Inspection Strategy for Canada's Access to Medicines Regime (POLICY-0055)

(December 1, 2007)

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

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Cover Letter

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

December 1, 2007

07-117987-250

To: ALL INTERESTED PARTIES

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)", which is now available on Health Canada's Compliance and Enforcement website at:

http://hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

The purpose of this document is to detail the Health Product and Food Branch Inspectorate's strategy for the effective and uniform implementation of Canada's Access to Medicines Regime (CAMR) inspection program to assess compliance with the regulatory requirements as detailed in the Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), formerly Bill C-9, and in the Regulations Amending the Food and Drug Regulations (1402 - Drugs for Developing Countries). This inspection strategy applies to manufacturers of drug products intended for exportation under Canada's Access to Medicines Regime.

A draft version of the document was posted on the Health Canada website for a 60 day comment period in June 2006. Comments received from stakeholders and interested parties were reviewed and those that were accepted have been incorporated in this new version.

Inquiries about this guidance document can be submitted in writing by mail to the Manager, Drug GMP Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. #2002B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613-957-6709, or by e-mail at GMP_questions_BPF@hc-sc.gc.ca.

Original signed by

Diana Dowthwaite
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

Inspection Strategy for Canada's
Access to Medicines Regime

POLICY-0055

Supersedes:
New document

Date issued:
August 2007

Date of implementation:
September 2007

Ce document est aussi disponible en français.