Inspection Strategy for Post-Market Surveillance (POL-0041)

(June 25, 2004)

Contact Name: Drug GMP Inspection Unit
Fax: (613) 952-9805
E-Mail: pmrc-cedac@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Holland Cross, Tower "A", 2nd Floor
11 Holland Avenue
Address Locator # 3002C
OTTAWA, Ontario
K1A 0K9

June 25, 2004

04-111580-166

To: Associations and Stakeholders

I am pleased to inform you that Health Canada is implementing an inspection programme for post-market surveillance for drugs. The Health Products and Food Branch Inspectorate, in collaboration with the Marketed Health Products Directorate, will verify compliance of manufacturers (as defined in the Food and Drug Regulations section A.01.010) with the regulatory requirements pertaining to the reporting of adverse drug reactions and reporting of unusual failure in efficacy of new drugs to Health Canada.

An Inspection Strategy detailing the plan for the effective and uniform implementation of a national inspection programme can be found on the Inspectorate website at:

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate

Inquiries about the post-market surveillance drug inspection programme can be sent to the Inspectorate via fax at (613) 952-9805 or e-mail at postmarketsurveillance@hc-sc.gc.ca.

Original signed by
Diana Dowthwaite (for)

Jean Lambert
Director General

Cover Page

Health Products and Food Branch Inspectorate

Policy Document Inspection Strategy for Post-Market Surveillance

Supersedes:
New document

Date issued:
June 2004

Date of implementation:
August 1^st, 2004

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