Cover Letter - Request for comments from industry on Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products. (GUIDE-0039)

The comment period is closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The new "Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products -Guide 0039" will be made available as soon as possible.

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(January 25, 2008)

Unit Name: Drug Compliance Verification and Investigation Unit
Telephone: 613-952-9906
Fax: 613-952-9805
E-Mail: DCVIU_UVCEM@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch
Inspectorate
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator # 2003C
Ottawa, Ontario
K1A 0K9

January 25, 2008

07-123448-13

To All Interested Parties

I am pleased to inform you of a new document entitled "Health Products and Food Branch Inspectorate (HPFBI) Guidelines for Recall of Drug and Natural Health Products" (GUIDE-0039) which is now available for 60 days as a draft document for comments on the HPFBI website under the "What's New".

The current document entitled "Product Recall Procedures", containing both policy and guidance elements, will eventually be replaced by alternate documents. The policy aspect of the "Product Recall Procedures" document has already been replaced by the "Health Products and Food Branch Inspectorate - Recall Policy" (POL-0016). This guidance document will replace the Drug and Natural Health Product guidance elements of the "Product Recall Procedures".

This guidance document does not apply to medical devices, blood and blood components, cells, tissues (including semen for assisted conception) and organs. Separate Guidance documents for these are currently being developed.

Comments on the Recall Guide can be sent to the Drug Compliance Verification and Investigation Unit, Compliance and Enforcement Coordination Division, Health Products and Food Branch Inspectorate, Graham Spry Building, 3rd Floor, 250 Lanark Avenue, Address Locator # 2003A, Ottawa, Ontario, K1A 0K9, or by e-mail at DCVIU_UVCEM@hc-sc.gc.ca. within 60 days from posting.

For your convenience, please find attached a template for your comments.

Yours truly,

Original signed by

Diana Dowthwaite
Director General

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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

Guidelines for Recall of Drug and
Natural Health Products

GUIDE-0039

Supersedes:
Product Recall Procedures For Drugs and Natural Health Products

Date issued:
Draft

Date of implementation:
Draft

Ce document est aussi disponible en français.