                         Distribution by project manager and therapeutic class (DARP/GESPARE)
                                         Letter templates
                                       Information which has been modified since version July 2008:
      02         SEPTEMBER 2008
                                         Distribution by project manager and therapeutic class (DARP/GESPARE)
                                       Information which has been modified since version September 2008:
      03         APRIL 2009              Information relative to the progress of the processing of the dossier
                                         Distribution by project manager and therapeutic class (DARP/GESPARE)
                                       Information which has been modified since version April 2009:
                                         GLOSSARY
                                         GENERAL INFORMATION
                                         Request for France acting as the reference member state in a procedure
                                            (modification of the forms)
                                         Terms of submission:
                                            o 1. Presentation of the submission
                                            o 1.1. Electronic submission
      04         SEPTEMBER 2009             o 1.1.1. Content and format of the electronic CTD: harmonised European
                                               recommendations
                                            o 1.1.2. Conditions specific to the computer admissibility of an electronic
                                               submission to AFSSAPS
                                               Sub-sections 3, 4, 5 and 6
                                               Sub-section 8. Computerised Validation (eCTD or NeeS)
                                            o 1.3 Possible switch of type of submission in post-AMM
                                           Number of paper copies of the dossier: tables 1 to 4
                                           Electronic submission form: NeeS and eCTD
                                           Payment transmission form
                                           Payment of fees
                                            o 3.2 Payment by bank transfer (in euros)
      05               MAY 2010
                                            o Form of submission identification (FR/EN)
                                            o Payment transmission form
                                           Sub-section 8. Computerised Validation (eCTD or NeeS)
                                           Annexe 11 cancelled: user guide validator available via hypertext link.
                                           Terms of submission :
      06          NOVEMBER 2010             o 1. Presentation of the submission
                                           2 – PRACTICAL RECOMMENDATIONS FOR SUBMISSION OR SENDING
                                            (opening hours)

                                          Fees
                                           o 3 – Payment of fees
      07         DÉCEMBRE 2011             o Payment transmission form
                                         In force for applications received by Afssaps until 31-12-2011.
                                         Distribution by project manager and therapeutic class (DARP/GESPARE)




Notice to Applicants – December 2011
                                                                             1
                                                            GLOSSARY

Regulatory Activity
Object of the submission for a dossier, particularly a new marketing authorisation application, type IA, IB or II
variation, periodic safety update report (PSUR), renewal, or follow-up measure (as part of drug safety
assessment after the marketing authorisation is granted).


Application (type of)
Characterisation of the object of the submission defined by the regulatory activity, for example new chemical
entity or extension to the range/different strength, or new pharmaceutical form for a new marketing
authorisation application, extension of indication or variation application of section 4.6 of the Summary of
Product Characteristics (SPC) for a type II variation, etc.


DMI (request for modification of information)
National variation application of the information regarding the pharmacological and clinical data of the
marketing authorisation.


Dossier
The dossier contains together all information submitted in support of the application in compliance with the
recommendations of the CTD (Common Technical Document) published by the European Commission.


eCTD (electronic CTD)
Electronic submission in which the information provided in support of the application complies with the structure
and file formats of eCTD (refer to section 1.1.1).


EU-NeeS (European Union Non eCTD electronic Submission)
Electronic submission in which the information provided in support of the application complies with the structure
and file formats of EU-NeeS (refer to section 1.1.1).


Envelope
Specific to the eCTD format, this dossier contains around ten pieces of structured information specific to the
product and the application (full name, applicant, regulatory activity, type of application, procedure number,
etc.).


Linked Modifications
When a main modification entails, by its nature, one or more other modifications, they are deemed to be linked.
Therefore, all these modifications putting together form a single regulatory activity and the modifications are
submitted in one dossier only (refer to the section 1.2.2.1).
The applicant should justify that the modifications are linked.


Sequence
Specific to the eCTD format, a sequence corresponds to a submission whereby the numbering is defined as
follows: 0000 first submission, 0001 second submission, etc. Generally the 0000 sequence corresponds to the
marketing authorisation application and the subsequent sequences to variation applications, PSUR or renewal.
Nevertheless, it is possible to adopt the eCTD format during the product life cycle, for example upon a major
variation.




Notice to Applicants – December 2011
1                                                                                                                 i
  This glossary has been drawn up from the terms used in the European texts relative to electronic submission.
Submission
A submission corresponds to all (simultaneous) application(s) submitted by a company. The submission may
concern several products; the documentation common to all these applications is then submitted within the
framework of a single submission.


Electronic submission
Submission in which the CTD information provided in support of the application is submitted on an electronic
support, following the harmonised European recommendations for file formats and tables of contents (refer to
section 1.1.1).


Validator
The validator is a tool which is freely downloadable since the AFSSAPS website at the following address:
http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-AMM/(offset)/0#paragraph_20749
This tool allows the applicant check the conformity of the electronic submission according to the criteria
specified in the European guidelines: structure, naming conventions, format and PDF file version.


Validation report
The validation report is a document generated from the validator and the electronic submission. The report is
one of the requested documents that must be attached to the electronic submission. However, it does not imply
the acceptance of the electronic submission.


WORM (Write Once Read Many)
Support informatique non ré-inscriptible




Notice to Applicants – December 2011
1
  This glossary has been drawn up from the terms used in the European texts relative to electronic submission.
                                       GENERAL INFORMATION
This notice to applicants for marketing authorisations for medicinal products for human use amends and
replaces the one published in January 2003. It is available on the AFSSAPS website
(http://afssaps.sante.fr/pdf/3/avammfr.pdf) and specifies the practical terms for submission of marketing
authorisation application dossiers in France and those submitted after the marketing authorisation.
Moreover, this notice also includes the form which has to be sent to AFSSAPS by companies wishing to submit
a marketing authorisation application through the mutual recognition and decentralised procedures, with France
acting as the Reference Member State.
With regard to the terms of submission, the standard CTD (Common Technical Document) format for
presentation of the marketing authorisation application dossier is common to all Member States of the
European Economic Area, both for applications assessed within the framework of European procedures
(mutual recognition procedure, decentralised procedure and centralised procedure) and national applications.
The description of the format and the content of the dossier is available on the website of the Enterprise and
Industry DG of the European Commission at the following address:
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm.
The applicant must refer to the texts published by the European Commission within the framework of
“Regulation of medicinal products in the European Community, volumes IIA and IIB – Notice to applicants for
marketing authorisations for medicinal products for human use in the Member States of the European
Community”, (Eudralex, volume 2, Pharmaceutical Legislation: Notice to Applicants).
These documents, published by the European Commission, are available on the website of the Enterprise and
Industry DG of the European Commission at the address mentioned above.
This document does not apply to the centralised procedure nor Referral procedures, for which
information is available at the following addresses:
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/a/chap4rev200604%20.pdf
http://emea.europa.eu
Initially, it is stated that any submission to AFSSAPS relative to the marketing authorisation must comprise the
following documents:
 original of the submission cover letter (paper submission FR/EN ; electronic submission FR/EN) ;
 3 copies of the submission cover letter;
 2 paper copies of the application identification form for the paper or electronic submission (FR/EN) ;
 2 paper copies of the validation report ("best-report") in case of electronic submission;
 corresponding fees, accompanied by the payment transmission form ; in the event of bank transfer,
     notification of transfer, in the event of payment by cheque, the cheque itself;
 copy of the cheque or notification of transfer, included in the dossier as proof of payment;
 the full dossier in a number of copies in accordance with the type of application and the support chosen for
     the submission;
 where applicable, an additional CD containing the proposed appendices I (SPC), II, IIIA (Labelling) and
     IIIB (Package Leaflet) in French for national procedures (see section 1.1.3) ;
 and in the event of electronic submission, the electronic submission form (EU-NeeS/eCTD).
Furthermore, these documents must be provided simultaneously and INDIVISIBLY.

All the documents should be sent at this following address only:
                       AFSSAPS/DEMEB/DORIS/ Unité Recevabilité AMM (voir rubrique 2.)

         Any incomplete submission (absence of at least one of the expected documents) shall give
        rise to a request for modification. A company that does not produce the requested elements
        within the time frame given by AFSSAPS shall be deemed to have withdrawn its application.
Detailed information relative to:
 the presentation of the submissions;
 the practical recommendations of submission or sending;
 the payment of fees;
are specified respectively in sections 1, 2 and 3.




Notice to Applicants – December 2011                                                                          1
Concerning homeopathic medicinal products subject to registration or marketing authorisation, this notice
completes the explanatory notice describing the content and layout of the dossier, and the practical terms for
submission of the dossiers, available on the AFSSAPS website: http://afssaps.sante.fr/htm/3/indavmed.htm.
Furthermore, this notice specifies the terms of how companies can obtain information relative to tracking the
progress of the processing of marketing authorisation or variation application dossier.


          REQUEST FOR FRANCE ACTING AS THE REFERENCE MEMBER STATE
                               IN A PROCEDURE

When a company requests a Marketing Authorisation Application with France acting as the reference member
state, it is asked to send its application to the Director of the Direction de l’évaluation des médicaments et des
produits Biologiques (DEMEB). This request is accompanied by one of the following forms:
   Mutual recognition procedure: FR/EN

   Decentralised procedure: the form is available at the following address:
    http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/MA_Application/CMDh_036_
    2009_Rev0_Request_Form.doc

The option for AFSSAPS to start a European procedure with France as reference Member State is assessed
with regard to the provisional schedules of activity linked to all marketing authorisation procedures.




Notice to Applicants – December 2011                                                                            2
                                                 TERMS OF SUBMISSION


1 – PRESENTATION OF THE SUBMISSION

Two methods of submission regarding a marketing authorisation or a post-marketing authorisation application
are accepted at AFSSAPS:
   “Paper” submission, accompanied by the submission of the Common Technical Document (CTD)*
    modules concerned on paper support, remains available for all types of application. One or more electronic
    supports (CD or DVD) containing all or part of the dossier must also be provided in addition to the paper.
    However, the reference dossier is the dossier on paper support (see section 1.2).
   “Electronic” submission, accompanied by the submission of the CTD* modules concerned on electronic
    support only, is accepted:
    o    In the case of an EU-NeeS, exclusively for the following regulatory activities:
          new applications,
          type II variations,
          periodic safety update report (PSUR) submitted only within the framework of the drug safety
              assessment after the marketing authorisation is granted.
          any MRP application submitted by at least one European Union Member State not involved in the
              first use and concerning a Marketing Authorisation granted within the European Union whether
              France is RMS or CMS (a start of a Mutual Recognition Procedure with France as Reference
              Member State and "Repeat use"),
          renewals.
    o    In the case of an eCTD:
         The first submission should be one of the regulatory activities mentioned above (in case of an EU-
         NeeS). Whatever the regulatory activity concerned, the eCTD format should be used for the submission.

    o    When the size of the dossier exceeds one double-layer DVD, the eCTD format only is accepted and
         it must not be zipped (see section 1.1.2.).
The practical details of electronic submission are detailed in section 1.1 below.

                         For electronic submission, it is prohibited to submit some or all of
                                           the modules on paper support.


For any request for information relative to the terms of electronic submission, please send an email to:
                                   info.esoumission@afssaps.sante.fr




* Including « mock-up » proposals according to article 5121-25 of “Code de la Santé Publique”




Notice to Applicants – December 2011                                                                        3
1.1. ELECTRONIC SUBMISSION
The electronic submission is accepted by AFSSAPS for the dossiers submitted in national, mutual recognition or
decentralised procedures and the regulatory activities mentioned above.

In the case of an EU-NeeS, no regulatory activity other than these mentioned above may be subject to EU-
NeeS submission.

In the case of an eCTD, once one of the regulatory activities mentioned above has been subject to electronic
submission in eCTD, AFSSAPS will accept any later submission in eCTD, regardless of regulatory activity
concerned.


1.1.1. Content and format of the electronic CTD: harmonised European recommendations
Two types of organisation of the CTD on electronic support exist in the European Union and are accepted by
AFSSAPS: eCTD and EU-NeeS. Both have common specifications throughout the European Union and
AFSSAPS does not accept any other electronic file formats.
   eCTD organisation
    The format and content of the eCTD have been defined by the ICH (International Conference on
    Harmonisation) and are therefore common and harmonised in the United States, Japan and the European
    Union, with the exception of module 1 for which the content relates to regional specificities (Application
    Form and product information proposals).
    Data in the CTD modules concerned must be provided in PDF 1.4 for the text parts. In the absence of
    absolute impossibility, PDF must be generated from an electronic file (not scanned) and in "OPEN" format
    that is to say not protected by a password and not encrypted.
    This is strongly recommended for:
              o the part relative to the Environmental Risk Assessment of module 1,
              o module 2,
              o the body of the core study reports of modules 4 and 5.

    A limited number of specific formats is accepted for pictures, SAS output: PDF, JPEG, PNG, SVG, GIF,
    SAS*, RTF, XML
    The eCTD is characterised by the additional presence of two files in XML format:
           o a general and navigable index of the file,
           o an envelope with structured data which define the product and the submission.
    For further information, refer to the following websites:

    EU-NeeS guidance
          http://esubmission.emea.europa.eu/doc/NeeS eGuidance Document version 2.0.pdf
    eCTD guidance
          http://www.emea.europa.eu
          http://estri.ich.org/eCTD/index.htm
          http://esubmission.emea.europa.eu/doc/eCTD Guidance Document 1.0 FINAL FOR
           PUBLICATION.pdf

   EU-NeeS organisation
    This file structure is common to all European Union. The harmonised specifications are available on the
    website of the European Medicines Agency (EMEA) at the following address:
          http://esubmission.emea.europa.eu/doc/NeeS eGuidance Document version 2.0.pdf
    Similarly, the data of the modules concerned of the CTD must be provided in PDF 1.4 for the text parts. In
    the absence of absolute impossibility, PDF must be generated from an electronic file (not scanned) and in
    "OPEN" format that is to say not protected by a password and not encrypted.
    This is strongly recommended for:
                o part relative to the Environmental Risk Assessment of module 1,
                o module 2,
                o body of the core study reports of modules 4 and 5.




Notice to Applicants – December 2011                                                                        4
    The EU-NeeS structure differs from that of the eCTD only in the absence of the general index and
    envelope files. Navigation within the dossier must consequently be based on the presence of electronic
    tables of contents navigable via bookmarks and hypertext links.

    It is mandatory to provide tables of contents in PDF format according to the following three fixed levels:
     1. A general table of contents of the file
        Obligatorily called ctd-toc.pdf, this table of contents is a general one.
     2. Individual tables of contents for each module
        Each of these tables of contents must make it possible to link the entries to the files concerned via
        hyperlinks.
     3. Individual table of contents of the document
        Each document must contain bookmarks linking each entry with the files concerned via hyperlinks.

    With regard to the file names, the conventions recommended by ICH must imperatively be followed for
    EU-NeeS: see ICH, eCTD specification v3.1, "naming conventions" http://estri.ich.org/eCTD/index.htm.



1.1.2. Conditions specific to the computer admissibility of an electronic submission to
       AFSSAPS

In addition to the ICH, eCTD and EU-NeeS recommendations, AFSSAPS has defined specific conditions as
follows:

1. Regulatory activity:
    o    In the case of EU-NeeS, the regulatory activity must exclusively be one of the following:
          marketing authorisation applications,
          type II variations (clinical data) (sections 4 and 5 of the SPC),
          PSURs submitted only within the framework of the clinical safety assessment after the marketing
              authorisation is granted.
    o    In the case of eCTD:
         Where one of the three regulatory activities mentioned above has been subject to an initial electronic
         submission in eCTD, AFSSAPS will accept any later submission in eCTD, regardless of regulatory
         activity concerned. However, it is currently recommended that these later eCTD submissions concern
         marketing authorisation applications (extensions to the range), type II variations (clinical data) and
         PSURs.

2. The SUBMISSION must be made in ONE COPY ONLY.

3. Optimisation of the number of WORM disks is mandatory:

The « multi supports » submission are accepted in case of eCTD only.
    o    If total file size is < 650 Mb: one single CD-R.
    o    If total file size is < 650 Mb and < 4.7 Go: one single DVD-R or DVD+R.
    o    Beyond an unzipped double-layer DVD, submission in eCTD only will be accepted.
    o    If total file size is  4.7 Go: one or more double-layer DVD-R or double-layer DVD+R (as necessary and
         identified by a Nr X/Y, e.g.1/2 or 2/2) submission in eCTD only will be accepted.
In a general way, the rule is as follows:


     All data of the dossier must be recorded onto one single WORM disk that cannot be re-written
     and clearly identified (EU-NeeS/eCTD) and in one copy only. The burning session must be
     closed. For further details, refer to the electronic submission form (EU-NeeS/eCTD).
     Use one or more double-layer DVDs, only when the dossier exceeds the capacity of one DVD.




Notice to Applicants – December 2011                                                                             5
4. A submission must refer to one procedure number only and must contain one regulatory activity only.
5. If several identical applications concern different products and correspond to different strengths and/or
   different pharmaceutical forms of the same product and if the documentation is shared, it is possible:
    o either to submit them within the structure of one single common dossier:
          M1 with as necessary "application form" files and "Information product" files as of strengths and
             pharmaceutical forms,
          common M2 to M5;
    o or to submit separately one full dossier for each strength or pharmaceutical form (one support per
         strength/pharmaceutical form).

              Whatever the chosen solution will be, this solution should be imperatively followed for the
              upcoming submission. The structure "Parent/Child" is not accepted.

6. Under any circumstances, the burned files must not be zipped or compressed or .exe files, and the burning
   session must imperatively be closed.
7. The content of the submission must be complete as described in section 1.1.3. below.


8. Computerised validation (eCTD or NeeS)
    All the electronic submissions are submitted to a computerised validation performed by AFSSAPS
    according to the criteria specified in the European guidelines (PDF file version, structure, naming
    conventions, MD5 for eCTD). If any error is reported, the electronic submission will be rejected due to the
    non electronic compliance.
    In order to produce an electronic submission in compliance, a validator is at the disposal
    of the applicants:
     o the validator is freely downloadable since the AFSSAPS website at the following address:
         http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-AMM/(offset)/0#paragraph_20749;
     o the validator is the result of the European harmonisation work on the validation criteria and has been
         developed by Extedo in partnership with European national agencies and EMA using the software
         Review EURS is yours
     o this validator must be used by the applicant to test the compliance of the electronic submission;
     o the applicant will submit an electronic submission to the AFSSAPS only if the validation report
         ("validation report") has not identify error(s); see more information on the tested criteria and conditions
         of acceptance in the guidance how using the validator available on the website of the AFSSAPS;
     o the applicant is required to imperatively enclose the validation report with the submission; the validation
         report is one of the mandatory documents;
     o the attendance of the validation report doesn't imply the whole and definitive acceptance of the
         submission.


                        Any submission not respecting these 8 prerequisites shall give rise to a
                       request for modification. Any company not complying with the time frame
                        given by AFSSAPS shall be deemed to have withdrawn its application.




1.1.3. Documents constituting an electronic submission to AFSSAPS

     1. Concerned CTD modules on electronic support only (paperless)
         Refer to the references to reproduce on the disk in appendix EU-NeeS/eCTD).

     2. AFSSAPS form for electronic submission
         A single paper form per submission (regulatory activity), duly completed, must be attached
         (see appendix EU-NeeS/eCTD).




Notice to Applicants – December 2011                                                                              6
     3. Original of the submission cover letter
         A single letter per regulatory activity specifying:
              whether it relates to an eCTD or an EU-NeeS;
              the sequence number, if the submission is in eCTD format;
              for an eCTD, the full summary of the regulatory activities and sequence numbers previously
               submitted to AFSSAPS for one or more products concerned by the submission;
              the number of supports and corresponding serial numbers: the serial number of the CD, DVD or
               double-layer DVD, written on the centre of the disk, must be visible and legible;
              confirmation that the application is submitted in a single copy;
              confirmation that the burning session has been closed;
              confirmation that the support has been subject to a negative virus scan before submission.
         A template letter is available in appendix FR/EN.

     4. Three copies of the submission cover letter.

     5. For national procedure applications, an additional CD clearly separated and identified
         For national procedure applications, supported by a proposal of appendices (I (SPC), II, IIIA (Labelling)
         and IIIB (Package Leaflet)), it is requested to systematically add one file per product in Word format,
         style sheet, Template 7 (template available on the website http://afssaps.sante.fr/htm/3/indavmed.htm).
                    N.B. for each product, the proposed appendices (I (SPC), II, IIIA
                    (Labelling) and IIIB (Package Leaflet)) must constitute only one
                    single file in Word format, style sheet, Template 7 (template
                    available on the website:
                                http://afssaps.sante.fr/htm/3/indavmed.htm).
                    Thus, the CD must contain as many files as products concerned by
                    the submission.


     Refer to the references to reproduce on the additional CD in appendix 6.

     6. Fees accompanied by the payment transmission form (cf. appendix 8-FR or 8-EN)
         The terms of payment are specified in chapter 3.

     7. Application identification form (cf. appendix 7-FR or 7-EN)


     8. Two paper copies of the validation report ("validation report")
        http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-AMM/(offset)/0#paragraph_20749

All of these documents must be sent, under the following terms, to:

                            AFSSAPS / DEMEB / DORIS/ Unité RECEVABILITE AMM
                                  Electronic submission (eCTD/EU-NeeS)
                                 143-147 BOULEVARD ANATOLE FRANCE
                                       F-93285 SAINT-DENIS CEDEX

      Under no circumstances may the electronic submission give rise to a request for obtaining
             additional disk or paper copies when the submission has been considered
                     as admissible on a computer and an administrative basis.


1.1.4. Additional dossiers (response to questions, additional request, etc.)
Any additional file has to be submitted on the same supports and formats as those of the initial submission:
   eCTD submission  new sequence according to the recommendations specified in section 1.1 (electronic
    submission form (EU-NeeS/eCTD)) ;
   EU-NeeS submission  new EU-NeeS according to the recommendations specified in section 1.1
    (electronic submission form (EU-NeeS/eCTD)).




Notice to Applicants – December 2011                                                                            7
1.1.5. Translation proposal
Within the framework of mutual recognition or decentralised procedures, translation proposals must be
transmitted within 5 days of the end of the European procedure:
   by email, to the email address of the project manager identified according to the therapeutic class
    concerned (refer to the flow chart in appendix);
   by post, sent in 1 copy to the DEMEB/Department of Regulatory Affairs and Management of Marketing
    Authorisation Procedures (DARP), Registration Procedures and European Affairs Unit (GESPARE unit).
The subject of the email must specify the name of the product, the procedure number and the dossier code
(NL type).
Electronic files are to be provided in Word format, style sheet, Template 7 (template available on the website:
http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-AMM/(offset)/0#paragraph_20749).



1.2. PAPER SUBMISSION
1.2.1. Initial application for Marketing Authorisation
   The applicant is bound to provide several copies (both sides recorded) of the marketing authorisation
    dossier intended for the assessment and archiving. The number and constitution of the paper copies to be
    provided are specified in tables 1, 2 and 4 in appendix.
   Ideally, all documents must be bound, either heat-bound or with “spiral binding”.
   These copies are to be labelled "A", "B" or "C":
     o Copy "A" is the copy of the dossier for archiving and it contains all modules. It must be presented in
       boxes labelled “Copy A”. It is intended for the Direction de l'évaluation des médicaments et des produits
       biologiques (DEMEB).
     o The two "B" copies of the dossier are used for the assessment and are presented in boxes labelled
       “Copy B1” and “Copy B2”. They are intended for the Direction de l'évaluation des médicaments et des
       produits biologiques (DEMEB). Additional copies of some modules may be requested only in the case
       of paper submission (see tables 1, and 2 in appendix).
     o Copy "C" is the file intended for the Direction des Laboratoires et des Contrôles (DLC). It contains
       modules 1, 2 and 3 (CTD format) of the dossier.

   Upon simultaneous applications, it is possible to simplify the presentation of the dossiers submitted on
    paper for national, mutual recognition and decentralised procedures:
     o for simultaneous applications which concern several identical products and for which the regulatory
       basis is the same:
        only one full dossier has to be submitted,
        in the application letter and in modules 1 and 2 of the other dossiers, reference must be made to
            the submitted documentation of the first dossier. The names of all products concerned must be
            mentioned on the cover page of each of the common volumes (modules 3, 4 and 5).
     o for simultaneous applications which concern several products containing the same active substance(s),
       presented under different strengths and/or different pharmaceutical forms:
        only one full dossier has to be submitted,
        in the application letter and in modules 1 and 2 of the other files, reference must be made to the
            submitted documentation of the first dossier. All strengths and/or pharmaceutical forms must be
            mentioned on the cover page of each of the common volumes (modules 4 and 5).
    The number and constitution of the paper copies to be provided are specified in table 2 appended.




Notice to Applicants – December 2011                                                                          8
1.2.2. Variation, renewal, etc.
For each variation or renewal application, or any additional document submitted during the procedure, the
applicant is bound to provide the number of paper copies mentioned in table 3 appended.


1.2.2.1. DMIs (national variations)

For requests for modification of information (DMIs), in paper submission and regarding clinical safety data in
national procedures, the files must be presented as follows:
   in the case of a non-linked modifications, it is necessary to submit as many dossiers as modifications,
    along with the corresponding forms and fees;
   in the case of linked modifications, it is necessary to submit a single dossier per product or for a range of
    products based on the same active substance, all modifications requested setting together; the laboratory
    must specify, in the cover letter, the scientific argument justifying the link between the modifications.
    Corresponding fees and, where appropriate, the form for each product have to be attached to the dossier.
    All strengths and/or pharmaceutical forms must be mentioned on each cover page.


1.2.2.2. Applications    for    MA    transfer,             change        of     company         name         and
         holder/"exploitant"/manufacturer

In the case of a variation application concerning requests for MA transfer, change of company name and
holder/"exploitant"/manufacturer, the presentation of the applications submitted on paper in national procedures
may be simplified (refer to table 5 appended).



1.2.3. Additional dossiers (response to questions, additional request, etc.)
Any additional file must be submitted under the same support and format as those of the initial submission:
   paper support  paper addition (application identification form (FR/EN)) ;

Response files:
 These must be subject to the same methods of submission as for the initial application (see chapter 1 and
   tables 1, 2, 3 and 4 in appendix).
   In case of email exchanges giving rise to the sending of a file, a paper copy of the said file must be
    systematically submitted for archiving, accompanied by a letter specifying “single copy for archiving”.



1.2.4. Translation proposal
Within the framework of mutual recognition or decentralised procedures, translation proposals must be
transmitted within 5 days of the end of the European procedure:
   by email, to the email address of the project manager identified according to the therapeutic class
    concerned (refer to the flow chart in appendix);
   by post, sent in 1 copy to the DEMEB/Department of Regulatory Affairs and Management of Marketing
    Authorisation Procedures (DARP), Registration Procedures and European Affairs Unit (GESPARE unit).
The subject of the email must specify the name of the product, the procedure number and the dossier code
(NL type).
Electronic files are to be provided in Word format, style sheet, Template 7 (template available on the website:
http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-AMM/(offset)/0#paragraph_20749).




Notice to Applicants – December 2011                                                                            9
1.2.5. Additional CD
For national procedure applications, it is recommended to systematically add one file per product containing the
proposed appendices (I (SPC), II, IIIA (Labelling) and IIIB (Package Leaflet)) in Word format, style sheet,
Template 7 (template available on the website: http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-
AMM/(offset)/0#paragraph_20749.


                    N.B. for each product, the proposed appendices (I (SPC), II, IIIA
                    (Labelling) and IIIB (Package Leaflet)) must constitute only one file
                    in Word format, style sheet, Template 7 (template available on the
                    website: http://www.afssaps.fr/Previsu/Constitution-de-dossier-d-
                    AMM/(offset)/0#paragraph_20749 .
                    Thus, the CD must contain as many files as products concerned by
                    the submission.


1.3. POSSIBLE SWITCH OF TYPE OF SUBMISSION IN POST-AMM
Switch from one type of submission to another is possible. However, the switch should meet all the
requirements described in appendix (EU-NeeS or eCTD).




2 – PRACTICAL RECOMMENDATIONS FOR SUBMISSION OR SENDING
The procedure type, procedure number, application type, dossier code (NL type), CIS code, ATC code, and the
contact details of the person responsible for the dossier within the company, are to be specified in the subject of
the submission cover letter (paper submission FR/EN ; electronic submission FR/EN).
In all cases, whether it relates to a marketing authorisation application or a post-marketing authorisation dossier
(variation, renewal, etc.) including the additional files, the application identification form (FR/EN) must be duly
completed and attached to every cover letter sent in order to facilitate the administrative processing of the case
within AFSSAPS. It is recommended that this form is affixed to the boxes or envelopes.
In the case of a submission, contact:
   the marketing authorisation admissibility unit, situated on the ground floor at the rear of the main building,
   From November 2, 2010, opening hours are 08:00 a.m. to 05:00 p.m. Monday to Friday (with no
    interruption).
Before any large delivery (over twenty parcels), notify the Marketing Authorisation Admissibility Unit at
least 10 days before the planned delivery date, by fax on 33 (0)1 55 87 33 11.
All volumes of a dossier must be submitted on the same day (no splitting of the application).


2.1.     Address for sending an electronic submission

Applications submitted electronically (eCTD, EU-NeeS) are to be sent, in accordance with the following
terms to:

                            AFSSAPS / DEMEB / DORIS/ Unité RECEVABILITE AMM
                                 Soumission électronique (eCTD/EU-NeeS)
                                 143-147 BOULEVARD ANATOLE FRANCE
                                       F-93285 SAINT-DENIS CEDEX




Notice to Applicants – December 2011                                                                                 10
2.2.     Address for sending a paper submission

2.2.1. Copies A and B (every type of dossier)
Dossiers of marketing authorisation applications (copies A and B) and dossiers submitted after the marketing
authorisation is granted (variation, renewal, etc.) are to be sent simultaneously and indivisibly to:
                             AFSSAPS / DEMEB / DORIS / Unité Recevabilité AMM
                                     143-147 boulevard Anatole France
                                       F-93285 SAINT-DENIS Cedex


2.2.2. Copy C (marketing authorisation application or variation application on pharmaceutical
       quality)
Copy C of the dossiers must be sent to one of the following addresses:

   Blood-derived drugs, allergens, medicines          AFSSAPS
   originating from biotechnologies and proteins,     Direction des Laboratoires et de Contrôles
   homeopathic medicines, herbal medicines            Unité Logistique
                                                      143 – 147, Boulevard Anatole France
                                                      F-93285 SAINT-DENIS Cedex
   Medicinal products of chemical origin              AFSSAPS
                                                      Direction des Laboratoires et des Contrôles
                                                      Unité Logistique
                                                      635, rue de la Garenne
                                                      F-34740 VENDARGUES
   Vaccines or immunologic medicinal products         AFSSAPS
                                                      Direction des Laboratoires et des Contrôles
                                                      Site de Lyon
                                                      Unité Logistique Scientifique
                                                      321, avenue Jean-Jaurès
                                                      F-69700 LYON




Notice to Applicants – December 2011                                                                      11
3 – PAYMENT OF FEES                                   IN FORCE FOR APPLICATIONS               RECEIVED     BY
                                                      AFSSAPS UNTIL 31-12-2011.

Every application relative to a marketing authorisation (MA application, renewal or variation) must be
accompanied by payment of fees in compliance with the legislation in force (see payment transmission form).
It is stated that fees must be paid for each marketing authorisation or post-marketing authorisation application.
Consequently, there must be fees attached to the application for each marketing authorisation concerned by
the application.
The terms of payment are identical regardless of the support for submission.


3.1. Payment by cheque (made out in euros)
   Draw up the cheque(s) (made out in euros) payable to the Accounts Officer of AFSSAPS and obligatorily
    attach it to the original of the cover letter (see General Information) accompanied by the payment
    transmission form.
   For homeopathic medicinal products subject to registration or marketing authorisation, a payment
    transmission form specific to these medicinal products is available on the AFSSAPS website:
    http://afssaps.sante.fr/htm/3/indavmed.htm.
   The amount of the cheque(s) and the payment transmission form must correspond to the legal basis of the
    application (Module 1 of the application), the number of strengths, pharmaceutical forms, etc.


3.2. Payment by bank transfer (in euros)
   Draw up the bank transfer(s) (made out in euros) payable to the Accounts Officer of AFSSAPS and
    obligatorily attach it to the original of the cover letter (see General Information) accompanied by the
    payment transmission form.
   The notification of transfer (in euros) must obligatorily specify:
Concerning new application: name of the applicant of the Marketing Authorisation, medicinal product name, type
of submission (new application) and procedure number in case of a European procedure dossier.
Concerning modifications and renewal: name of the holder of the Marketing Authorisation, medicinal product
name, type of submission, NL code and procedure number in case of a European procedure dossier.


Bank references of the AFSSAPS account (RIB / IBAN):
                             TRESORERIE GENERALE DE LA SEINE SAINT-DENIS
                             13 ESPLANADE JEAN MOULIN
                             93009 BOBIGNY
                             Bank code: 10071
                             Sort code: 93000
                             Account n°: 00001000737 Rib key 51
                             IBAN code: FR76 1007 1930 0000 0010 0073 751
                             BIC/SWIFT code: BDFEFRPPXXX

It is stated that bank charges related to the transfer are payable by the ordering company.
In both cases, the Accounts Agency will return a copy of the payment transmission form, as proof of registration
of the payment, to companies that enclose a stamped addressed envelope for this purpose.
Under no circumstances may the fees be transferred from one application to another.
Any request for reimbursement relative to a marketing authorisation application must be duly justified, either
through an obvious error by the applicant, or if the dossier is incomplete with regard to the legislation in force.
A request for reimbursement must be made within a period of one month of submission in the event of obvious
error, and within a period of one month of a request by AFSSAPS for missing information when the dossier is
incomplete.
The request must be sent to the General Director of AFSSAPS.
Fees may only be reimbursed if assessment of the dossier has not begun.




Notice to Applicants – December 2011                                                                             12
    INFORMATION RELATIVE TO THE PROGRESS OF THE PROCESSING OF DOSSIERS

Companies may get information regarding the state of progress of the dossiers submitted:

    for marketing authorisation applications in the following context:
                                 th
              o   from the 100 day after assessment in national procedures;
              o   after the end of the European assessment phase in mutual recognition and decentralised
                  procedures.

     To this end, telephone support (working days only and preferably in French language) is offered from
     2 p.m. to 4 p.m. on 33 (0)1 55 87 37 37:

               Thursdays for applications relative to generic medicinal products in national procedure ;

               Mondays and Wednesdays for any other marketing authorisation application.


    for clinical variation application:
     Information on the state of progress of clinical variation applications, according to the therapeutic class,
     may be obtained from the project managers of the Department of Regulatory Affairs and Management of
     Marketing Authorisation Procedures, Registration Procedures and European Affairs Unit (GESPARE unit).
     For the distribution of the therapeutic classes allocated to each project manager, refer to the flow chart in
     appendix.

    for pharmaceutical variation application:
     Information on the state of progress of pharmaceutical variation applications may be obtained:
      o for chemical substance, homeopathic and herbal medicinal products: from the "Département de
        l'Evaluation de la Qualité Pharmaceutique" - DEMEB,
      o for biological substance: from the "Département de l’Evaluation des Produits Biologiques" - DEMEB.




Notice to Applicants – December 2011                                                                            13
                                                      TABLEAU 1

                                          Number of paper copies of the dossier


     To facilitate the treatment of the dossiers, in addition to the paper copies, it is recommended
     to submit one CD containing the Word files corresponding to the different modules. The
     Word files should be ordered in the same way as the structure of the dossier.



                                 MARKETING AUTHORISATION APPLICATION
                            National, mutual recognition and decentralised procedures

                     Copy               Copies        Copy                                      Total number of
                                                                                                    copies
                        A                  B            C           Additional B Copy(s)
                    Archiving          Assessment     Control                                   A+B        C*

 Module 1               1                  2            1         17                             20       1
 Module 2               1                  2            1         17                             20       1
                                                                  biological medicinal
                                                                   products: 2                    5        1
                                                                  herbal medicinal
 Module 3               1                  2            1          products **: 2                 5        1
                                                                  homeopathic medicinal
                                                                   products:
                                                                   1 per type of strain

                                                                 The applicant must be able
                        1                  2            0        to provide additional copies     3        0
 Module 4
                                                                 on request.

                                                                 The applicant must be able
 Module 5               1                  2            0        to provide additional copies     3        0
                                                                 on request.

*Paper copy "C" is to be sent to the Direction des Laboratoires et des Contrôles (DLC). Modules 1, 2 and 3 of
the application must be included.
** These requirements also apply to herbal medicinal products subject to registration.

 For a start of a Mutual Recognition Procedure, with France as Reference Member State (first wave or repeat-
                   use procedure), a full and updated dossier must be submitted (see table 1).




Notice to Applicants – December 2011                                                                            14
                                                              TABLEAU 2

                                                Number of paper copies of the dossier


        To facilitate the treatment of the dossiers, in addition to the paper copies, it is recommended
        to submit one CD containing the Word files corresponding to the different modules. The
        Word files should be ordered in the same way as the structure of the dossier.



         MARKETING AUTHORISATION APPLICATION: case of simultaneous applications for
          identical products or with a same active substance and same regulatory basis1 2
                                 National, mutual recognition and decentralised procedures
                                                                                                                 Total number of
                                         A             B                 C              Additional B                 copies
                                    Archiving      Assessment         Control             Copy(s)
                                                                                                                 A+B             C*

    Initial application                                                               Full dossier (see table 1)


    Each simultaneous application (identical
    strength and pharmaceutical form) 2 3
    Module 1                             1             2                  1           17                          20             1
    Module 2                             1             2                  1           17                          20             1
    Module 3                             1             0                  0           0                            1             0


    Each simultaneous application (different
    strength and pharmaceutical form) 3
    Module 1                             1             2                  1           17                          20             1
    Module 2                             1             2                  1           17                          20             1
    Module 3                             1             2                  1           0                            3             1




1
    Called “duplicate/multiple applications”
2
    Make reference in the application letter and in modules 1 and 2 to the documentation submitted for the first application. All strengths
    and/or pharmaceutical forms must be mentioned on the cover page of each of the common volumes (modules 3, 4, and 5) (see section
    2).




Notice to Applicants – December 2011                                                                                                    15
                                                     TABLEAU 3


                                       Number of paper copies of the dossier



                     DEMANDE DE MODIFICATIONS d’AMM, PSUR, Renouvellement
                             Procédure nationale, de mutual recognition, décentralisée

                                          Letter        Copy             Copies          Copy
                                        1 original                                                 Total number
 Type of application                                       A                 B             C
                                       + number of                                                   of copies
                                          copies       Archiving        Assessment       Control

 Variation application                    1+3              1                 2             1*        3 (+ 1*)
 PSUR                                     1+2              1                 1             0             2
 Renewal in European
                                          1+4              1                 3             0             4
 procedure
                                                           1                 1
 Renewal in national                                  each module       each module
 procedure: simplified                    1+3        and readability   and readability     0             2
                                                      user testing      user testing
 dossier**                                              must be           must be
                                                       separated         separated

                                                           1                 1
 Renewal in national                                  each module       each module
 procedure: consolidated                  1+5        and readability   and readability     0             2
                                                      user testing      user testing
 dossier **                                             must be           must be
                                                       separated         separated

* For all applications affecting the pharmaceutical documentation, copy “C” is to be sent to the Direction des
   Laboratoires et des Contrôles (DLC).
** Content of the marketing authorisation renewal application dossier in national procedure, specified by ruling
of May 6, 2008 regarding marketing authorisation renewals.




Notice to Applicants – December 2011                                                                             16
                                                    TABLEAU 4


                                        Number of paper copies of the dossier



                                       ADDITIONAL FILE: National Procedure
                                                    Letter         Copy              Copies
                                                  1 original                                       Total number of
 Type of application                                                 A                  B
                                                 + number of                                           copies
                                                    copies       Archiving          Assessment

 Response to Notification of Negative                1+3             1                  2                   3
 opinion (following a variation application)

 Response to "projet de rejet" or
 "Mesure d'instruction" or any other
 response document
  general case                                      1+4             1                  3                   4
  homeopathy/herbal medicinal
    products                                         1+5             1                  4                   5

                    ADDITIONAL FILE: Mutual recognition and decentralised procedures
                                                     Letter        Copy              Electronic documentation
                                                   1 original                             for assessment
                                                  + number of        A
                                                                                (ONLY if the initial application has been
                                                     copies       Archiving          submitted in paper format)
                                                                                     1 courriel à envoyer             à
 Document of responses to questions                  1* + 1          1                ueurop@afssaps.sante.fr
                                                                                     4 CD


* For any submission of document of responses to questions, it should be specified, on the cover letter, that this
single paper copy « A » has been the subject of a previous email or CD and that this paper copy "A" takes up
the same documentation.




Notice to Applicants – December 2011                                                                                    17
    TABLEAU 5
    Unité modification
                                 Transfer of marketing         Change of name and/or           Change of                 Change of name and/or        Co-distribution
                                 authorisation holder (art.    address of the marketing        “exploitant” (art.        address of the               (art. R.5121-41 and
                                 R 5121-46 of the FPHC)        authorisation holder            R.5121-41 and             “exploitant”(art. R.5121     R.5124-2, 3° of the
                                                                                               R.5124-2, 3° of the       -41 and R.5124-2, 3° of      FPHC)
                                                                                               FPHC)                     the FPHC)
1. Type of additional activity                                 Type IA variation

2. Content of the dossiers        1 cover letter per NL or     1 cover letter per NL or       1 cover letter per       1 cover letter per NL       1 cover letter per NL
                                   for all NLs concerned,        for all NLs concerned,          NL or for all NLs         or for all NLs               or for all NLs
                                   sent by the future            sent by the marketing           concerned, sent by        concerned, sent by the       concerned, sent by the
                                   marketing authorisation       authorisation holder            the marketing             marketing                    marketing
                                   holder, explaining the       Variation form                  authorisation             authorisation holder,        authorisation holder,
                                   current situation and the    A formal document from          holder, explaining        explaining the current       explaining the current
                                   new situation proposed.       a relevant official body        the current situation     situation and the new        situation and the new
                                  Payment transmission          (e.g. Chamber of                and the new               situation proposed           situation proposed
                                   form                          Commerce) in which              situation proposed,      Payment transmission         with the division of
                                  Administrative                the new name or new             with information          form                         operations by each
                                   identification form           address is mentionned           about a French-          Administrative               entity and with
                                  Name and address of          Payment transmission            speaking                  identification form          information about a
                                   the future marketing          form                            representative (if       Current                      French-speaking
                                   authorisation holder,        Administrative                  possible) and his         pharmaceutical site          representative (if
                                   those of the                  identification form             telephone number if       authorisation                possible) and his
                                   “exploitant”and the                                           the proposed              mentioning the new           telephone number if
                                   manufacturer (where                                           “exploitant” is not       company name and/or          the proposed
                                   neither the future                                            based in France.          the new address, or a        “exploitant”is not
                                   marketing authorisation                                      Payment                   formal document from         based in France.
                                   holder nor the                                                transmission form         a relevant official body    Payment transmission
                                   “exploitant” undertakes                                      Administrative            (e.g. Chamber of             form
                                   the manufacture)                                              identification form       Commerce) in which          Administrative
                                  Name of the product,                                         Current                   the new name or new          identification form
                                   and its composition                                           pharmaceutical site       address is mentionned       Current
                                  SPC                                                           authorisation            Letter stating that the      pharmaceutical site
                                  A copy of the marketing                                      Letter stating that       “exploitant”complies         authorisation
                                   authorisation, certified                                      the “exploitant”          with the marketing          Letter stating that the
                                   by the holder;                                                complies with the         authorisation dossier        ”exploitant”(s) comply
                                  The agreement of this                                         marketing                Copy of the marketing        with the marketing
                                   holder to the transfer of                                     authorisation             authorisation                authorisation dossier
                                   the marketing                                                 dossier                  Draft amended               Copy of the marketing
                                   authorisation;                                                                          marketing                    authorisation
                                                                                                                           authorisation

                                                                     Notice to Applicants – December 2011                                                                18
Transfer of marketing          Change of name and/or          Change of             Change of name and/or      Co-distribution
authorisation holder (art.     address of the marketing       “exploitant” (art.    address of the             (art. R.5121-41 and
R 5121-46 of the FPHC)         authorisation holder           R.5121-41 and         “exploitant”(art. R.5121   R.5124-2, 3° of the
                                                              R.5124-2, 3° of the   -41 and R.5124-2, 3° of    FPHC)
                                                              FPHC)                 the FPHC)
 The designation of the                                       Copy of the                                     Draft amended
   manufacturing, control                                       marketing                                        marketing
   and packaging sites;                                         authorisation                                    authorisation
 The applicant’s                                              Draft amended
   agreement to submit to                                       marketing
   all conditions to which                                      authorisation
   the marketing
   authorisation has been
   subject and, notably, to
   respect the methods of
   manufacture and
   control;
 Draft new labelling and,
   if specified, instruction
   Package Leaflet;
 Current manufacturing
   authorisation(s);
 A formal document from
   a relevant official body
   (e.g. Chamber of
   Commerce)
 Special cases for
   mergers/acquisitions.
 And, where applicable:
- Reports of the controls
performed by the applicant
with respect for the said
methods;
- The preparation formula,
notably with all useful
indications as to the
recipient;




                                    Notice to Applicants – December 2011                                                         19
                             Transfer of marketing        Change of name and/or           Change of                 Change of name and/or      Co-distribution
                             authorisation holder (art.   address of the marketing        “exploitant” (art.        address of the             (art. R.5121-41 and
                             R 5121-46 of the FPHC)       authorisation holder            R.5121-41 and             “exploitant”(art. R.5121   R.5124-2, 3° of the
                                                                                          R.5124-2, 3° of the       -41 and R.5124-2, 3° of    FPHC)
                                                                                          FPHC)                     the FPHC)
3. Schedule                  Silence after 60 days from   Silence after 30 days from      Silence after 90 days     Silence after 90 days      Silence after 90 days
                             the date of receipt of the   the date of receipt of the      from the date of          from the date of receipt   from the date of receipt
                             application is valid as      application means that the      receipt     of      the   of the application means   of the application means
                             authorisation                holder may make the             application means that    that the holder may make   that the holder may make
                                                          modification                    the holder may make       the modification           the modification
                                                                                          the modification
4. Fees                      € 1011 /NL                   € 1011 for the variation        € 1011 /NL                € 1011 /NL                 € 1011 /NL
                                                          application




5. AFSSAPS unit in charge:   -chemical products           - chemical products             - chemical products       - chemical products        - chemical products
   case monitoring
                             Modification Unit (DEMEB)    Admissibility Unit              Modification Unit         Modification Unit          Modification Unit
                                                          (DEMEB) if national, or         (DEMEB)                   (DEMEB)                    (DEMEB)
                                                          Modification Unit (DEMEB)
                                                          if MRP
                             -biological products         - biological products           - biological products     - biological products      - biological products
                             Unit for Biotechnology-      Admissibility Unit              Unit for Biotechnology-   Unit for Biotechnology-    Unit for Biotechnology-
                             based and Biological         (DEMEB) if national or Unit     based and Biological      based and Biological       based and Biological
                             Medicines (DEMEB)            for Biotechnology-based         Medicines (DEMEB)         Medicines (DEMEB)          Medicines (DEMEB)
                                                          and Biological Medicines
                                                          (DEMEB) if MRP

                             -herbal and homeopathic      - herbal and                    - herbal and              - herbal and               - herbal and
                             medicines:                   homeopathic medicines:          homeopathic               homeopathic                homeopathic
                             Ad Hoc Units (DEMEB)         Ad Hoc Units (DEMEB)            medicines:                medicines:                 medicines:
                                                                                          Ad Hoc Units              Ad Hoc Units (DEMEB        Ad Hoc Units (DEMEB)
                                                                                          (DEMEB)




                                                                Notice to Applicants – December 2011                                                               20
                                 Transfer of marketing        Change of name and/or           Change of                Change of name and/or        Co-distribution
                                 authorisation holder (art.   address of the marketing        “exploitant” (art.       address of the               (art. R.5121-41 and
                                 R 5121-46 of the FPHC)       authorisation holder            R.5121-41 and            “exploitant”(art. R.5121     R.5124-2, 3° of the
                                                                                              R.5124-2, 3° of the      -41 and R.5124-2, 3° of      FPHC)
                                                                                              FPHC)                    the FPHC)
6. Number of copies              3                            3                               3                        3                            3


7. Situation according to        National variation           Depends on the                  National variation       National variation           National variation
   registration procedures                                    registration procedure
                                                              -national or MRP




8. Modification:                 Decision to transfer which   Modification SPC/Package        Modification Package     Modification Package         Modification       Package
   SPC/Package                   impacts the SPC/Package      Leaflet/Labelling               Leaflet /Labelling       Leaflet /Labelling           Leaflet /labelling
   Leaflet/Labelling             Leaflet/Labelling
   (importance for market
   access)

9. Time frame for industrial     Without delay, as far as     Without delay, as far as        Without delay, as far    Without delay, as far as     Without delay, as far as
   installation – in/out phase   possible at the end of the   possible at the end of the      as possible at the end   possible at the end of the   possible at the end of the
                                 calendar (cf. point 3)       calendar (cf. point 3)          of the calendar          calendar (cf. point 3)       calendar (cf. point 3)
                                                                                              (cf. point 3)




                                                                    Notice to Applicants – December 2011                                                                 21
                                                                                                     TABLEAU 6
                       DEPARTMENT OF REGULATORY AFFAIRS AND MANAGEMENT OF MARKETING AUTHORISATION PROCEDURES
                                                                       MANAGER: France Rousselle (33 (0)1 55 87 32 89)
 UNIT FOR MANAGEMENT OF MARKETING AUTHORISATION PROCEDURES AND EUROPEAN LEGISLATION
    Manager: Alban Dhanani 33 (0) 1 55 87 32 95
    Project Managers: distribution by partner and therapeutic class

    Anne Laurent                                           Françoise
  33 (0) 1 55 87 32 80
                             Christelle Véchot                                Julie Duvernois         Annick Njonga           Emilie Alliez        Mathilde Geynet        Mouna Houdon            Sylvie Meheut
                             33 (0) 1 55 87 32 96
                                                            Guyard            33 (0) 1 55 87 33 41   33 (0) 1 55 87 33 07   33 (0) 1 55 87 33 46   33 (0) 1 55 87 33 04   33 (0) 1 55 87 32 90   33 (0) 1 55 87 33 73
                                                       33 (0) 1 55 87 32 85

Cardiology
                             SNC
Converting enzyme                                     SNC
inhibitors (non associated  Anti-epileptic drugs
/in association)            Anti-Parkinson’s drugs    Muscle relaxants
Antiarythmics               Anti-migraine drugs       Anaesthetics
Class I and III             Drugs used in the         Anxiolytics             Cardiology                                                                                                         Ophthalmology
                            treatment of dementia     Antidepressants                                                       Respiratory
Thrombosis                  Anti-psychotics           Psycho-stimulants                              Oncology                                      Antibiotics            Diabetes
                                                                                                                            diseases
                            Botulinum toxins          Drugs used in the       Thrombosis                                                                                                         ENT
Platelet aggregation        Nootropics                treatment of
inhibitors (except heparin) Anti-vertigo drugs        dependence
Enzymes                     Seasickness prevention    Drugs used in the
Streptokinase in            drugs                     treatment of multiple
association                 Analgesia                 sclerosis
                            Hypnotics and sedatives

                                                                                                     Immunology
Diabetes                     Radiopharma-                                                                                                          Anti-virals                                   Blood-derived
(centralised                                          Rheumatology            Antidotes              Haematology            Anti-fungals                                  Gynaecology
                             ceuticals                                                                                                             Anti-fungals                                  products
procedure)                                                                                           Transplants


                                                                                                                            AIDS                                                                 Urology -
                                                                                                                                                   Gastro-
                                                      Stomatology                                    Vaccines               Hepatic diseases                              Endocrinology          Haemodialysis
                                                                                                                                                   enterology


                                                                                                                                                                                                 Orphan
                                                                                                                            Perfuse
                                                                                                                                                                          Dermatology            diseases -
                                                                                                                            solutions
                                                                                                                                                                                                 metabolic
   e-mail: firstname.surname@afssaps.sante.fr (no accents, no cedillas)
         DEMEB, DARP, GESPARE, Distribution by partner and by therapeutic class               Notice to Applicants – December 2011                                                                        22
Demandeur :.............................................................................................................................



              Demande pour engager une Procédure de Reconnaissance Mutuelle
                     avec la France comme Etat membre de référence



                                 NOM DU MEDICAMENT PROPOSE EN FRANCE :
                                                  <>

                                                SUBSTANCE(S) ACTIVE(S) :
                                                         <>


      Procédure                                                    Procédure de Reconnaissance Mutuelle

      Date prévisionnelle soumission
      Classification pharmacothérapeutique,
      code ATC
      Forme pharmaceutique et dosage
      Nombre de demandes / AMM copies
      (duplicates)
      Etats membres concernés
      Base légale de la demande
      Médicament de référence en France
      Date de première autorisation de mise sur le
      marché du médicament de référence en
      France
      Nom et adresse du demandeur
      Personne en charge du dossier au cours de la
      procédure
      Nom et adresse du producteur de substance
      active
      La référence se fera-t-elle à un DMF ou un
      CEP ?
      Fabricant du médicament et site de
      fabrication
      Nom et adresse du fabricant responsable de
      la libération des lots dans l'EEE
      Existe-t-il des autorisations de mise sur le
      marché pour cette substance active dans
      d'autres Etat membres ?
      Si oui, préciser dans quels Etat membres et
      s'il existe des différences majeures entre les
      rubriques 4.1, 4.2 et 4.3 du RCP et celles du
      RCP approuvé en France.
      Joindre la proposition de RCP, si disponible.

Note: ce tableau doit être joint à une lettre officielle de demande pour engager une procédure de
reconnaissance mutuelle ou décentralisée avec la France comme Etat membre de référence.

Attention:
Il est nécessaire que la demande soit confirmée par le laboratoire 6 mois avant la date de soumission
du dossier, précisée par l'AFSSAPS. En l'absence de confirmation, la procédure ne pourra être engagée
dans le délai convenu.




                                                 Notice to Applicants – December 2011
Name of the company: ............................................................................................................



            Request to start a MRP with FRANCE as the Reference Member State



                              PROPOSED NAME OF THE PRODUCT IN FRANCE:
                                                <>

                                             ACTIVE(S) SUBSTANCE(S):
                                                        <>


     Procedure                                                  Mutual Recognition Procedure

     Planned Submission Date
     Pharmacotherapeutic Classification,
     ATC code
     Pharmaceutical Form and Strength
     Number of applications / Duplicates
     Concerned Member States (CMS)
     Legal Basis of Application
     Reference Product in France
     Date of first authorisation of Reference
     Product in France
     Applicant’s Name and Address
     Authorised Contact Person during the
     Procedure
     Name and Address of the Manufacturer of the
     Drug Substance
     Is an ASMF or CEP to be used?
     Manufacturer of the medicinal product and
     site of manufacture
     Name and Address of Manufacturer
     responsible for batch release in the EEA
     Do national MAs exist with this active
     substance in other Member States?
     If yes, please specify in which Member States
     and if there are major differences in Sections
     4.1; 4.2 and 4.3 of the SPCs compared to the
     SPCs approved in France.
     If available, please attached the proposed
     SPC

Note: this table should be annexed to an official cover letter requesting FR to act as the RMS

Warning:
Please note that the request has to be confirmed by the applicant 6 months before the submission date
of the dossier communicated by AFSSAPS. In the absence of confirmation, the beginning of the
procedure should be postponed.




                                              Notice to Applicants – December 2011
                                                 ANNEXE 1-FR
                                   ELECTRONIC SUBMISSION DU DOSSIER

                  Les informations suivantes sont à faire figurer sur la lettre d'accompagnement ;
                                  pour les adresses d'expédition voir chapitre 3.

                                                                   MONSIEUR LE DIRECTEUR
                                                                   AFSSAPS / DEMEB
                                                                   143-147 BOULEVARD ANATOLE FRANCE
                                                                   F-93285 SAINT-DENIS CEDEX
                                                                   FRANCE

                                                                   {Lieu, date}


 Personne en charge du dossier : {Nom, numéro de téléphone et de télécopie; courriel}

 Soumission électronique :
     eCTD
 Numéro de séquence :
     European Non-eCTD electronic Submission (EU-NeeS)


 Objet : {Activité réglementaire} (ex. nouvelle demande ou modification de type II ou renouvellement…)
         {Type de demande} (ex. nouvelle entité chimique ou extension d'indication…)
 Type de procédure:
 Numéro de procédure:
 CMS:


 Monsieur le Directeur,
 Nous avons l'honneur de solliciter une {Activité réglementaire} dans le cadre d'une procédure {type de
 procédure} dont les caractéristiques sont les suivantes :
 Nom du (des) médicament(s) :
 Forme(s) pharmaceutique(s) et dosage (s) :
 DCI/substance(s) actives(s) :
 Code(s) NL* :                                        Code(s) CIS* :
 Code ATC :
 Positionnement de la demande :

 La documentation électronique est organisée conformément à la structure du CTD.
 Nous confirmons que la session de gravure est close et que la soumission a été contrôlée par un antivirus
 à jour {nom de l'antivirus}.

  A l'appui de notre demande, nous vous prions de bien vouloir trouver ci-joint :
   3 copies de la présente lettre ;
   le formulaire pour une soumission électronique ;
   le formulaire d'identification de la demande ;
   le paiement et le bordereau de transmission du paiement ;
   un disque: (ex. module 1 - 5 pour tous les dosages) ;
   un CD complémentaire contenant la proposition d'annexes (I (RCP), II, IIIA (étiquetage) et IIIB (Notice)) (un
         fichier unique par spécialité)* ;
   ...
*S'il y a lieu.


                                          Notice to Applicants – December 2011
                                                 ANNEXE 1-EN
                                 ELECTRONIC SUBMISSION OF THE DOSSIER

       The cover letter should mention the following information. See "chapitre 3" for addresses for sending.



TO THE DIRECTOR GENERAL
AFSSAPS / DEMEB
143-147 BOULEVARD ANATOLE FRANCE
F-93285 SAINT-DENIS CEDEX
FRANCE

                                                                                 {Place, date}


Contact point: {Name, telephone number, fax number, mail}

Electronic submission:
   eCTD
Sequence number:
   European Non-eCTD electronic Submission (EU-NeeS)


RE:    {Regulatory activity} (e.g. new application or type II variation or renewal…)
       {Scope} (e.g. new chemical entity or extension of indication…}
Type of procedure:
Number procedure:
CMS:


Dear Sirs,
We are pleased to submit a {Regulatory activity} for {type of procedure} which details are as follows:
Name of the medicinal product(s):
Pharmaceutical form(s) and strength(s):
INN/active substance(s):
NL code(s)*:                                          CIS code(s)*:
ATC code:
Legal Basis of the Application(s):


The electronic documentation is structured in conformity with the CTD structure.
We confirm that the CD-burning session is closed and the submission is checked with an up-to-date and state-
of-the art virus checker {name of the antivirus}.
 You will find enclosed the following documents/items:
  3 copies of this cover letter
  "AFSSAPS Recommendations for eCTD or EU-NeeS submission" form
  Form of submission identification
  Payment and transmission form for the relevant fees
  One media unit: (e.g. module 1 - 5 for all strengths)
  One additional unit containing the proposition of the SPC, appendix II, Labelling and PIL (one single file for
      each strength)* ;
  ...
*If applicable.
                                          Notice to Applicants – December 2011
                                                ANNEXE 2-FR
                                      PAPER SUBMISSION DU DOSSIER

                 Les informations suivantes sont à faire figurer sur la lettre d'accompagnement ;
                                 pour les adresses d'expédition voir chapitre 3.


                                                                  MONSIEUR LE DIRECTEUR
                                                                  AFSSAPS / DEMEB
                                                                  143-147 BOULEVARD ANATOLE FRANCE
                                                                  F-93285 SAINT-DENIS CEDEX
                                                                  FRANCE

                                                                  {Lieu, date}


 Personne en charge du dossier : {Nom, numéro de téléphone et de télécopie, courriel}

 Objet : {Activité réglementaire} (ex. nouvelle demande ou modification de type II ou renouvellement…)
         {Type de demande} (ex. nouvelle entité chimique ou extension d'indication…)
 Type de procédure :
 Numéro de procédure :
 CMS :


 Monsieur le Directeur,
 Nous avons l'honneur de solliciter une {Activité réglementaire} dans le cadre d'une procédure {type de
 procédure} dont les caractéristiques sont les suivantes :
 Nom du (des) médicament(s):
 Forme(s) pharmaceutique(s) et dosage (s) :
 DCI/substance(s) actives(s) :
 Code(s) NL* :                                       Code(s) CIS* :
 Code ATC :
 Positionnement de la demande :

 Le dossier se compose des volumes et exemplaires suivants :

                    Nombres de volumes                                     Nombre d'exemplaires
      Module 1 : {nombre} volume(s)                                         {Nombre} exemplaires
      Module 2 : {nombre} volume(s)                                         {Nombre} exemplaires
      Module 3 : {nombre} volume(s)                                         {Nombre} exemplaires
      Module 4 : {nombre} volume(s)                                         {Nombre} exemplaires
      Module 5 : {nombre} volume(s)                                         {Nombre} exemplaires

  Nous vous prions de bien vouloir trouver, également, ci-joint :
   3 copies de la présente lettre ;
   le formulaire d'identification de la demande ;
   le bordereau de transmission du paiement ;
   un CD contenant la proposition de RCP, Etiquetage et Notice pour tous les dosages et des fichiers
         au format <Word> / <PDF> correspondant aux modules {numéro des modules} ;
   ...
  Nous vous informons qu'un exemplaire des modules 1, 2 et 3 est adressé simultanément à la Direction des
  Laboratoires et des Contrôles.
  ...
*S’il y a lieu.

                                         Notice to Applicants – December 2011
                                                 ANNEXE 2-EN
                                     PAPER SUBMISSION OF THE DOSSIER

       The cover letter should mention the following information. See "chapitre 3" for addresses for sending.



TO THE DIRECTOR GENERAL
AFSSAPS / DEMEB
143-147 BOULEVARD ANATOLE FRANCE
F-93285 SAINT-DENIS CEDEX
FRANCE

                                                                                    {Place, date}


Contact point: {Name, telephone number, fax number, mail}

RE:    {Regulatory activity} (e.g. new application or type II variation or renewal…)
       {Scope} (e.g. new chemical entity or extension of indication…}
Type of procedure:
Number procedure:
CMS:


Dear Sirs,
We are pleased to submit a {Regulatory activity} for {type of procedure} which details are as follows:
Name of the medicinal product(s):
Pharmaceutical form(s) and strength(s):
INN/active substance(s):
NL code(s)*:                                          CIS code(s)*:
ATC code:
Legal Basis of the Application(s):


The following number of copies has been submitted:

                     Number of binders                                               Copies
       Module 1 : {number} binder(s)                                             {Number} copies
       Module 2 : {number} binder(s)                                             {Number} copies
       Module 3 : {number} binder(s)                                             {Number} copies
       Module 4 : {number} binder(s)                                             {Number} copies
       Module 5 : {number} binder(s)                                             {Number} copies

 In addition, you will find enclosed the following documents/items:
  the cover letter in 3 copies ;
  Form of submission identification;
  Transmission form for the relevant fees ;
  One CD containing SPC, PL and labelling for all strengths and files <Word> / <PDF> corresponding to
       modules {number modules} ;
  ...
 Please be informed that we sent a copy of modules 1, 2 and 3 to the Direction des Laboratoires et des
 Contrôles simultaneously.
 ....
*If applicable.

                                          Notice to Applicants – December 2011
                                                                                        ANNEXE 3

                                                 FORMULAIRE POUR UNE ELECTRONIC SUBMISSION NeeS
                                                                AFSSAPS FORM FOR NeeS SUBMISSION

1. TYPE DE ELECTRONIC SUBMISSION
     e-SUBMISSION TYPE


                                                                      A compléter par le demandeur                                             Réservé
                     NeeS                                                                                                                      Contrôle
                                                                        To be filled by the Applicant                                          Afssaps
    Version utilisée pour établir le
    rapport de validation / Version used           .................................................................................
    to generate the validation report

                                                   Nom/Name ............................................................................................

    Personne en charge de ce NeeS                  Téléphone/Phone .................................................................................
    Contact point for this NeeS                    Télécopie/Fax .......................................................................................
                                                   Courriel/e-mail ......................................................................................

                                                                                                         DVD-R                DVD+R            Réservé
                                                     CD-R            DVD-R            DVD+R              Double-    Double-couche/             Contrôle
    Type de support                                                                                    couche/layer     layer                  Afssaps
    Type of medium
                                                                                                                             
    N° de série du support non
                          3
    réinscriptible (WORM) à reporter
    ci-contre                                      .........................................................................................
    Serial Nr of the non re-writable CD
                        4
    (WORM) to be filled

Modalités : une seule Activité Réglementaire sur un support CD ou DVD unique et non réinscriptible (WORM),
session de gravure close.
Requirements: only one regulatory activity on only one WORM support, CD-burning closed session.


                                                                                A compléter par le demandeur                                   Réservé
                                                                                  To be filled by the Applicant                                Contrôle
                                                                                                                                               Afssaps
    Demandeur/Applicant
    Nom complet de la ou des spécialité(s) (avec
    dosage(s) et forme(s) pharmaceutique(s))
    Full name of the medicinal product(s) (with
    strength(s) and pharmaceutical form(s))
    Date de dépôt/Date of submission
    Substance(s) active(s)/Active substance(s)
    Type de procédure/Type of procedure
    N° de procédure/Procedure Nr
    Activité réglementaire/Regulatory activity



3
  Le numéro de série à reporter est celui inscrit par le fabricant au centre du support. L'étiquette ne doit pas empêcher la lecture du numéro
de série. Ce numéro doit rester visible et lisible.
4
  The serial number to be filled is the one mentioned by the manufacturer in the middle of the medium. The serial number must not been
hidden by the label. This number must be visible and readable.
                                                   Notice to Applicants – December 2011
                                                             A compléter par le demandeur           Réservé
                                                              To be filled by the Applicant         Contrôle
                                                                                                    Afssaps
 Type de demande ou de modification/
 Type of claim
 Code(s) dossier (type NL) (si connu(s))/
 NL Code(s) (if available)
 Date du NeeS (JJ/MM/AAAA)/
 Date of the NeeS (DD/MM/YYYY)

2. COMPLÉTUDE DU DOSSIER
   COMPLETENESS OF THE DOSSIER

                                                         A compléter par le demandeur/ To be        Réservé
                                                               filled by the Applicant              Contrôle
                                                                                                    Afssaps
 Le demandeur atteste que la session est close./
 The applicant certifies that The CD-burning
 session is closed.
 Taille (Mo)/Size (Mo)
 Nombre de répertoires/Number of folders
 Nombre de fichiers/Number of files

3. HISTORIQUE COMPLET DES DÉPÔTS
   COMPLETE HISTORY OF SUBMISSIONS

    Date de dépôt             Dates précédentes               Activité réglementaire / type de demande
  Date of submission                NeeS                         Regulatory activity / Type of claim
                             Previous NeeS dates




4. PÉRENNITÉ DES DONNÉES
   DURABILITY OF THE DATA

L'ensemble des données du dossier est à déposer sur un support unique. The Application must be submitted as
one single copy
Le disque doit être non réinscriptible (WORM) : CD-R, DVD-R ou DVD+R, éventuellement double-couche.
La session de gravure doit être close. / Each medium must be WORM: CD-R, DVD-R or DVD+R or DVD-R
double-layer or double-layer DVD+R. The CD-burning session is closed.
Préciser / Specify :
  taille du dossier / size of the dossier < 650 Mo                : un seul et unique CD-R / only one CD-R

    taille du dossier / size of the dossier  650 Mo et < 4,7 Go : un seul et unique DVD-R / DVD+R
                                                                    only one DVD-R / DVD+R
    taille du dossier / size of the dossier  4,7 Go et < 8,5 Go : un seul et unique DVD-R / DVD+R double
     couche                                                         only one DVD-R / DVD+R double layer

5. LOGICIELS
   SOFTWARES

6.A Création du NeeS / Generation of the NeeS             6.B Antivirus
    - Nom du logiciel / Name of the software :                - Nom du logiciel / Name of the software :
    - Version / Version :                                     - Version / Version :
    - Société / Society :                                     - Société / Society :




                                        Notice to Applicants – December 2011
                                                                                        ANNEXE 4

                                                 FORMULAIRE POUR UNE ELECTRONIC SUBMISSION eCTD
                                                               AFSSAPS FORM FOR eCTD SUBMISSION

1. TYPE DE ELECTRONIC SUBMISSION
     e-SUBMISSION TYPE


                                                                      A compléter par le demandeur                                             Réservé
                     eCTD                                                                                                                      Contrôle
                                                                        To be filled by the Applicant                                          Afssaps
    Version utilisée pour établir le
    rapport de validation / Version used           .................................................................................
    to generate the validation report

                                                   Nom/Name ............................................................................................

    Personne en charge de cet eCTD                 Téléphone/Phone. ................................................................................
    Contact point for this eCTD                    Télécopie/Fax .......................................................................................
                                                   Courriel/e-mail ......................................................................................

                                                                                                         DVD-R                DVD+R            Réservé
                                                     CD-R            DVD-R            DVD+R              Double-    Double-couche/             Contrôle
    Type de support                                                                                    couche/layer     layer                  Afssaps
    Type of medium
                                                                                                                             
    N°(s) de série du support non
                             5
    réinscriptible(s) (WORM) à reporter
    ci-contre                                      .........................................................................................
    Serial Nr(s) of the non re-writable
                             6
    CD (WORM) to be filled

Modalités : une seule Activité Réglementaire (= une seule séquence pour un eCTD) par support CD ou DVD
non réinscriptible (WORM), session de gravure close.
Requirements: only one regulatory activity per WORM support, CD-burning closed session.


                                                                                A compléter par le demandeur                                   Réservé
                                                                                  To be filled by the Applicant                                Contrôle
                                                                                                                                               Afssaps
    Demandeur/Applicant
    Nom complet de la ou des spécialité(s) (avec
    dosage(s) et forme(s) pharmaceutique(s))
    Full name of the medicinal product(s) (with
    strength(s) and pharmaceutical form(s))
    Date de dépôt/Date of submission
    Substance(s) active(s)/Active substance(s)
    Type de procédure/Type of procedure
    N° de procédure/Procedure Nr
    Activité réglementaire/Regulatory activity



5
  Le numéro de série à reporter est celui inscrit par le fabricant au centre du support. L'étiquette ne doit pas empêcher la lecture du numéro
de série. Ce numéro doit rester visible et lisible.
6
  The serial number to be filled is the one mentioned by the manufacturer in the middle of the medium. The serial number must not been
hidden by the label. This number must be visible and readable.
                                                   Notice to Applicants – December 2011
                                                               A compléter par le demandeur          Réservé
                                                                To be filled by the Applicant        Contrôle
                                                                                                     Afssaps
 Type de demande ou de modification/
 Type of claim
 Code(s) dossier (type NL) (si connu(s))/
 NL Code(s) (if available)
 N° de Séquence / Sequence Nr

2. COMPLÉTUDE DU DOSSIER
   COMPLETENESS OF THE DOSSIER

                                                           A compléter par le demandeur/ To be       Réservé
                                                                 filled by the Applicant             Contrôle
                                                                                                     Afssaps
 Le demandeur atteste que la session est close/
 The applicant certifies that the CD-burning
 session is closed.
 Taille (Mo) / Size (Mo)
 Nombre de répertoires/Number of folders
 Nombre de fichiers/Number of files
 Clef MD5/MD5 checksum

3. HISTORIQUE COMPLET DES DÉPÔTS
   COMPLETE HISTORY OF SUBMISSIONS

    Date de dépôt              N° de séquence                   Activité réglementaire / type de demande
  Date of submission          Sequence number                      Regulatory activity / Type of claim




4. PÉRENNITÉ DES DONNÉES
   DURABILITY OF THE DATA

L'ensemble des données du dossier est à déposer sur un support unique. The Application must be submitted as
one single copy
Le disque doit être non réinscriptible (WORM) : CD-R, DVD-R ou DVD+R, éventuellement double-couche.
La session de gravure doit être close. / Each medium must be WORM: CD-R, DVD-R or DVD+R or DVD-R
double-layer or double-layer DVD+R. The CD-burning session is closed.
Préciser / Specify :
  taille du dossier / size of the dossier < 650 Mo                  : un seul et unique CD-R /
                                                                       only one CD-R
    taille du dossier / size of the dossier  650 Mo et < 4,7 Go : un seul et unique DVD-R / DVD+R
                                                                    only one DVD-R / DVD+R
    taille du dossier / size of the dossier  4,7 Go                : un ou plusieurs DVD-R / DVD+R double
     couche
                                                                       one or more DVD-R / DVD+R double layer

5. LOGICIELS
   SOFTWARES

6.A Création du eCTD / Generation of the eCTD               6.B Antivirus
    - Nom du logiciel / Name of the software :                  - Nom du logiciel / Name of the software :
    - Version / Version :                                       - Version / Version :
    - Société / Society :                                       - Société / Society :



                                          Notice to Applicants – December 2011
                          ANNEXE 5
      MENTIONS A FAIRE FIGURER SUR LE DISQUE
     REFERENCES TO REPRODUCE ON THE MEDIUM

             Cas d'un EU-NeeS /For EU-NeeS




                             DCI / INN
              Nom du produit / Name of the medicinal
                               product
                     Code ATC / ATC Code

                                                EU-NeeS

Nom et adresse du
demandeur / Applicant's
name and address                                Date de soumission /
                                                Submission date
                                                  JJ/MM/AAAA


                    Activité Réglementaire /
                       Regulatory activity

                N° de procédure / Procedure Nr.




               Notice to Applicants – December 2011
                          ANNEXE 6
       MENTIONS A FAIRE FIGURER SUR LE DISQUE
      REFERENCES TO REPRODUCE ON THE MEDIUM

                  Cas d'un eCTD/For eCTD




                              DCI / INN
              Nom du produit / Name of the medicinal
                                product
                      Code ATC / ATC Code

                                                   eCTD

Nom et adresse du                            Séquence / sequence - - - -
demandeur / Applicant's
name and address                                Date de soumission /
                                                Submission date
                                                  JJ/MM/AAAA

                     Activité Réglementaire /
                        Regulatory activity

                 N° de procédure / Procedure Nr.




                Notice to Applicants – December 2011
                          ANNEXE 7
      MENTIONS A FAIRE FIGURER SUR LE DISQUE
     REFERENCES TO REPRODUCE ON THE MEDIUM

  Cas du CD complémentaire (RCP/Notice/étiquetage)
       For additional CD (SmPC/PIL/Labelling)




                             DCI / INN
             Nom du produit / Name of the medicinal
                               product
                     Code ATC / ATC Code
                                                 Proposition
                                            RCP/Notice/Etiquetage /
                                              SmPC/PIL/Labelling
Nom et adresse du                           Template 7 - Word FStyle
demandeur / Applicant's
name and address                               Date de soumission /
                                               Submission date
                                                 JJ/MM/AAAA

                    Activité Réglementaire /
                       Regulatory activity

                N° de procédure / Procedure Nr.




               Notice to Applicants – December 2011
                                                                   ANNEXE 8-FR
                                FORMULAIRE D'IDENTIFICATION DE LA DEMANDE
                              dûment complété à joindre à toute soumission de dossier
                                             dans le cadre de l'AMM

NOM DU PRODUIT ....................................................................................................................................................................

NOM DU LABORATOIRE: ..................................................................................................................................

Personne à contacter :
TYPE DE PROCEDURE                                                Numéro de procédure                          Numéro(s) NL                Numéro CIS
                                                                                                              (ou EH)
     Centralisée (PC)
     Reconnaissance mutuelle (PRM)
     Décentralisée (PDC)
     Nationale
CODE ATC

TYPE DE DOSSIER
          Nouvelle demande d’AMM                            Changement d’exploitant
          Modification de type IA                           Renouvellement
          Modification de type IB                           Renouvellement biennal
          Modification de type II                           Obligation spécifique – réévaluation annuelle
          Extension d’indications                           Mesure de suivi
          Transfert d’AMM                                   Rapports de pharmacovigilance
          Changement de raison sociale / d’adresse du       Enregistrement Homéopathie
      titulaire                                             Autres (préciser) :       .
          Complément de dossier dans le cadre d’une Nom de la personne en charge du dossier à
     procédure mentionnée ci-dessus                   l’AFSSAPS (pour les dépôts faisant suite à une
                                                      demande de l’AFSSAPS)
     Préciser :                .

          Dossier de réponse à une procédure
     contradictoire dans le cadre d’une procédure
     mentionnée ci-dessus
     Préciser :           .

          Dossier demandé par la personne en charge
          du dossier à l’AFSSAPS
       Recours gracieux dans le cadre d’une TAXES
     procédure mentionnée ci-dessus               Chèque
TYPE DE PRODUIT                                     Virement bancaire (préciser le nom de la
      Chimique                                 banque, la date et le numéro du virement) :
      Biologique                            Toutes les rubriques relatives au payeur, dans
      Générique                             le Bordereau de Transmission du Paiement
      Radio-pharmaceutique                  (annexe 9) doivent être complétées
      Homéopathique                         impérativement.
      Plantes – Phytothérapie               Le cas échéant, toutes les informations devant
      Prescription Médicale Facultative     figurer sur l’avis du virement, précisées au
      Autres (préciser) :                   chapitre 3.2. doivent systématiquement être
                                                                                   renseignées.

                      Dossier à adresser à l'AFSSAPS - DEMEB - DORIS - Unité Recevabilité AMM
                            143/147 Boulevard Anatole France - F-93285 Saint-Denis Cedex
                             ou à déposer de 9h à 11h30 et de 14h à 16h30 du lundi au vendredi

                                                        Notice to Applicants – December 2011
                                                               ANNEXE 8-EN

                                   FORM OF SUBMISSION IDENTIFICATION to fill and
                                  append to any correspondence or submission in the
                                                    context of MA
NAME OF THE PRODUCT .................................................................................................................................

NAME OF THE PHARMACEUTICAL COMPANY

Contact person:
TYPE OF PROCEDURE                                            Procedure number                          NL number(s)               CIS number(s)
                                                                                                       (or EH)
     Centralised (CP)
     Mutual Recognition (MRP)
     Decentralised (DCP)
     National
ATC CODE

TYPE OF DOSSIER
        New application for marketing authorisation                                     Change of distributor
        Type IA variation                                                               Renewal
        Type IB variation                                                               Two-yearly renewal
        Type II variation                                                               Specific obligation–annual revaluation
        Extension of indications                                                        Follow-up measure
        MA Transfer                                                                     Pharmacovigilance report
        Change of company name/ address of the                                          Homeopathic registration
      holder                                                                            Other (specify):      .
        Additional documentation within the                                   Nom de la personne en charge du dossier à
    framework of the above-mentioned procedure                                l’AFSSAPS (pour les dépôts faisant suite à une
                                                                              demande de l’AFSSAPS)
    Specify:               .

       Written response to a “contradictory”
    procedure within the framework of the above-
    mentioned procedure
    Specify:           .

        Dossier requested by the person in charge
    of the dossier at AFSSAPS
                                                                              FEES
          "Recours gracieux" within the above-
         mentioned procedure
                                                                                      Cheque
TYPE OF PRODUCT                                                                       Bank transfer (specify the name of the bank and
     Chemical                                                                     the date of the transfer):
     Biological
     Generic                                                                  All sections related to the Paying company in
     Radio-pharmaceutical                                                     the Transmission form (annexe 9) must be
                                                                              fully completed.
     Homeopathic
     Herbals – Herbal medicines                                               Where appropriate, all information to be
     Self-medication                                                          specified on the notification of transfer, (see
                                                                              section 3.2.) must be systematically filled.
     Other (specify :

                        Dossier to be sent to AFSSAPS - DEMEB - DORIS - Unité Recevabilité AMM
                             143/147 Boulevard Anatole France - F-93285 Saint-Denis Cedex
                   or to be submitted from Monday to Friday: 9.00 to 11.30 a.m. and 2.00 to 4.30 p.m.
                                                     Notice to Applicants – December 2011
                                                               VALID FOR APPLICATIONS RECEIVED BY AFSSAPS
                                    ANNEXE 9-FR                UNTIL 31-12-2011.

                                                  BORDEREAU DE TRANSMISSION DU PAIEMENT
                                     À L’AGENCE FRANÇAISE DE SÉCURITÉ SANITAIRE DES PRODUITS DE SANTÉ

SI NOUVELLE DEMANDE D’AMM :
  NOM ET ADRESSE DE LA FIRME DEMANDEUR DE L’AMM :
     NOM ET COORDONNEES (TELEPHONIQUE ET/OU MAIL) DE LA PERSONNE RESPONSABLE DU DOSSIER :

  NOM ET ADRESSE DU PAYEUR :
     NOM ET COORDONNEES (TELEPHONIQUE ET/OU MAIL) DE LA PERSONNE RESPONSABLE DU DOSSIER :

  NOM DE LA SPECIALITE / DOSAGE :
  NUMERO DE LA PROCEDURE (SI PROCEDURE EUROPEENNE) :
SI MODIFICATION OU RENOUVELLEMENT D’AMM :
  NOM ET ADRESSE DE LA FIRME TITULAIRE DE L’AMM :
     NOM ET COORDONNEES (TELEPHONIQUE ET/OU MAIL) DE LA PERSONNE RESPONSABLE DU DOSSIER :

  NOM ET ADRESSE DU PAYEUR :
     NOM ET COORDONNEES (TELEPHONIQUE ET/OU MAIL) DE LA PERSONNE RESPONSABLE DU DOSSIER :

  NOM DE LA SPECIALITE / DOSAGE(S) :
  CODE DOSSIER TYPE NL DE TOUTES LES AMM CONCERNEES :
  NUMERO DE LA PROCEDURE (SI PROCEDURE EUROPEENNE) :
                                                                                                            Cocher la ou les cases
AMM                                                                                        EUROS              correspondantes
             1 Dossier complet                                                                     25 400            
             2 Dosage ou forme pharmaceutique supplémentaire présenté
               simultanément à la première demande d’autorisation                                  12 700            
             3 Nouvelles indications thérapeutiques                                                16 790            
             4 Nouvelles voies d’administration                                                    16 790            
             5 Nouvelles associations                                                              16 790            
             6 Usage thérapeutique bien établi (référence à la littérature scientifique)           16 790            
             7 Dosage ou forme pharmaceutique supplémentaire présenté
               simultanément à la première demande d’autorisation et relevant des
               points 3,4,5,6 ci-dessus                                                             8 395            
             8 Génériques                                                                          10 110            
             9 Nouvelles formes pharmaceutiques                                                    10 110            
            10 Nouveaux dosages (1 dossier par dosage)                                             10 110            
            11 Médicaments à base de plantes                                                       10 110            
            12 Allergènes                                                                          10 110            
            13 Modification                                                                         1 011            
            14 Renouvellement                                                                         674            
TAXE PERCUE POUR TOUTE DEMANDE D’IMPORTATION PARALLÈLE
               Demande d’autorisation                                                               5 000            
               Renouvellement                                                                         674            
PUBLICITÉ
               Dépôt                                                                                 510             
               Visa GP                                                                               510             
               Visa PR (préservatifs)                                                                510             
               Visa PP (publicité produits)                                                          510             

INTITULE DE LA BANQUE :………………………………………………………………………...
 CHEQUE DATE ET N°……………………………………………………………………………
 VIREMENT DATE ET N° …………………………………………………………………………
JOINDRE OBLIGATOIREMENT L’AVIS DE VIREMENT COMPORTANT LES MENTIONS PREVUES AU POINT 3.2 PAGE 12

ENREGISTREMENT                                                Signature du responsable :
(à remplir par l’Administration)




                                              Notice to Applicants – December 2011
                                    ANNEXE 9-EN                   VALID FOR APPLICATIONS RECEIVED BY AFSSAPS
                                                                  UNTIL 31-12-2011.

                                                                TRANSMISSION FORM
                                                     TO AGENCE FRANÇAISE DE SÉCURITÉ SANITAIRE
                                                         DES PRODUITS DE SANTÉ (AFSSAPS)
IN CASE OF NEW APPLICATION:
  NAME AND ADDRESS OF THE APPLICANT:
    NAME AND ADDRESS AND PHONE NUMBER (AND/OR E-MAIL) OF THE PERSON IN CHARGE OF THE DOSSIER:
  NAME AND ADDRESS OF THE PAYING COMPANY:
    NAME AND ADDRESS AND PHONE NUMBER (AND/OR E-MAIL) OF THE PERSON IN CHARGE OF THE DOSSIER:
  NAME OF THE PRODUCT / STRENGTH:
  NUMBER PROCEDURE (IF EUROPEAN PROCEDURE):
IN CASE OF MODIFICATION OR RENEWAL:
  NAME AND ADDRESS OF THE HOLDER:
    NAME AND ADDRESS AND PHONE NUMBER (AND/OR E-MAIL) OF THE PERSON IN CHARGE OF THE DOSSIER:
  NAME AND ADDRESS OF THE PAYING COMPANY:
    NAME AND ADDRESS AND PHONE NUMBER (AND/OR E-MAIL) OF THE PERSON IN CHARGE OF THE DOSSIER:
  NAME OF THE PRODUCT / STRENGTH(S):
  NL CODE OF ALL CONCERNED MARKETING AUTHORISATIONS:
  NUMBER PROCEDURE (IF EUROPEAN PROCEDURE):

AMM                                                                                              EUROS       Should be completed where
                                                                                                                            appropriate
             1 Full application                                                                   25 400             
             2 Additional strength or pharmaceutical form submitted at the same time as
                the initial application for authorisation                                         12 700             
             3 Extension of therapeutic indications                                               16 790             
             4 New route of administration                                                        16 790             
             5 New combinations                                                                   16 790             
             6 Well established use application (bibliographical application)                     16 790             
             7 Additional strength or pharmaceutical form submitted at the same time as
                the initial application for authorisation mentioned in points 3,4,5,6 above        8 395             
             8 Generic application                                                                10 110             
             9 New pharmaceutical forms                                                           10 110             
            10 New strengths (1 dossier per strength)                                             10 110             
            11 Herbal medicinal product                                                           10 110             
            12 Allergens                                                                          10 110             
            13 Variation                                                                           1 011             
            14 Renewal                                                                               674             
FEE FOR PARALLE IMPORTATION
                New application                                                                    5 000             
                Renewal                                                                              674             
ADVERTISING
                Submission                                                                           510             
                Visa GP                                                                              510             
                Visa PR (codoms)                                                                     510             
                Visa PP (product advertising)                                                        510             

BANK REFERENCE:………………………………………………………………………...
 CHEQUE: DATE AND No.……………………………………………………………………………
 BANK TRANSFER: DATE AND No …………………………………………………………………………

VISA                                                          Signature of the person in charge of the dossier:
(to be filled by AFSSAPS)




                                              Notice to Applicants – December 2011
                                                               ANNEXE 10-NeeS


                                       SWITCH OF TYPE OF SUBMISSION IN POST-AMM




       Submission in
        NeeS format
    is ACCEPTED ONLY
    in the context of the
    following regulatory
          activities:

 new applications

 type II variations

 PSUR

 renewals

 start of MRP with France
  as RMS or "Repeat use"
  in MRP or DCP




  No switch of medium
  (Paper / NeeS / eCTD)
  Possibility to switch
  from:
     Paper to Nees
     Paper to eCTD
     NeeS to eCTD

  In case you switch, it is
impossible to change back.




                                              STRUCTURE NeeS
               1 general folder containing:
                 1 general TOC - 1 TOC per module (optional) - 5 modules

               Specifications are available on the website:
                http://esubmission.emea.europa.eu/doc/eGuidance_Document_1.4.pdf




                                      Notice to Applicants – December 2011
                                                               ANNEXE 10- eCTD

                                         SWITCH OF TYPE OF SUBMISSION IN POST-AMM




       Submission in
        eCTD format
    is ACCEPTED ONLY
    in the context of the
    following regulatory
          activities:

 new applications

 type II variations

 PSUR

 renewals

 start of MRP with France
  as RMS or "Repeat use"
  in MRP or DCP

  Any further applications
should be submitted in eCTD
           format



  No switch of medium
  (Paper / NeeS / eCTD)
  Possibility to switch
  from:
     Paper to Nees
     Paper to eCTD
     NeeS to eCTD

   In case you switch, it is
 impossible to change back.



                                              STRUCTURE eCTD
               1 general folder containing:
                  1 index.xml – 1 index-md5.txt - 5 modules – 1 folder « util »

               Specifications are available on the website:
                http://esubmission.emea.europa.eu/doc/eGuidance_Document_1.4.pdf




                                         Notice to Applicants – December 2011
Notice to Applicants – December 2011

				
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