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Patented Medicines Regulations Review of Reporting Changes Ginette Tognet, Béatrice Mullington & Marc Legault Compliance and Enforcement Branch Montréal, Québec May 27, 2008 Toronto, Ontario June 3, 2008 Objectives Overview of amendments to the Patented Medicines 2 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 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 4 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 overthe-counter drug products All data to be submitted to PMPRB required to be done in electronic format Recognition of electronic signatures 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: [email protected] 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 10 Indicate whether drug product is Human prescription, Human over-thecounter or Veterinary Date of first sale Product monograph if NOC is granted; if NOC not granted, information similar to product monograph FORM 1 MEDICINE IDENTIFICATION SHEET Patented Medicine Prices Review Board Use one form per DIN Please Specify Original Filing or Privileged s.87 Patent Act Page 1 of 2 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: Human Prescription (The medicine is for human use and contains a controlled substance as defined in the Controlled 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 Human Over-the-Counter OR Veterinary 11 (The medicine is for human use and does not contain a controlled substance as defined in the 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 ) 2 REPORTING PATENTEE Patentee Name Patentee Address Identity if the reporting the patent holder patentee is: 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. Y M D Check if Special Access Programme applicable or Clinical Trial Application or Investigational New Drug 4 DRUG IDENTIFICATION NUMBER (DIN) Drug Identification Number Dosage Form 5 DATE OF FIRST SALE 6 PRODUCT MONOGRAPH Product Monograph Date of 1st Sale Y M Strength/Unit D (Copy Included) OR Information similar to that contained in a Product Monograph (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 8 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: E-mail: 13 ( ) - Fax Number : ( ) - 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 Prices Review Board FORM 2 INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Privileged s.87 Patent Act Use one form per medicine or per DIN Page Please Specify Original Filing or 1 of Amendment to Original Filing 1 REPORTING PERIOD Period to which the information applies: FROM Y TO M D Y M 2 NAMES OF THE MEDICINE Brand name of the medicine Generic name of the medicine 3 REPORTING PATENTEE* Patentee Name Patentee Address *Please see section 79(1) of the Patent Act for the definition of a "patentee". Note that a patentee is any person entitled to the benefits of a patent or to exercise any rights in relation to a patent. This includes patent holders, licensees or others. 15 D 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: E-mail: 16 ( ) - Fax Number : ( ) - FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 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 Assigned Number 2 Strength/Unit 3 Dosage Form 3,4 Package Size 3, 5 Number of Packages Sold 5 INDICATE EITHER Net Revenue 6 Prov. 4 AVG Price/Package Class of Customer 4 (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 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 Patent Act Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES Generic name of medicine Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 1 Dosage Form 3,4 Ex - Factory Package Size 3 Price 5 Country or Prov. 4 Class of Customer (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 4 Sample of correctly completed Form 2, Block4 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 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 Assigned Number 2 Strength/Unit 3 Dosage Form 3,4 Package Size 3, 5 Number of Packages Sold 5 INDICATE EITHER Net Revenue 6 Prov. 4 AVG Price/Package 7000001 50 MG/TAB S1 10 849 306665 1 7000001 50 MG/TAB S1 20 50 18500 1 7000001 50 MG/TAB S1 100 14 4290 6 7000001 50 MG/TAB S1 10 849 306665 1 7000001 50 MG/TAB S1 10 849 306665 1 7000002 10 MG/CAP S2 100 14 4290 1 7000004 1 MG/ML J1 300 4 1498 2 7000004 1 MG/ML J1 600 2 8754 11 7000005 1 MG/ML L1 1.5 176 61780 351.0227 12 7000005 1 MG/ML L1 2.5 2 27534 2 7000006 1 MG/ML L1 20 18 6080 3 7000006 1 MG/ML Y1 20 2130 756900 3 7000006 1 MG/ML Y1 100 335 875237.00 13 (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 Class of Customer 4 1 3 4 1 1 4 4 4 1 2 2 3 1 Company ZZZ filing Form 2, Block4 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 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 Assigned Number Strength/Unit 3 2 7000001 700000 7000001 7000001 7000001 7000002 7000004 7000004 7000005 7000005 7000006 50 MG/TAB 50 MG/TAB 10 MG/CAP 50 MG/TAB 50 MG/TAB Dosage Form 3,4 S1 S1 S1 S1 S1 S2 J1 J10 L1 Package Size 3, 5 10 20 100 10 10 100 300 600 1.5 2.5 Number of Packages Sold 5 INDICATE EITHER Net Revenue 6 Prov. 4 AVG Price/Package 849 306665 1 50 18500 1 14 4290 6 849 306665 1 849 306665 1 14 4290 1 1 MG/ML 4 1498 21 1 MG/ML 2 s 11 1 MG/ML 176 351.0227 12 1 MG/ML 2 27534 1 MG/ML L1 18 6080 3 1 MG/ML Y1 20 2130 756900 3 7000006 1 MG/ML Y1 100 335 13 (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 Class of Customer 4 1 3 4 1 1 4 4 4 1 2 2,0 , 1 Company ZZZ filing Form 2, Block4 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 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 Assigned Number 2 Strength/Unit 3 Dosage Form 3,4 Package Size 3, 5 Number of Packages Sold 5 INDICATE EITHER Net Revenue 6 Prov. 4 AVG Price/Package Class of Customer 4 7000001 50 MG/TAB S1 10 849 306665 1 700000 50 MG/TAB S1 20 50 18500 1 7000001 10 MG/CAP S1 100 14 4290 6 7000001 50 MG/TAB S1 10 849 306665 1 7000001 50 MG/TAB S1 10 849 306665 1 7000002 S2 100 14 4290 1 7000004 1 MG/ML J1 300 4 1498 21 7000004 1 MG/ML J10 600 2 s 11 7000005 1 MG/ML L1 1.5 176 351.0227 12 7000005 1 MG/ML 2.5 2 27534 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) 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 1 3 4 1 1 4 4 4 1 2 1 Company ZZZ Sample Error Report ERROR REPORT : FORM 2 BLOCK 4 ROW# DIN 2 ERROR(S) 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 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 Patent Act Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1 Generic name of medicine 23 Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 Dosage Package Size Form 3,4 Ex - Factory 3 Price 5 Country or Prov. 4 Class of Customer 4 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 (5) In currency of the country in which the medicine is sold Company ZZZ filing Form 2, Block5 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 Patent Act Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1 Generic name of medicine GENERIC1 Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 7000001 7000001 700000 7000001 7000001 7000002 7000004 7000004 7000005 7000005 Strength / Unit 50 MG/TAB 50 MG/TAB 10 MG/CAP 50 MG/TAB 50 MG/TAB 10 MG/CAP 3 Dosage Package Size Form 3,4 S1 S1 S1 S2 S1 S2 J1 J1 L1 L1 L1 Y1 10 20 100 10 10 100 300 600 1.5 2.5 20 Ex - Factory 3 Price 5 Country or Prov. 4 Class of Customer 4 18.8 13 3 35.6 13 2 GENERIC1 12.5 15 3 GENERIC1 12.7 21 2 GGENERIC1 34.0 21 4-FSS GENERIC2 32.1 16 GENERIC4 29.0 18 3 GENERIC4 1 MG/ML 3.1 17 GENERIC5 1 MG/ML 6.0 20 2 GENERIC5 1 MG/ML 5.5 19 4,0 GENERIC6 1 MG/ML 15.9 25 2 GENERIC6 7000006 1 MG/ML 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 FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patented Medicine Prices Review Board Privileged s.87 Patent Act Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1 Generic name of medicine GENERIC1 Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 50 MG/TAB 50 MG/TAB 10 MG/CAP 50 MG/TAB 50 MG/TAB 10 MG/CAP 3 Dosage Package Size Form 3,4 S1 S1 S1 S2 S1 S2 J1 J1 L1 L1 L1 Y1 10 20 100 10 10 100 300 600 1.5 2.5 20 Ex - Factory 3 Price 5 Country or Prov. 4 Class of Customer 4 18.8 13 3 35.6 13 2 GENERIC1 12.5 15 3 GENERIC1 12.7 21 2 GGENERIC1 34.0 21 4-FSS GENERIC2 32.1 16 GENERIC4 29.0 18 3 GENERIC4 1 MG/ML 3.1 17 GENERIC5 1 MG/ML 6.0 20 2 GENERIC5 1 MG/ML 5.5 19 4,0 GENERIC6 1 MG/ML 15.9 25 2 GENERIC6 7000006 1 MG/ML 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 7000001 7000001 700000 7000001 7000001 7000002 7000004 7000004 7000005 7000005 Strength / Unit Company ZZZ Sample Error Report ERROR REPORT FORM 2 BLOCK 5 ROW# DIN 2 3 ERROR(S) 7000001 Generic Name is empty 700000 DIN (700000) is not a recognized value Strength/Unit (10 MG/CAP) does not correspond to value on record (50 MG/TAB) 4 5 6 7 8 10 11 26 12 13 7000001 Dosage Form (S2) does not correspond to value on record (S1) 7000002 7000002 7000004 700004 7000005 7000006 Generic Name (GGENERIC1) does not correspond to value on record (GENERIC1) Class of Customer is empty Strength/Unit is empty Class of Customer is empty Class of Customer (4,0) is not recognized DIN ( ) is empty Country/Province (25) is not recognized 7000006 Package Size is empty 7000006 Dosage Form is empty Process for Form 2 information A patentee’s Form 2 information will be put through the 27 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. 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 28 Check box “ amendment to original filing” on Form 2 Send revised data using Form 2 Block 4 and 5 to [email protected] Include a letter explaining and substantiating the changes 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 [email protected] or at 1-877-861-2350 30