Patented Medicines Regulations Review of Reporting Changes

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Patented Medicines Regulations Review of
Reporting Changes

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• Ginette Tognet, Béatrice Mullington Marc
  Legault
• Compliance and Enforcement Branch
• Montréal, Québec Toronto, Ontario
• May 27, 2008 June 3, 2008

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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

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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

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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

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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

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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 Boards 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.

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Electronic Reporting

• Electronic filing required for Forms 1, 2 and 3
• Completed forms must be sent to
  compliance_at_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

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Electronic Reporting

• Electronic filing required for Forms 1, 2 and 3

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FORM 1 and FORM 2

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

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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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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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Sample of correctly completed Form 2, Block4
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Company ZZZ filing Form 2, Block4
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Company ZZZ filing Form 2, Block4
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Company ZZZ Sample Error Report
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Sample of correctly completed Form 2, Block5
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Company ZZZ filing Form 2, Block5
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Company ZZZ filing Form 2, Block5
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Company ZZZ Sample Error Report
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Process for Form 2 information

• A patentees Form 2 information will be put
  through the PMPRBs electronic verification
  system.
• If any information is missing or reported
  incorrectly, an error report is produced.
• The patentees 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.

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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_at_pmprb-cepmb.gc.ca
• Include a letter explaining and substantiating
  the changes

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Form 3 Revenues and RD 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 [phone].

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Questions

• Contact us
• at pmprb_at_pmprb-cepmb.gc.ca
• or at 1-877-861-2350