1. Patented Medicines Regulations Review of Reporting Changes Ginette Tognet, Béatrice Mullington & Marc Legault Compliance and Enforcement Branch Montréal, QuébecToronto, Ontario May 27, 2008June 3, 2008 This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep track of these action items during your presentation In Slide Show, click on the right mouse button Select “Meeting Minder” Select the “Action Items” tab Type in action items as they come up Click OK to dismiss this box This will automatically create an Action Item slide at the end of your presentation with your points entered.

2. 2 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

3. 3 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”

4. 4 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

5. 5 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

6. 6 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.

7. 7 Electronic Reporting  Electronic filing required for Forms 1, 2 and 3  Completed forms must be sent to: compliance@pmprb-cepmb.gc.cacompliance@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

8. 8 Electronic Reporting  Electronic filing required for Forms 1, 2 and 3

9. 9 FORM 1 and FORM 2  The next part of the presentation will be a step by step review of Form 1 and Form 2.

10. 10 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

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14. 14 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.

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19. 19 Sample of correctly completed Form 2, Block4

20. 20 Company ZZZ filing Form 2, Block4

21. 21 Company ZZZ filing Form 2, Block4

22. 22 Company ZZZ Sample Error Report

23. 23 Sample of correctly completed Form 2, Block5

24. 24 Company ZZZ filing Form 2, Block5

25. 25 Company ZZZ filing Form 2, Block5

26. 26 Company ZZZ Sample Error Report

27. 27 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 information.

28. 28 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 compliance@pmprb-cepmb.gc.ca  Include a letter explaining and substantiating the changes

29. 29 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.

30. 30 Questions Contact us at pmprb@pmprb-cepmb.gc.capmprb@pmprb-cepmb.gc.ca or at 1-877-861-2350