Risk Classification of Post-Market Reporting Compliance Observations (GUI-0063)

(October 21, 2005)

Contact Name: Drug GMP Inspection Unit
Telephone: 613-957-1492
Fax: 613-957-6709
Email: pmrc-cedac@hc-sc.gc.ca

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Please note that the e-mail address stated in the letter has been changed to
pmrc-cedac@hc-sc.gc.ca.

Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 2nd Floor
250 Lanark Avenue
Address Locator # 2002B
OTTAWA, Ontario
K1A 0K9

October 21, 2005

05-122763-656

To: Associations / Stakeholders

Health Canada has implemented an inspection programme for Post-Market Reporting Compliance 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.

I am pleased to inform you that the final version of the guidance document entitled "Risk Classification of Post-Market Reporting Compliance Observations" is now available on Health Canada's Compliance and Enforcement website at: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

Questions on the guidance document can be sent to the Inspectorate via fax at (613) 957-6709 or e-mail at postmarketsurveillance@hc-sc.gc.ca.

Original signed by
Kim Dix (for)

Jean Lambert
Director General

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

Guide-0063

Risk Classification of Post-Market Reporting Compliance Observations

Supersedes:
June 2004

Date issued:
October 21, 2005

Date of implementation:
November 21, 2005

Ce document est aussi disponible en français.

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