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
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