Subject: Consultation on Draft Guidance for Industry: Reconsideration of Decisions Issued for Veterinary Drug Submissions

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Veterinary Drugs Directorate
Holland Cross Complex
Ground Floor, Suite 14 - 11 Holland Avenue
Address Locator: 3000A
Ottawa, ON K1A 0K9

February 22, 2007

Dear Stakeholder:

On June 19, 2003, Health Canada's Veterinary Drugs Directorate (VDD) developed a blueprint for the appeal process for veterinary drug submissions to serve industry clients more efficiently and to enhance transparency.

VDD is now proposing to replace the Blueprint with a policy that is consistent, as appropriate, with the processes developed at the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD). As a result, VDD has created a Draft Guidance for Industry: Reconsideration of Decisions Issued for Veterinary Drug Submissions (VDD Reconsideration Guidance) document and is seeking input from key partners and stakeholders on this draft.

I would appreciate your collaboration in bringing this draft policy to the attention of all interested parties in your organization so as to solicit their comments.The draft document can be accessed online.

The consultation period of 60 days will end on April 23, 2007. Written feedback should be submitted by that date and directed to:

Kathy Dobbin, Director,
Strategic Planning and Stakeholder Relations Division
Veterinary Drugs Directorate
Health Products and Food Branch, Health Canada
Holland Cross Complex, 11 Holland Avenue, Suite 14
Ottawa , ON K1A 0K9
Fax: (613) 954-9860
Email: kathy_dobbin@hc-sc.gc.ca

We look forward to receiving your comments.

Sincerely,

Siddika Mithani, Ph.D
Director General