Transcript The Role of the Patented Medicine Prices Review Board
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
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
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
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
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
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.
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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
8
Electronic Reporting
Electronic filing required for Forms 1, 2 and 3
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
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
11
Patented Medicine Prices Review Board FORM 1 MEDICINE IDENTIFICATION SHEET Use one form per DIN
Please Specify
1 NAME(S) AND USE(S) OF THE MEDICINE
Original Filing or Brand Name: Generic Name: Therapeutic use(s) of the medicine approved by Health Canada: Amendment to Original Filing
Human Prescription
OR
Human Over-the-Counter
OR
Veterinary Privileged s.87
Patent Act
Page 1 of 2 (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
) (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
)
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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.
Y M D Check if applicable
4 DRUG IDENTIFICATION NUMBER (DIN)
Drug Identification Number Dosage Form Special Access Programme or Clinical Trial Application or Investigational New Drug Strength/Unit
5 DATE OF FIRST SALE
Date of 1 st Sale Y M D
6 PRODUCT MONOGRAPH
Product Monograph
OR
(Copy Included) Information similar to that contained in a Product Monograph (Copy Included)
13
7 PATENT NUMBER OF REPORTING PATENTEE'S INVENTIONS PERTAINING TO THE MEDICINE
Patent Number Y Y Date Granted M M D D Y Y Expiration Date M M D 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: ( ) Fax Number : ( ) -
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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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Patented Medicine Prices Review Board FORM 2 INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Use one form per medicine or per DIN Privileged s.87
Patent Act
Page 1 of
Please Specify Original Filing or Amendment to Original Filing
1 REPORTING PERIOD
Period to which the information applies: Y FROM M D Y TO M D
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.
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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: ) Fax Number : ( ) -
Patented Medicine Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE 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 INDICATE EITHER 6 Packages Sold 5 Net Revenue AVG Price/Package
Privileged s.87
Patent Act
Prov. 4 Class of Customer 4 17 (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
Patented Medicine Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1
Generic name of medicine Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 Dosage Form 3,4 Package Size 3 Ex - Factory Price 5
Privileged s.87
Patent Act
Country or Prov. 4 Class of Customer 4 18 (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
19
Sample of correctly completed Form 2,
Patented Medicine Prices Review Board
Block4
FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE 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 INDICATE EITHER 6 Packages Sold 5 Net Revenue AVG Price/Package Prov. 4 7000001 50 MG/TAB 7000001 50 MG/TAB 7000001 50 MG/TAB 7000001 50 MG/TAB 7000001 50 MG/TAB 7000002 10 MG/CAP 7000004 1 MG/ML 7000004 1 MG/ML 7000005 1 MG/ML 7000005 1 MG/ML 7000006 1 MG/ML 7000006 1 MG/ML 7000006 1 MG/ML S1 S1 S1 S1 S1 S2 J1 J1 L1 L1 L1 Y1 Y1 10 20 100 10 10 100 300 600 1.5
2.5
20 20 100 849 50 14 849 849 14 4 2 176 2 18 2130 335 306665 18500 4290 306665 306665 4290 1498 8754 61780 27534 6080 756900 875237.00
351.0227
(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 1 1 6 1 1 11 12 1 2 2 3 3 13 Class of Customer 4 1 3 4 1 1 4 4 4 1 2 2 3 1
20
Company ZZZ filing Form 2, Block4
Patented Medicine Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE 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 INDICATE EITHER 6 Packages Sold 5 Net Revenue AVG Price/Package Prov. 4 7000001 50 MG/TAB 700000 50 MG/TAB 7000001 10 MG/CAP 7000001 50 MG/TAB 7000001 50 MG/TAB 7000002 S1 S1 S1 S1 S1 S2 10 20 100 10 10 100 849 50 14 849 849 14 306665 18500 4290 306665 306665 4290 7000004 1 MG/ML 7000004 1 MG/ML 7000005 1 MG/ML 7000005 1 MG/ML 7000006 1 MG/ML 1 MG/ML 7000006 1 MG/ML J1 J10 L1 L1 Y1 Y1 300 600 1.5
2.5
20 100 4 2 176 2 18 2130 335 1498 s 27534 6080 756900 (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 351.0227
21 11 12 3 3 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 1 1 6 1 1 1 Class of Customer 4 1 3 4 1 1 4 2,0 , 1 4 4 1 2
21
Company ZZZ filing Form 2, Block4
Patented Medicine Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE 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 INDICATE EITHER 6 Packages Sold 5 Net Revenue AVG Price/Package Prov. 4 Class of Customer 4 7000001 50 MG/TAB 700000 50 MG/TAB 7000001 10 MG/CAP 7000001 50 MG/TAB 7000001 50 MG/TAB 7000002 7000004 1 MG/ML 7000004 1 MG/ML 7000005 1 MG/ML 7000005 1 MG/ML 7000006 1 MG/ML 1 MG/ML 7000006 1 MG/ML S1 S1 S1 S1 S1 S2 J1 J10 L1 L1 Y1 Y1 10 20 100 10 10 100 300 600 1.5
2.5
20 100 849 50 14 849 849 14 4 2 176 2 18 2130 335 306665 18500 4290 306665 306665 4290 1498 s 27534 6080 756900 351.0227
1 1 6 1 1 1 21 11 12 3 2,0 3 , 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 4 1 1 3 1 4 4 4 1 2 1
22
Company ZZZ Sample Error Report
ROW# DIN
2 3 6 7 8 10 11 12 13
ERROR(S) ERROR REPORT : FORM 2 BLOCK 4
700000 DIN (700000) is not a recognized value 7000001 Strength/Unit (10 MG/CAP) does not correspond to value on record (50 MG/TAB) 7000002 Strength/Unit is empty 7000004 Province (21) is not recognized 7000004 Dosage Form (J10) is not recognized Net Revenue (s) is non-numeric 7000005 Dosage Form is empty Province is empty 7000006 Package size is empty Class of Customer (2,0) is not recognized DIN is empty Class of Customer (,) is not recognized 7000006 Net Revenue and AVG Price per Package are both missing
23
Sample of correctly completed Form 2,
Patented Medicine Prices Review Board
Block5
FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Privileged s.87
Patent Act
Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1
Generic name of medicine Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 Dosage Form 3,4 Package Size 3 Ex - Factory Price 5 Country or Prov. 4 Class of Customer 4 GENERIC1 GENERIC1 GENERIC1 GENERIC1 GENERIC1 GENERIC2 GENERIC4 GENERIC4 GENERIC5 7000001 7000001 7000001 7000001 7000001 7000002 7000004 7000004 7000005 50 MG/TAB 50 MG/TAB 50 MG/TAB 50 MG/TAB 50 MG/TAB 10 MG/CAP 1 MG/ML 1 MG/ML 1 MG/ML S1 S1 S1 S1 S1 S2 J1 J1 L1 10 20 100 10 10 100 300 600 1.5
18.8
35.6
12.5
12.7
34.0
32.1
29.0
3.1
6.0
13 13 15 21 21 16 18 17 20 3 2 3 2 4-FSS 2 3 3 2 GENERIC5 GENERIC6 7000005 7000006 1 MG/ML 1 MG/ML L1 L1 2.5
20 5.5
15.9
19 20 4 2 GENERIC6 GENERIC6 7000006 7000006 1 MG/ML 1 MG/ML Y1 Y1 20 20 56.0
7.0
16 18 2 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 Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Privileged s.87
Patent Act
Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1
Generic name of medicine Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 Dosage Form 3,4 Package Size 3 Ex - Factory Price 5 Country or Prov. 4 Class of Customer 4 GENERIC1 GENERIC1 GENERIC1 GGENERIC1 GENERIC2 7000001 7000001 700000 7000001 7000001 7000002 50 MG/TAB 50 MG/TAB 10 MG/CAP 50 MG/TAB 50 MG/TAB 10 MG/CAP 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 S1 S1 S1 S2 S1 S2 10 20 100 10 10 100 18.8
35.6
12.5
12.7
34.0
32.1
13 13 15 21 21 16 3 2 3 2 4-FSS GENERIC4 GENERIC4 GENERIC5 GENERIC5 GENERIC6 7000004 7000004 7000005 7000005 1 MG/ML 1 MG/ML 1 MG/ML 1 MG/ML J1 J1 L1 L1 L1 300 600 1.5
2.5
20 29.0
3.1
6.0
5.5
15.9
18 17 20 19 25 3 2 4,0 2 GENERIC6 GENERIC6 7000006 7000006 1 MG/ML 1 MG/ML Y1 20 56.0
7.0
16 18 2 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
25
Company ZZZ filing Form 2, Block5
Patented Medicine Prices Review Board FORM 2 (continued) INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Privileged s.87
Patent Act
Reporting period: 5 PUBLICLY AVAILABLE EX-FACTORY PRICES FOR CANADA AND OTHER COUNTRIES 1
Generic name of medicine Corresponding Canadian Drug Identification Number (DIN) when sold in Canada, or Assigned Number 2 Strength / Unit 3 Dosage Form 3,4 Package Size 3 Ex - Factory Price 5 Country or Prov. 4 Class of Customer 4 GENERIC1 GENERIC1 GENERIC1 GGENERIC1 GENERIC2 7000001 7000001 700000 7000001 7000001 7000002 50 MG/TAB 50 MG/TAB 10 MG/CAP 50 MG/TAB 50 MG/TAB 10 MG/CAP S1 S1 S1 S2 S1 S2 10 20 100 10 10 100 18.8
35.6
12.5
12.7
34.0
32.1
13 13 15 21 21 16 3 2 3 2 4-FSS GENERIC4 GENERIC4 GENERIC5 GENERIC5 GENERIC6 GENERIC6 GENERIC6 7000004 7000004 7000005 7000005 7000006 7000006 1 MG/ML 1 MG/ML 1 MG/ML 1 MG/ML 1 MG/ML 1 MG/ML J1 J1 L1 L1 L1 Y1 300 600 1.5
2.5
20 20 29.0
3.1
6.0
5.5
15.9
56.0
7.0
18 17 20 19 25 16 18 3 2 4,0 2 2 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 Sample Error Report
26
ROW# DIN ERROR(S) ERROR REPORT FORM 2 BLOCK 5
2 3 4 5 6 7 8 10 11 12 13 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) 7000001 Dosage Form (S2) does not correspond to value on record (S1) 7000002 Generic Name (GGENERIC1) does not correspond to value on record (GENERIC1) 7000002 Class of Customer is empty 7000004 Strength/Unit is empty 700004 Class of Customer is empty 7000005 Class of Customer (4,0) is not recognized 7000006 DIN ( ) is empty Country/Province (25) is not recognized 7000006 Package Size is empty 7000006 Dosage Form is empty
Process for Form 2 information
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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.
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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 [email protected]
Include a letter explaining and substantiating the changes
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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.
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Questions
Contact us at [email protected]
or at 1-877-861-2350