Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's Access to Medicines Regime
(GUIDE-0072)

(December 1^st, 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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Attachment A - "Division 7 Notification Form"

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^st, 2007

07-117990-424

To: All Interested Parties

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Guidance for Pre-manufacturing and Pre-exportation Notifications under Canada's Access to Medicines Regime (C.07.011) (GUI-0072)", which 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

The purpose of this document is to provide guidance to manufacturers on how to comply with section C.07.011 of the Food and Drug Regulations. This document applies to manufacturers of drug products intended for export under Canada's Access to Medicines Regime. All manufacturers participating in the program must notify Health Canada as indicated in section C.07.011 of the Food and Drug Regulations and will be subject to pre-export inspections.

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

Guidance for Pre-manufacturing and Pre-exportation Notifications ( C.07.011 ) under Canada's Access to Medicines Regime

GUIDE-0072

Supersedes:
New Document

Date issued:
August 2007

Date of implementation:
September 2007

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