Memorandum 2017-02: Results of serial release testing of veterinary biologics imported from the US

59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 613-773-7786
Facsimile: 613-773-7115

Date:November 30, 2017

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

The Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency normally releases each serial of a licensed product for sale in Canada, after reviewing the manufacturer's test results for that serial.

The CCVB 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 a condition which states that only those serials that have been released for sale by the 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 the USDA-CVB disposition for each imported serial. In the case of serials which are no longer released by the USDA-CVB in paper format, the importers are required to keep a paper copy of the electronic notification issued by the USDA-CVB and of the APHIS 2008 form prepared by the manufacturer and submitted to the USDA-CVB. Compliance with this requirement will be verified by checking records of serials imported against the corresponding APHIS 2008 forms. This may be done either at the time of regular importer inspections or by requesting submission of documents during the intervening period.

Unless CCVB has waived this requirement, importers of live vaccines for use in ruminants are reminded that they must also maintain a copy of the results of the bluetongue virus exclusion testing in their files for each serial imported, as described in VB Guideline 3.6: Guideline for Bluetongue Virus Exclusion Testing of Veterinary Biologics. Similarly, unless CCVB has waived this requirement, importers of live vaccines for use in pigs must have the results of pseudorabies virus exclusion testing on file for each serial imported, as described in VB Guideline 3.31: Guideline for Pseudorabies Virus Exclusion Testing of Veterinary Biologics.

Surinder Saini, DVM, MVSc, PhD
National Manager, Canadian Centre for Veterinary Biologics
Animal Import/Export Division
Animal Health Directorate

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