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

(December 1st, 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, 2nd Floor
250 Lanark Avenue
Address Locator # 2002B
OTTAWA, Ontario
K1A 0K9

December 1st, 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:

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

Ce document est aussi disponible en français.

Table of contents


1.0 Purpose

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.

2.0 Background

Health Canada will conduct pre-export inspections of manufacturers exporting to developing or least-developed countries under Canada's Access to Medicines Regime. Pre-export inspections, as part of anti-diversion measures, will confirm the existence of distinguishing characteristics on the products, their immediate containers, if applicable, and their labels.

Inspections will be conducted by Health Canada under the authority of sections 23 and 24 of the Food and Drugs Act. These activities will be conducted by the Health Products and Food Branch Inspectorate. Collaboration with all stakeholders taking part in Canada's Access to Medicines Regime will be essential to ensure compliance with the new regulations.

Refer to the Health Products and Food Branch Inspectorate's Inspection Strategy for Canada's Access to Medicines Regime (POL-0055) for additional information.

3.0 Scope

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.

4.0 Definitions

HPFB Inspectorate: The Health Products and Food Branch (HPFB) directorate whose primary role is to deliver a national compliance and enforcement program for all products under the mandate of the HPFB, with the exception of products regulated as foods. (Inspectorat de la DGPSA)

Inspection: On-site monitoring and assessment against the applicable requirements of the Food and Drugs Act and its associated regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance. (Inspection)

Manufacturer: "manufacturer" or "distributor" means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug (section A.01.010 of the Food and Drug Regulations). (Fabricant)

For additional definitions, consult the documents listed as references at the end of this document.

5.0 Interpretation

Section C.07.011 (Notice to Minister) of the Food and Drug Regulations states:

"The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug."

In order to comply with this regulatory requirement, the manufacturer must complete and sign the Division 7 Notification Form (see Attachment A) and send it to the Health Product and Food Branch Inspectorate no less than 15 calendar days prior to the start of manufacturing of the first lot of drug product authorized for sale under Part C Division 7 of the Food and Drug Regulations, and no less than 15 calendar days prior to the exportation of each subsequent lot of the drug product.

6.0 Attachments

7.0 Effective date

The effective date of this document is May 29, 2007.

8.0 References

  1. Food and Drugs Act
  2. Food and Drug Regulations
  3. Act to amend The Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa) - Bill C-9
  4. Regulations Amending the Food and Drug Regulations (1402 - Drugs for Developing Countries)
  5. Health Products and Food Branch Inspectorate's Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
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