Guidance Document on the Application for Certificate of a Pharmaceutical Product (GUIDE-0024)
This page in no longer valid and a new guidance document has replaced the old one
Letter of Introduction (Guide-0024)
(July 1, 2006)
Contact Name: Head of The Establishment Licence Unit
Tel: (613) 954-6790
Fax: (613) 957-4147
E-Mail: cpp_questions@hc-sc.gc.ca
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Cover Letter
Health Products and Food Branch Inspectorate
Graham Spry Building, 2nd Floor
250 Lanark Avenue
A.L. 2002A
Ottawa, Ontario
K1A 0K9
April 18, 2006
06-105930-595
To: Stakeholders
RE: New Guidance for Certificates of a Pharmaceutical Product
We are pleased to present the new version of the Health Products and Food Branch Inspectorate's Guidance for Certificate of a Pharmaceutical Product.
The comment period, for the above noted document, ended as of December 31, 2005. Thank you, to all of you who submitted comments. All comments received were taken into consideration in the finalization of this guidance. Attached to this letter is a table summarizing the various comments received.
The new guidance document, application form and question and answer document may be found on Health Canada's Compliance and Enforcement website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php
Original signed by
Merry Bujaki
Acting Manager
Establishment Licence Unit
Comment
Analysis and Response
Please specify what changes have been made to the previous document. Provide a side-by-side comparison.
A copy of the previous version of the document will be available upon request from the Establishment Licence Unit until April 30, 2006 .
Scope: Consideration should be given to the issuance of certificates for medical devices and Natural Health Products (NHP)
Export Certificates for medical devices are issued by the Inspectorate's operational centers and International Trade Certificates are issued by the Natural Health Products Directorate for Natural Health Products (NHP)
HPFBI will continue to issue CPP until December 31, 2006 , with an expiry date of December 31, 2006 , under specific conditions.
Section 5.1 is incomplete, something should be added to allow for fabrication in a foreign country if the product has a DIN and the foreign site is GMP compliant and listed on the Canadian DEL.
Section 5.1.2 provides for the issuance of a certificate when the pharmaceutical product is fabricated in a foreign country and packaged/ labelled in Canada or fabricated in Canada and packaged/ labelled in a foreign country, if all the following requirements are met: the packager/labeller and the fabricator are GMP compliant; the foreign establishment is GMP compliant and is listed on the Canadian Drug Establishment Licence (DEL); the pharmaceutical product has a valid DIN and/or an NOC and a valid date of notification; and the pharmaceutical product is sold on the Canadian market.
Section 5.1.1 and 5.1.2 require a valid DIN and date of notification. There should be a means for a product approved in Canada but not marketed in Canada to be issued a CPP.
Section 5.1.3. provides for the issuance of a CPP when the pharmaceutical product is fabricated and/or packaged/labelled in Canada but not marketed in Canada, if the fabricator and/or packager/labeller are/is GMP compliant; and a DIN or an NOC has been issued.
Section 5.1.3 refers to pharmaceutical products with a DIN that are not marketed in Canada. What should be entered in the "Date of notification" field on the application?
"Not Notified"
Section 5.1.3 should clarify what is meant by "a DIN has been issued".
What is meant is that the drug product must have a market authorization.
Section 5.1.3 should include cases when a product is manufactured in Canada for export only and a DIN has not been issued. The bullet point "a DIN has been issued" should be replaced with, "product is manufactured for export only"
A certificate cannot be issued for products that do not have a DIN or an NOC as this would be facilitating the sale of an unapproved product which would be a contravention of the regulations.
Section 5.1.3 should include a subsection that allows a GMP compliant packager/labeller to be a foreign site listed on the Canadian Importer's DEL.
Section 5.1.3 now provides for this scenario.
Section 5.2.1 should be changed to include, "and/or the manufacturer and the packager/labeller sites are not listed on the Canadian Drug Establishment Licence," no CPP is issued.
Section 5.2.1 has been modified.
Section 5.4.3 states that a CPP is valid for one year from the date of issue. Section 5.4.4 states that if the CPP contains an error for which HPFBI is responsible, a revised CPP will be issued. The revised CPP should have a new date rather than the same date as the original.
The guidance document has been updated to include a statement that the new CPP will have a revised date of issue upon request.
Section V of the application form requests the "date of notification" whereas the CPP specifies the date of issue and the date of notification is inserted in this field. The two dates can be different. If it is preferred to provide the date of notification then this should be stated on the CPP.
The guidance document has been updated. The date of issue onto the market, that is, the date of notification, provides more relevant information that the date of issuance of the DIN. A product may have a DIN and never be marketed in Canada. The date of notification therefore provides a time frame for how long the product has actually been on the market.
Cover Page
OUR MANDATE:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.
Health Products and Food Branch Inspectorate
GUIDANCE DOCUMENT
Guidance Document on the Application for
Certificate of a Pharmaceutical Product
(Guide-0024)
Supersedes:
April 18, 2006
Date issued:
July 1, 2006
Date of implementation:
July 1, 2006
Fees previously indicated in this document have been adjusted to reflect the reduction of the Goods and Services Tax (GST) and the Harmonized Sales Tax (HST) in effect July 1, 2006
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