Draft Guidance for Industry on Management of Regulatory Submissions

Veterinary Drugs Directorate
Holland Cross Complex
Tower A, Ground Floor, Suite 14
11 Holland Avenue
Address Locator: 3000A
Ottawa, ON K1A OK9

November 25, 2003

Subject: Consultation on Health Canada's draft Guidance for Industry on Management of Regulatory Submissions

Dear Stakeholder:

Health Canada's Veterinary Drugs Directorate (VDD) is announcing the release of the Draft Guidance for Industry - Management of Regulatory Submissions document for stakeholder consultation. This guidance document has been developed to assist submission sponsors in complying with Health Canada policies and governing statutes and regulations. It is also the result of an extensive effort to re-engineer and optimize internal processes in a continuing effort to reduce the backlog and provide timely access for Canadians to safe and effective drug products.

We are seeking input on the further development of this draft policy. You can find the proposed policy at the following URL:

http://www.hc-sc.gc.ca/dhp-mps/consultation/vet/consultations/past-anterieures/vet/nds-pdn_indust_prep-eng.php

I would appreciate your collaboration in bringing this information to the attention of all interested parties in your organization so as to solicit their comments.

Written feedback should be submitted by April 1st, 2004, and directed to:

Ms. Dhurata Ikonomi
Public Involvement Officer
Strategic Planning and Stakeholder Relations, Veterinary Drugs Directorate
Health Products and Food Branch, Health Canada
Holland Cross Complex, 14 - 11 Holland Avenue
Ottawa, ON K1A 0K9
Or by fax: (613) 954-9860

We look forward to receiving your comments.

Sincerely,

Diane C. Kirkpatrick
Director General