Veterinary Biologics Guideline 3.26E
Guideline for the Issuance of Veterinary Biologics Export Certificates

I. 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 to meet export certification requirements of an importing country's regulatory agency.

A. Veterinary biologics licensed for general distribution

A CFIA "Veterinary Biologics Export Certificate" or "Free Sale Certificate" will be used to confirm that a veterinary biologic 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 Production Outline (PO).

B. Veterinary biologics licensed for export only

For veterinary biologics 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.

C. Veterinary biologics manufactured in other countries and registered for use in Canada

The CCVB may also be asked to prepare a "Free Sale Certificate" or similar document for imported veterinary biologics 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 registered for general sale in Canada. The documents must also clearly indicate that the veterinary biologic 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.

II. Legal Authority

Health of Animals Regulations, Part XI

123.
No person shall prepare, manufacture, preserve, pack, label or test a veterinary biologic unless he does so under and in accordance with an establishment licence issued by the Minister.

124.
No person shall manufacture a veterinary biologic unless he does so under and in accordance with a product licence issued by the Minister.

130.
No person shall sell a veterinary biologic or any diluent to be used therewith if the veterinary biologic or diluent has been prepared, manufactured, preserved, packed, labelled or tested otherwise than in the manner described in the product outline.

III. Guidance

A. All filed production documents, testing procedures, labels, and establishment information must be kept up to date in the CCVB office.

B. For serial-specific Veterinary Biologics Export Certificate requests, samples from the serial must be submitted to a CFIA Laboratory for testing and a Manufacturer's Serial Release Test Report forwarded to CCVB for approval and release.

C. Required information from the manufacturer

1. Cover letter identifying (i) veterinary biological product including the assigned name, trade name and CCVB file number, (ii) preservatives, inactivating agents and/or antibiotics, (iii) indication for use, dose and administration, (iv) importing country, and (v) additional attestations requested by the importing country's regulatory agency and subject to review and approval by CCVB.
2. Letter or other reference document from importing country's regulatory authority specifying information to be included on the Veterinary Biologics Export Certificate.
3. Application for Services - CFIA/ACIA 4720 and applicable fees under item 11 for each certificate.

D. Additional requirements - serial-specific requests

1. Serial number(s) of the veterinary biological product.
2. Number of doses to be shipped.
3. Container size and volume/weight.
4. Distributor information.
5. Other information requested by the importing country's regulatory agency and subject to review and approval by CCVB.

E. Additional requirements - for export only products

1. Product and/or serial expiry information.
2. Statement regarding the regulatory status of veterinary biologic in importing country (eg. fully licensed, under investigation use, under special marketing authorization).

F. Documents from the importing country's regulatory agency in languages other than English or French must be accompanied by certified translations.

G. Requests for Veterinary Biologics Export Certificates should be mailed to the CCVB office. Please allow up to two weeks for processing.

H. Completed Veterinary Biologics Export Certificates carrying the official CFIA stamp will be sent back to the manufacturer by regular postal service unless otherwise instructed by the applicant. Requests for courier shipments must be pre-paid.

IV. Related Guidelines and References

Refer to the Canadian Centre for Veterinary Biologics website.

V. For further information

Any further questions or clarifications regarding the regulations and requirements pertaining to the issuance of CFIA Veterinary Biologics Export Certificates may be directed to the Canadian Centre for Veterinary Biologics.