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VB-GL-3.26: Issuance of veterinary biologics export certificates

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1. Introduction

Upon request from Canadian manufacturers, the Canadian Centre for Veterinary Biologics (CCVB) can issue a Veterinary Biologics Export Certificate or equivalent document confirming the regulatory status of a specific veterinary biologic (VB) to meet export certification requirements of an importing country's regulatory agency.

Veterinary biologics licensed for general distribution

A CFIA "Veterinary Biologics Export Certificate" or "Free Sale Certificate" will be used to confirm that a VB is licensed in Canada and meets the requirements of the Health of Animals Act and regulations. The Veterinary Biologics Export Certificate will also specify that the product is manufactured in a licensed Canadian establishment and that each serial is released as per criteria specified in an approved Outline of Production (OP; production outline, PO).

Veterinary biologics licensed for export only

For VB licensed in Canada as "For export only" (FEO) the Veterinary Biologics Export Certificate will specify that the product is manufactured in a licensed Canadian establishment, is licensed for export only and is not for sale in Canada.

Veterinary biologics manufactured in other countries and licensed for use in Canada

The CCVB may also be asked to prepare a "Free Sale Certificate" or similar document for imported VB products which have not been manufactured in Canada but are approved for distribution and sale in Canada, as well as export to other countries. Documents prepared for these products may only include a statement confirming that a product is licensed for general sale in Canada. The documents must also clearly indicate that the VB is manufactured in (specify country) and imported for distribution and use in Canada.

Additional statements and information may be added to the Veterinary Biologics Export Certificate on a case by case basis, and subject to review and approval by CCVB.

1.1. Legal authority

2. Guidance

3. For further information

Any further questions or clarification regarding the regulations and requirements pertaining to the issuance of CFIA Veterinary Biologics Export Certificates may be directed to the CCVB.

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