Consultations - Veterinary Drugs Directorate's (VDD's) Animal Tissue Form

Dear Stakeholders:

Subject: Consultation on Health Canada's Veterinary Drugs Directorate's (VDD's) Animal Tissue Form

Recent public health concerns such as Bovine Spongiform Encephalopathy (BSE) have highlighted the need for Health Canada to have access to the most up-to-date information concerning animal-sourced materials in drugs that are administered to animals. Addressing these needs is part of a proactive approach to emerging animal diseases and unanticipated changes in the nature of existing animal diseases.

In the case of BSE, the specified risk material (SRM) prohibition to food does not specifically address the use of bovine-derived material in health products such as veterinary drugs. In order to identify potential risks, information concerning animal-sourced materials in drugs administered to animals is required.

Health Canada's Veterinary Drugs Directorate (VDD) is seeking your comments on the development of an Animal Tissue Form. This form, which is specific to VDD, requests information on animal-sourced material used in the manufacture veterinary drugs. Data collected on product formulation will enable VDD to develop appropriate strategies to minimize possible health risks and help safeguard Canada's food supply.

The Animal Tissue Form is intended for all manufacturers and sponsors of veterinary drugs submitted for approval as either:

New Drug Submissions (NDS)
Abbreviated new drug submissions (ABNDS)
Supplemental new drug submissions (SNDS)
Supplemental abbreviated new drug submissions (SABNDS)
Notifiable change (NC)
DIN applications (DIN)
Investigational New Drug submissions (IND)

Once finalized, the form will become an integral component of veterinary drug submissions.

You can access the electronic version of the draft form on our Web site at: http://www.hc-sc.gc.ca/dhp-mps/consultation/vet/consultations/tissu-animal/animal_tis_form-eng.php

Your collaboration in bringing this information to the attention of all interested parties in your organization would be appreciated.

Written feedback should be submitted by January 31, 2005, and directed to:

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.

Yours sincerely,

Diane C. Kirkpatrick
Director General