Guidance for Industry Preparation of Veterinary new Drug Submissions

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Veterinary Drugs Directorate
Holland Cross Complex
Tower A, Ground Floor, Suite 14
11 Holland Avenue, A.L., 3000A
Ottawa, Ontario K1A 0K9

March 19, 2007

Guidance for Industry Preparation of Veterinary new Drug Submissions

Dear Stakeholders:

In July 2006, Health Canada's Veterinary Drugs Directorate (VDD) developed a guidance document for the preparation of veterinary new drug submissions for industry which partially superseded Health Canada's 1991 Preparation of Veterinary New Drug Submission Guidelines. Since last July, we have received additional comments which have been incorporated in this revised version.

The purpose of this guidance is to assist the drug manufacturers (sponsors) with the preparation of a well-structured veterinary drug submission to facilitate its screening and subsequent review by VDD. It should be noted that all requirements in this guidance document may not necessarily apply to every product. Data requirements may vary depending on the drug and submission type for which a submission is filed.

Drug manufacturers are encourage to start using the revised guidelines as soon as it is posted on Health Canada's Web site. However, as of July 1, 2007, al submissions must conform to the format given in this Document.

As VDD staff and drug sponsors gain experience using thid document, we will continue to make anu necessary modifications.

The document can be accessed at the following URL:
Guidance for Industry Preparation of Veterinary New Drug submissions

Sincerely,

(signed)

Siddika Mithani, Ph.D
Director General