patented medicines regulations review of reporting changes

Patented Medicines Regulations Review of Reporting Changes

Ginette Tognet, Béatrice Mullington & Marc LegaultCompliance and Enforcement Branch

Montréal, Québec Toronto, OntarioMay 27, 2008 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.

7


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

mailto:[email protected]

8


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 Privileged s.87

Prices Review Board 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:

Human Prescription

OR

Human Over-the-Counter

OR

Veterinary

MEDICINE IDENTIFICATION SHEETFORM 1

(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 )

12

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

Date of 1st Sale OR

Y M D

(Copy Included)(Copy Included)

Product Monograph Information similar to that contained in a Product Monograph

13

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

Patent Number

Date Granted Expiration Date

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: ( ) - Fax Number : ( ) -

E-mail:

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.

15


Prices Review Board INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patent Act

Use one form per medicine or per DIN1 of

Please Specify Original Filing or Amendment to Original Filing

1 REPORTING PERIOD

Y M D Y 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 entitledto the benefits of a patent or to exercise any rights in relation to a patent. This includes patent holders, licensees or others.

Period to which the information applies:

FORM 2

Page

FROM TO

16

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:

17



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 Dosage Package INDICATE EITHER 6

Class of

Assigned Number 2 Form 3,4 Size 3, 5Net Revenue AVG Price/Package 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

Prov. 4Number of

Packages Sold 5

FORM 2 (continued)INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE

18



Reporting period:

Ex - Factory

Price 5

(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

(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


Class of

Customer 4Strength / Unit 3

Dosage

Form 3,4

Country or

Prov. 4Package Size 3Generic name of medicine

Corresponding Canadian Drug Identification Number (DIN) when

sold in Canada, or Assigned

Number 2

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

19

Sample of correctly completed Form 2, Block4



Reporting period:



Class of


7000001 50 MG/TAB S1 10 849 306665 1 17000001 50 MG/TAB S1 20 50 18500 1 37000001 50 MG/TAB S1 100 14 4290 6 47000001 50 MG/TAB S1 10 849 306665 1 17000001 50 MG/TAB S1 10 849 306665 1 17000002 10 MG/CAP S2 100 14 4290 1 47000004 1 MG/ML J1 300 4 1498 2 47000004 1 MG/ML J1 600 2 8754 11 47000005 1 MG/ML L1 1.5 176 61780 351.0227 12 17000005 1 MG/ML L1 2.5 2 27534 2 27000006 1 MG/ML L1 20 18 6080 3 27000006 1 MG/ML Y1 20 2130 756900 3 37000006 1 MG/ML Y1 100 335 875237.00 13 1

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) Each line of information should be completed to include DIN or Assigned Number, Strength/Unit, Dosage Form, Package Sise, Number of Packages

Prov. 4Number of

Packages Sold 5


20

Company ZZZ filing Form 2, Block4Patented Medicine Privileged s.87


Reporting period:



Class of


7000001 50 MG/TAB S1 10 849 306665 1 1700000 50 MG/TAB S1 20 50 18500 1 3

7000001 10 MG/CAP S1 100 14 4290 6 47000001 50 MG/TAB S1 10 849 306665 1 17000001 50 MG/TAB S1 10 849 306665 1 17000002 S2 100 14 4290 1 47000004 1 MG/ML J1 300 4 1498 21 47000004 1 MG/ML J10 600 2 s 11 47000005 1 MG/ML L1 1.5 176 351.0227 12 17000005 1 MG/ML 2.5 2 27534 27000006 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



Prov. 4Number of

Packages Sold 5


21



Reporting period:


Drug Identification Number (DIN) or Strength/Unit 3 Dosage Package INDICATE EITHER 6 Class of


7000001 50 MG/TAB S1 10 849 306665 1 1700000 50 MG/TAB S1 20 50 18500 1 3

7000001 10 MG/CAP S1 100 14 4290 6 47000001 50 MG/TAB S1 10 849 306665 1 17000001 50 MG/TAB S1 10 849 306665 1 17000002 S2 100 14 4290 1 47000004 1 MG/ML J1 300 4 1498 21 47000004 1 MG/ML J10 600 2 s 11 47000005 1 MG/ML L1 1.5 176 351.0227 12 17000005 1 MG/ML 2.5 2 27534 27000006 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



Prov. 4Number of

Packages Sold 5


22

Company ZZZ Sample Error Report

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

13 7000006 Net Revenue and AVG Price per Package are both missing

ERROR REPORT : FORM 2 BLOCK 4

23

Sample of correctly completed Form 2, Block5



Reporting period:

Ex - Factory

Price 5

GENERIC1 10 18.8GENERIC1 20 35.6GENERIC1 100 12.5GENERIC1 10 12.7GENERIC1 10 34.0GENERIC2 100 32.1GENERIC4 300 29.0GENERIC4 600 3.1GENERIC5 1.5 6.0GENERIC5 2.5 5.5GENERIC6 20 15.9GENERIC6 20 56.0GENERIC6 20 7.0



J1L1L1L1

Y11 MG/ML

1 MG/ML1 MG/ML1 MG/ML

50 MG/TAB

S1S2

1 MG/ML J1

50 MG/TAB50 MG/TAB10 MG/CAP

7000004700000470000057000005

2116

70000017000001700000170000017000002

S1S1

S132

2

4-FSS23324

2

7000001


2

Class of

Customer 4

13131521

32

50 MG/TAB

Strength / Unit 3 Dosage

Form 3,4

Country or

Prov. 4Package Size 3

S150 MG/TAB

Generic name of medicine



Number 2


1817201920

187000006 1 MG/ML Y1 16

1 MG/ML7000006

7000006

24



Reporting period:

Ex - Factory

Price 5

GENERIC1 10 18.820 35.6

GENERIC1 100 12.5GENERIC1 10 12.7GGENERIC1 10 34.0GENERIC2 100 32.1GENERIC4 300 29.0GENERIC4 600 3.1GENERIC5 1.5 6.0GENERIC5 2.5 5.5GENERIC6 20 15.9GENERIC6 56.0GENERIC6 20 7.0



J1L1L1L1

1 MG/ML


10 MG/CAP

S1S2J1


7000004700000470000057000005

2116

7000001700000

700000170000017000002

S1S2

S132

2

4-FSS

3

24,0

2

7000001


2

Class of

Customer 4

13131521

32

50 MG/TAB

Strength / Unit 3Dosage

Form 3,4

Country or


S150 MG/TAB




Number 2


1817201925

187000006 1 MG/ML Y1 16

1 MG/ML

7000006

25



Reporting period:

Ex - Factory

Price 5

GENERIC1 10 18.820 35.6

GENERIC1 100 12.5GENERIC1 10 12.7GGENERIC1 10 34.0GENERIC2 100 32.1GENERIC4 300 29.0GENERIC4 600 3.1GENERIC5 1.5 6.0GENERIC5 2.5 5.5GENERIC6 20 15.9GENERIC6 56.0GENERIC6 20 7.0


25

187000006 1 MG/ML Y1 16

1 MG/ML

7000006

18172019




Number 2


32

50 MG/TAB

Strength / Unit 3Dosage

Form 3,4

Country or


S150 MG/TAB

7000001


2

Class of

Customer 4

13131521

32

2

4-FSS

3

24,0

2

2116

7000001700000

700000170000017000002

S1S2

S1

7000004700000470000057000005

10 MG/CAP

S1S2J1



J1L1L1L1

1 MG/ML


26

Company ZZZ Sample Error Report

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 empty7 7000004 Strength/Unit is empty8 700004 Class of Customer is empty

10 7000005 Class of Customer (4,0) is not recognized11 7000006 DIN ( ) is empty

Country/Province (25) is not recognized12 7000006 Package Size is empty13 7000006 Dosage Form is empty

ERROR REPORT FORM 2 BLOCK 5

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

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


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

Questions

Contact us

at [email protected]

or at 1-877-861-2350


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