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Veterinary Biologics Memorandum 2005-02

October 12, 2005

This is a reminder that all regulations pertinent to veterinary biologics also apply to veterinary diagnostic kits (diagnostic of infectious diseases). Hence, the failure of a veterinary diagnostic kit to perform as expected, corresponds to an adverse event and must be reported to the Veterinary Biologics Section (VBS) as specified in the Health of Animals Regulations:

Section 135.1 Every holder of a licence or permit issued under this Part shall report to the Minister, in writing, any information concerning or any evidence of, a significant deficiency in safety, potency or efficacy of a veterinary biologic within 15 days from the date on which such information or evidence is known to him or is generally known to the industry, whichever is earlier.

Since the issuance of import permits or product licence for veterinary diagnostic kits is based on the expectation of their efficacy, VBS needs to be kept informed of any evidence of failure of kit efficacy (example: controls of the kit yield values outside of the expected range stated in the instructions).

The form CFIA 2205 "Notification of Suspected Adverse Events to Veterinary Biologics" is available on line in a ready to fill format on our web site.

G.A. Gifford, DVM, MSc.
National Manager
Veterinary Biologics Section
Animal Health and Production Division