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The Role of the Patented Medicine Prices Review Board Over the Counter

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The Role of the Patented Medicine Prices Review Board Over the Counter Powered By Docstoc
					 Patented Medicines Regulations
 Review of Reporting Changes

Ginette Tognet, Béatrice Mullington & Marc Legault
Compliance and Enforcement Branch

Montréal, Québec                    Toronto, Ontario
May 27, 2008                        June 3, 2008
    Objectives
     Overview of amendments to the Patented Medicines
        Regulations, 1994
       Changes to Form 1
       Step by step review of Form 1
       Changes to Form 2
       Step by step review of Form 2
       Other reporting issues
       Questions

2
    Patented Medicines Regulations
     Amendments made to Patented Medicines Regulations, 1994
     The Patented Medicines Regulations (Regulations) were
      registered on March 6, 2008 and published in the Canada
      Gazette, Part II, March 19, 2008
     The Regulations are available from the PMPRB Web site under
      “Legislation, Regulations, Guidelines”




3
    Overview of Changes
     Product Monograph or information similar to that contained in
        a product monograph must be submitted along with Form 1
       Price and sales data for first day of sale within 30 days after
        that day (replaces first 30-day sales)
       Complaints driven process for patented veterinary and over-
        the-counter drug products
       All data to be submitted to PMPRB required to be done in
        electronic format
       Recognition of electronic signatures
4
    Overview of Changes
     Timing for filing of Form 1 is now 7 days following issuance of
      Notice of Compliance (NOC) or date of first sale, whichever
      comes first
     No change in timing for reporting Form 2 information for each six-
      month period, continues to be 30 days following the end of each
      period
     Changes are in force now, except for the requirement to file
      electronically



5
    Electronic Reporting
     Section 7 of the Regulations was replaced by the following:
        Every person required by these Regulations to provide information to
         the Board shall do so using the appropriate electronic document made
         available on the Board’s website and by sending the completed
         electronic document, in its original format and file type, to the email
         address specified by the Board on its website.




6
    Electronic Reporting
     Electronic filing required for Forms 1, 2 and 3
          Completed forms must be sent to: compliance@pmprb-cepmb.gc.ca
     Electronic signature
          Electronic reproduction of manual signature of authorized person
           required by the Board
     Form 2
        PMPRB electronic verification system will check submitted Form 2
         information for incompleteness
        Company will be informed of missing data and will be asked to resubmit
         corrected Form 2
7
    Electronic Reporting
     Electronic filing required for Forms 1, 2 and 3




8
    FORM 1 and FORM 2
     The next part of the presentation will be a step by step review
     of Form 1 and Form 2.




9
     Form 1 – Medicine Identification Sheet

      Change in timing of filing Form 1
          Within 7 days after issuance of an NOC, or first sale in Canada, whichever
           comes first
      New information to be provided
          Indicate whether drug product is Human prescription, Human over-the-
           counter or Veterinary
          Date of first sale
          Product monograph if NOC is granted; if NOC not granted, information
           similar to product monograph


10
     Patented Medicine                                          FORM 1                                                                                         Privileged s.87
     Prices Review Board                            MEDICINE IDENTIFICATION SHEET                                                                                   Patent Act


                                                                  Use one form per DIN                                                                       Page 1 of 2

                                Please Specify       Original Filing   or                       Amendment to Original Filing

     1 NAME(S) AND USE(S) OF THE MEDICINE

     Brand Name:

     Generic Name:


     Therapeutic use(s) of the medicine

     approved by Health Canada:



                                                               (The medicine is for human use and contains a controlled substance as defined in the               Controlled
                           Human Prescription                  Drugs and Substances Act      or contains a substance listed or described in Schedules C or D to the
                                                               Food and Drugs Act or in Schedule F to the       Food and Drug Regulations         )
                                  OR

                                                               (The medicine is for human use and does not contain a controlled substance as defined in the
                           Human Over-the-Counter              Controlled Drugs and Substances Act       or does not contain a substance listed or described in
                                                               Schedules C or D to the    Food and Drugs Act or in Schedule F to the         Food and Drug Regulations         )

                                  OR

                           Veterinary




11
     2 REPORTING PATENTEE
     Patentee Name
     Patentee Address




     Identity if the reporting
     patentee is:                    the patent holder       person entitled to the benefits of a patent or to exercise any rights in relation to a patent




     3 NOTICE OF COMPLIANCE (N.O.C.)


     First N.O.C.                                        Check if                       Special Access Programme
              Y                  M       D               applicable                     or
                                                                                        Clinical Trial Application or Investigational New Drug


     4 DRUG IDENTIFICATION NUMBER (DIN)



     Drug Identification Number                                            Dosage Form                                               Strength/Unit




     5 DATE OF FIRST SALE                                6 PRODUCT MONOGRAPH

             st
     Date of 1 Sale                                                          Product Monograph OR                       Information similar to that
                                                                                                                        contained in a Product
              Y                  M       D                                                                              Monograph
                                                                             (Copy Included)
                                                                                                                        (Copy Included)


12
     7 PATENT NUMBER OF REPORTING PATENTEE'S INVENTIONS PERTAINING TO THE MEDICINE


                                                             Date Granted                         Expiration Date
                    Patent Number
                                                         Y             M       D              Y              M        D

                                                         Y             M       D              Y              M        D



                                                         Y             M       D              Y              M        D



                                                         Y             M       D              Y              M        D



                                                         Y             M       D              Y              M        D




                   (in
     8 CERTIFIED BY: accordance with Section 7 of the Patented Medicines Regulations)
                                               I hereby certify that the information presented is true and correct.

     Signature of duly authorized person for the reporting patentee.

     Name:

     Title:

     Organization:

     Date:

     Tel. Number:    (         )                     -                          Fax Number : (           )                -

     E-mail:

13
     Form 2 – Information on the Identity and
     Prices of the Medicine
      Change in period covered
           Human prescription drug: when drug is first offered for sale in Canada,
            data for first day of sale must be provided no later than thirty (30) days after
            the date of first sale
      Change in timing of filing
         OTC drugs and drugs for veterinary use: information must be provided
          within 30 days after the date on which the Board sends a request, and during
          the two (2) years following the request, within 30 days after each six-month
          period.



14
     Patented Medicine                                 FORM 2                            Privileged s.87
     Prices Review Board          INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE     Patent Act


                                                   Use one form per medicine or per DIN
                                                                                                                        Page   1       of



                             Please Specify          Original Filing      or      Amendment to Original Filing



     1 REPORTING PERIOD

     Period to which the                                             FROM                                         TO
                                                             Y              M         D                  Y             M           D
     information applies:




     2 NAMES OF THE MEDICINE

     Brand name of the medicine
     Generic name of the medicine


     3 REPORTING PATENTEE*
     Patentee Name

     Patentee Address




                                    Patent Act for the definition of a "patentee". Note that a patentee is any person entitled
     *Please see section 79(1) of the
     to the benefits of a patent or to exercise any rights in relation to a patent. This includes patent holders, licensees or others.

15
     CERTIFIED BY:(in accordance with Section 7 of the Patented Medicines Regulations)

                                            I hereby certify that the information presented is true and correct.

     Signature of duly authorized person for the reporting patentee


     Name:
     Title:

     Organization:

     Date:

     Tel. Number: (           )                      -                          Fax Number : (           )         -

     E-mail:




16
     Patented Medicine                                                   FORM 2(continued)                                                     Privileged s.87
     Prices Review Board                                       INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                              Patent Act


     Reporting period:

                                                                                  1
     4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA
       Drug Identification
       Number (DIN) or       Strength/Unit3                             Number of          INDICATE EITHER   6
                                              Dosage     Package                                                                     Prov. 4     Class of
                     2                                                Packages Sold5
       Assigned Number                        Form 3,4    Size 3, 5                    Net Revenue               AVG Price/Package              Customer4




     (1) Each line of information should be fully completed to include DIN or Assigned Number, Strength/Unit, Dosage Form, Package Size, Number of Packages
      Sold, Net Revenues, Average Price/Package, Province, Class of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) Insert only numeric values
     (6) Please provide net revenue whenever possible, otherwise provide the average price per package

17
     Patented Medicine                                                         FORM 2 (continued)                                                             Privileged s.87
     Prices Review Board                                     INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                               Patent Act


                           Reporting period:

                                                                       1
     5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES

                                                 Corresponding Canadian Drug
                                               Identification Number (DIN) when                       Dosage                      Ex - Factory   Country or     Class of
            Generic name of medicine                                              Strength / Unit 3              Package Size 3
                                                  sold in Canada, or Assigned                         Form 3,4                                    Prov. 4      Customer 4
                                                            Number 2                                                                Price 5




     (1) Each line of information should be fully completed to include Generic Name, DIN, Strength/Unit, Dosage Form, Package Size, Ex-Factory Price, Country or Province, Class
     of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) In currency of the country in which the medicine is sold

18
     Sample of correctly completed Form 2,
                    Block4
     Patented Medicine                                                      FORM 2 (continued)                                                          Privileged s.87
     Prices Review Board                                          INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                    Patent Act


     Reporting period:

     4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1
        Drug Identification
        Number (DIN) or       Strength/Unit 3                             Number of           INDICATE EITHER   6
                                                Dosage     Package                                                                          Prov. 4        Class of
                          2                                             Packages Sold 5
       Assigned Number                          Form 3,4    Size 3, 5                     Net Revenue               AVG Price/Package                     Customer 4
                  7000001 50 MG/TAB             S1                 10         849                 306665                                            1                  1
                  7000001 50 MG/TAB             S1                 20          50                  18500                                            1                  3
                  7000001 50 MG/TAB             S1               100           14                   4290                                            6                  4
                  7000001 50 MG/TAB             S1                 10         849                 306665                                            1                  1
                  7000001 50 MG/TAB             S1                 10         849                 306665                                            1                  1
                  7000002 10 MG/CAP             S2               100           14                   4290                                            1                  4
                  7000004 1 MG/ML               J1               300            4                   1498                                            2                  4
                  7000004 1 MG/ML               J1               600            2                   8754                                           11                  4
                  7000005 1 MG/ML               L1                1.5         176                  61780                        351.0227           12                  1
                  7000005 1 MG/ML               L1                2.5           2                  27534                                            2                  2
                  7000006 1 MG/ML               L1                 20          18                   6080                                            3                  2
                  7000006 1 MG/ML               Y1                 20        2130                 756900                                            3                  3
                  7000006 1 MG/ML               Y1               100          335              875237.00                                           13                  1
     (1) Each line of information should be completed to include DIN or Assigned Number, Strength/Unit, Dosage Form, Package Sise, Number of Packages
      Sold, Net Revenues, Average Price/Package, Province, Class of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) Insert only numeric values
     (6) Please provide net revenue whenever possible, otherwise provide the average price per package


19
     Company ZZZ filing Form 2, Block4
     Patented Medicine                                                          FORM 2 (continued)                                                      Privileged s.87
     Prices Review Board                                              INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                Patent Act


     Reporting period:

     4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1
        Drug Identification
        Number (DIN) or          Strength/Unit 3                               Number of           INDICATE EITHER   6
                                                    Dosage     Package                                                                       Prov. 4       Class of
                          2                                                  Packages Sold 5
       Assigned Number                              Form 3,4    Size 3, 5                      Net Revenue               AVG Price/Package                Customer 4
                   7000001    50 MG/TAB            S1                   10    849                 306665                                            1                1
                    700000    50 MG/TAB            S1                   20     50                  18500                                            1                3
                   7000001    10 MG/CAP            S1                 100      14                   4290                                            6                4
                   7000001    50 MG/TAB            S1                   10    849                 306665                                            1                1
                   7000001    50 MG/TAB            S1                   10    849                 306665                                            1                1
                   7000002                         S2                 100      14                   4290                                            1                4
                   7000004  1 MG/ML                J1                 300       4                   1498                                           21                4
                   7000004  1 MG/ML                J10                600       2                        s                                         11                4
                   7000005  1 MG/ML                L1                  1.5    176                                               351.0227           12                1
                   7000005  1 MG/ML                                    2.5      2                  27534                                                             2
                   7000006  1 MG/ML             L1                             18                   6080                                            3              2,0
                            1 MG/ML             Y1                20         2130                 756900                                            3                 ,
                  7000006 1 MG/ML               Y1               100          335                                                                  13                1
     (1) Each line of information should be completed to include DIN or Assigned Number, Strength/Unit, Dosage Form, Package Sise, Number of Packages
      Sold, Net Revenues, Average Price/Package, Province, Class of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) Insert only numeric values
     (6) Please provide net revenue whenever possible, otherwise provide the average price per package

20
     Company ZZZ filing Form 2, Block4
      Patented Medicine                                                      FORM 2 (continued)                                                        Privileged s.87
      Prices Review Board                                          INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                    Patent Act


      Reporting period:

      4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1
         Drug Identification
         Number (DIN) or       Strength/Unit 3                             Number of           INDICATE EITHER   6
                                                 Dosage     Package                                                                          Prov. 4      Class of
                           2                                             Packages Sold 5
        Assigned Number                          Form 3,4    Size 3, 5                     Net Revenue               AVG Price/Package                   Customer 4
                   7000001 50 MG/TAB             S1                 10         849                 306665                                            1                1
                    700000 50 MG/TAB             S1                 20          50                  18500                                            1                3
                   7000001 10 MG/CAP             S1               100           14                   4290                                            6                4
                   7000001 50 MG/TAB             S1                 10         849                 306665                                            1                1
                   7000001 50 MG/TAB             S1                 10         849                 306665                                            1                1
                   7000002                       S2               100           14                   4290                                            1                4
                   7000004 1 MG/ML               J1               300            4                   1498                                           21                4
                   7000004 1 MG/ML               J10              600            2                        s                                         11                4
                   7000005 1 MG/ML               L1                1.5         176                                               351.0227           12                1
                   7000005 1 MG/ML                                 2.5           2                  27534                                                             2
                   7000006 1 MG/ML               L1                             18                   6080                                            3 2,0
                             1 MG/ML             Y1                 20        2130                 756900                                            3,
                   7000006 1 MG/ML               Y1               100          335                                                                  13                1
      (1) Each line of information should be completed to include DIN or Assigned Number, Strength/Unit, Dosage Form, Package Sise, Number of Packages
       Sold, Net Revenues, Average Price/Package, Province, Class of Customer
      (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
      (3) Use a separate line for each strength/unit, dosage form and package size
      (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
      (5) Insert only numeric values
      (6) Please provide net revenue whenever possible, otherwise provide the average price per package

21
     Company ZZZ Sample Error Report
                                          ERROR REPORT : FORM 2 BLOCK 4

     ROW#        DIN            ERROR(S)

            2           700000 DIN (700000) is not a recognized value
            3          7000001 Strength/Unit (10 MG/CAP) does not correspond to value on record (50 MG/TAB)
            6          7000002 Strength/Unit is empty
            7          7000004 Province (21) is not recognized
            8          7000004 Dosage Form (J10) is not recognized
                                Net Revenue (s) is non-numeric
            10         7000005 Dosage Form is empty
                                Province is empty
            11         7000006 Package size is empty
                                Class of Customer (2,0) is not recognized
            12                  DIN is empty
                                Class of Customer (,) is not recognized
22          13         7000006 Net Revenue and AVG Price per Package are both missing
         Sample of correctly completed Form 2,
                        Block5
     Patented Medicine                                                            FORM 2 (continued)                                                                   Privileged s.87
     Prices Review Board                                       INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                                       Patent Act


                            Reporting period:

     5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1

                                                  Corresponding Canadian Drug
                                                Identification Number (DIN) when                         Dosage                        Ex - Factory       Country or     Class of
                                                                                                     3                           3
             Generic name of medicine                                              Strength / Unit                Package Size
                                                   sold in Canada, or Assigned                           Form 3,4                                          Prov. 4      Customer 4
                                                             Number 2                                                                     Price 5
     GENERIC1                                             7000001                   50 MG/TAB               S1           10               18.8               13             3
     GENERIC1                                             7000001                   50 MG/TAB               S1           20               35.6               13             2
     GENERIC1                                             7000001                   50 MG/TAB               S1          100               12.5               15             3
     GENERIC1                                             7000001                   50 MG/TAB               S1           10               12.7               21             2
     GENERIC1                                             7000001                   50 MG/TAB               S1           10               34.0               21          4-FSS
     GENERIC2                                             7000002                    10 MG/CAP              S2          100               32.1               16             2
     GENERIC4                                             7000004                     1 MG/ML                J1         300               29.0               18             3
     GENERIC4                                             7000004                     1 MG/ML                J1         600                3.1               17             3
     GENERIC5                                             7000005                     1 MG/ML               L1          1.5                6.0               20             2
     GENERIC5                                             7000005                     1 MG/ML               L1          2.5                5.5               19             4
     GENERIC6                                             7000006                     1 MG/ML               L1           20               15.9               20             2
     GENERIC6                                             7000006                     1 MG/ML               Y1           20               56.0               16             2
     GENERIC6                                             7000006                     1 MG/ML               Y1           20                7.0               18             2
     (1) Each line of information should be fully completed to include Generic Name, DIN, Strength/Unit, Dosage Form, Package Size, Ex-Factory Price, Country or Province, Class
     of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
23   (5) In currency of the country in which the medicine is sold
      Company ZZZ filing Form 2, Block5
     Patented Medicine                                                            FORM 2 (continued)                                                                   Privileged s.87
     Prices Review Board                                       INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                                       Patent Act


                            Reporting period:

     5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1

                                                  Corresponding Canadian Drug
                                                Identification Number (DIN) when                         Dosage                        Ex - Factory       Country or     Class of
                                                                                                     3                           3
             Generic name of medicine                                              Strength / Unit                Package Size
                                                   sold in Canada, or Assigned                           Form 3,4                                          Prov. 4      Customer 4
                                                             Number 2                                                                     Price 5
     GENERIC1                                              7000001                  50 MG/TAB              S1            10               18.8               13             3
                                                           7000001                  50 MG/TAB              S1            20               35.6               13             2
     GENERIC1                                               700000                  10 MG/CAP              S1           100               12.5               15             3
     GENERIC1                                              7000001                  50 MG/TAB              S2            10               12.7               21             2
     GGENERIC1                                             7000001                  50 MG/TAB              S1            10               34.0               21          4-FSS
     GENERIC2                                              7000002                  10 MG/CAP              S2           100               32.1               16
     GENERIC4                                              7000004                                         J1           300               29.0               18             3
     GENERIC4                                              7000004                    1 MG/ML              J1           600                3.1               17
     GENERIC5                                              7000005                    1 MG/ML              L1           1.5                6.0               20             2
     GENERIC5                                              7000005                    1 MG/ML              L1           2.5                5.5               19            4,0
     GENERIC6                                                                         1 MG/ML              L1            20               15.9               25             2
     GENERIC6                                             7000006                     1 MG/ML              Y1                             56.0               16             2
     GENERIC6                                             7000006                     1 MG/ML                           20                 7.0               18             2
     (1) Each line of information should be fully completed to include Generic Name, DIN, Strength/Unit, Dosage Form, Package Size, Ex-Factory Price, Country or Province, Class
     of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) In currency of the country in which the medicine is sold
24
      Company ZZZ filing Form 2, Block5
     Patented Medicine                                                            FORM 2 (continued)                                                                   Privileged s.87
     Prices Review Board                                       INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE                                                       Patent Act


                            Reporting period:

     5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1

                                                  Corresponding Canadian Drug
                                                Identification Number (DIN) when                         Dosage                        Ex - Factory       Country or     Class of
                                                                                                     3                           3
             Generic name of medicine                                              Strength / Unit                Package Size
                                                   sold in Canada, or Assigned                           Form 3,4                                          Prov. 4      Customer 4
                                                             Number 2                                                                     Price 5
     GENERIC1                                              7000001                  50 MG/TAB              S1            10               18.8               13             3
                                                           7000001                  50 MG/TAB              S1            20               35.6               13             2
     GENERIC1                                               700000                  10 MG/CAP              S1           100               12.5               15             3
     GENERIC1                                              7000001                  50 MG/TAB              S2            10               12.7               21             2
     GGENERIC1                                             7000001                  50 MG/TAB              S1            10               34.0               21          4-FSS
     GENERIC2                                              7000002                  10 MG/CAP              S2           100               32.1               16
     GENERIC4                                              7000004                                         J1           300               29.0               18             3
     GENERIC4                                              7000004                    1 MG/ML              J1           600                3.1               17
     GENERIC5                                              7000005                    1 MG/ML              L1           1.5                6.0               20             2
     GENERIC5                                              7000005                    1 MG/ML              L1           2.5                5.5               19            4,0
     GENERIC6                                                                         1 MG/ML              L1            20               15.9               25             2
     GENERIC6                                             7000006                     1 MG/ML              Y1                             56.0               16             2
     GENERIC6                                             7000006                     1 MG/ML                           20                 7.0               18             2
     (1) Each line of information should be fully completed to include Generic Name, DIN, Strength/Unit, Dosage Form, Package Size, Ex-Factory Price, Country or Province, Class
     of Customer
     (2) For drug products with no DIN, use number assigned by the PMPRB for reporting purposes
     (3) Use a separate line for each strength/unit, dosage form and package size
     (4) See attached and/or the Patentee's Guide to Reporting for codes to be used
     (5) In currency of the country in which the medicine is sold
25
     Company ZZZ Sample Error Report
                                          ERROR REPORT FORM 2 BLOCK 5

     ROW#        DIN          ERROR(S)

            2      7000001 Generic Name is empty
            3          700000 DIN (700000) is not a recognized value
                              Strength/Unit (10 MG/CAP) does not correspond to value on record (50 MG/TAB)
            4      7000001 Dosage Form (S2) does not correspond to value on record (S1)
             5     7000002 Generic Name (GGENERIC1) does not correspond to value on record (GENERIC1)
             6     7000002 Class of Customer is empty
             7     7000004 Strength/Unit is empty
             8      700004 Class of Customer is empty
            10     7000005 Class of Customer (4,0) is not recognized
            11     7000006 DIN ( ) is empty
                           Country/Province (25) is not recognized
            12     7000006 Package Size is empty
            13     7000006 Dosage Form is empty
26
     Process for Form 2 information

      A patentee’s Form 2 information will be put through the
         PMPRB’s electronic verification system.
        If any information is missing or reported incorrectly, an error
         report is produced.
        The patentee’s Form 2 information will be returned with a
         letter indicating that it is in failure to file (FTF) The error
         report will be attached to the FTF letter.
        The error report will indicate the type of error and the line
         based on the Excel file where the error was made.
        The patentee will be given 7 days to resubmit its Form 2
27
         information.
     Other issues related to Form 2
      Block 4 - Reporting returns
      Block 5 – Reporting only prices for the same patented
       medicine
      Making amendments to Form 2
          Check box “ amendment to original filing” on Form 2
          Send revised data using Form 2 Block 4 and 5 to
           compliance@pmprb-cepmb.gc.ca
          Include a letter explaining and substantiating the changes


28
     Form 3 – Revenues and R&D Expenditures Provided
     Pursuant to Subsection 88(1) of the Patent Act and
     Sections 5 and 6 of the Patented Medicines Regulations
      Form 3 is available for the PMPRB Web site in Excel format.
      The contact for all inquiries regarding the filing of Form 3 is
       Lokanadha Cheruvu of the Policy and Economic Analysis
       Branch of the PMPRB. He can be reached at (613) 954-9812.




29
     Questions

                         Contact us

                 at pmprb@pmprb-cepmb.gc.ca

                     or at 1-877-861-2350




30

				
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language:English
pages:30
Description: The Role of the Patented Medicine Prices Review Board Over the Counter