Memorandum 2008-02: Results of serial release testing of veterinary biologics imported from the US

59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 613-773-7408
Fascimile: 613-773-7570

Date:
March 20, 2008

To:
Importers of Veterinary Biologics manufactured in the USA and licensed in Canada

The Veterinary Biologics Section (VBS) of the Canadian Food Inspection Agency (CFIA) normally releases each serial of a licensed product for sale in Canada, after CFIA-VBS reviews the manufacturer's test results for that serial, and samples of the serial pass testing by the CFIA's Biologics Evaluation Laboratory (BEL).

CFIA-VBS recognizes the veterinary biologic testing and serial release functions performed by the United States Department of Agriculture, Center for Veterinary Biologics (USDA-CVB); hence, these functions are not repeated for licensed veterinary biologics imported into Canada from the USA. Canadian annual import permits for such products carry the condition that only those serials that have been released for sale by USDA-CVB may be imported into Canada.

In order to ensure compliance with this condition, the designated Canadian importers of licensed veterinary biologics are required to obtain and keep on file a photocopy of the signed APHIS 2008 form showing CVB disposition for each imported serial. Compliance with this requirement will be verified at the time of regular importer inspections, by checking records of serials imported against the corresponding APHIS 2008 forms.

Importers of live vaccines for use in ruminants are reminded that they must also maintain in their files a copy of the results of the bluetongue virus exclusion testing for each serial imported, as described in CFIA-VBS Guideline 3.6: Guideline for Bluetongue Virus Exclusion Testing of Veterinary Biologics. Similarly, importers of live vaccines for use in porcines must have the results of pseudorabies virus exclusion testing on file for each serial imported, as described in CFIA-VBS Guideline 3.31: Guideline for Pseudorabies Virus Exclusion Testing of Veterinary Biologics.

Glen Gifford, DVM, MSc
National Manager
Veterinary Biologics Section
Animal Health Division