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Veterinary Biologics Guideline 3.21E
Guideline for the importation of veterinary biologics for research or emergency use
I. Introduction
The Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics in Canada and for regulating their importation and use.
Under certain special circumstances, Canadian veterinarians can apply for permission to import a veterinary biologic (also referred to as "product" in this document) which is unlicensed in Canada, for use under their supervision in research or in emergency situations. For some products, this provision is restricted to specific serials. The import and use of unlicensed product must be properly justified by the importing veterinarian. Applications to import unlicensed products will be reviewed on a case-by-case basis. Imported, unlicensed product must be shipped directly from the manufacturer and not from third parties.
II. Legal Authority
Health of Animals Regulations
Section 121.(1)
No person shall import a veterinary biologic into Canada unless he does so under and in accordance with a permit issued by the Minister.
Section 122.(1)(h)
Subject to subsection (2), every applicant for a permit to import a veterinary biologic into Canada shall include with his application
any information the Minister may require in order to determine, in the course of assessing the safety of the veterinary biologic, whether the introduction of the veterinary biologic into the environment could result in the spread within Canada of a vector, disease or toxic substance that would have a harmful effect on human or animal health.
Section 131.1(1)
Where an emergency exists with respect to the availability of and need for a veterinary biologic, the Minister may exempt that veterinary biologic from the application of any of the provisions of these Regulations during the period of the emergency.
III. Guidance
A. An application for a permit to import veterinary biologics must include the following documents. Note that all forms are available from our website. Items 1-3 must be signed and submitted by the importing veterinarian.
1. Covering letter from the importing veterinarian
The application must include a letter from the importing veterinarian to briefly explain the rationale for importing and using unlicensed product in Canada. Details listed below must be provided.
a) The name and address of the farms or clinics where the product will be used.
b) The reason for deciding to use the proposed product. In the case of vaccines or antibody products to be used on farm, include the incidence of disease on those farms; test results of the affected animals on those farms; information on other vaccines or antibody products used; the success or failure rate. In the case of in vitro diagnostic test kits, please include information on other kits used.
c) Confirm that the product will be used under the supervision of the importing veterinarian.
d) Confirm that the importing veterinarian and clients are aware that the product is not licensed and has not been evaluated as a veterinary biologic in Canada, and is being imported for investigational or emergency use.
e) The number of doses or vials, diagnostic tests or kits to be imported.
f) If French is not used on the product label, importing veterinarians in Quebec must confirm their willingness to use such product.
2. Application for Services - CFIA/ACIA 4720
This form must be submitted with applicable cost recovery fee ($60), under Item 4(a) for research use or item 4(b) for emergency use, as specified in the Summary of Fees and Services Related to Veterinary Biologics - CFIA/ACIA 5189.
3. Application for Permit to Import Veterinary Biologics Into Canada - CFIA/ACIA 1493.
B. Items 4-10 below must be submitted by the manufacturer directly to CCVB. This should be done when requested by CCVB, as some documents may be on file, supporting previous import permit requests.
4. USDA Veterinary Biologics Establishment License or other country's equivalent document
Product imported from the USA must be produced in a facility licensed by the Center for Veterinary Biologics (CVB), United States Department of Agriculture (USDA). Product imported from other countries must be licensed for use in that country and produced in a facility licensed by the pertinent regulatory authority in that country.
5. USDA Veterinary Biological Product License or other country's equivalent document
Product imported from the USA for emergency use must be licensed for use in the United States by the CVB. Product imported from other countries must be licensed by the pertinent regulatory authority for use in that country or region. Research requests for use of unlicensed product will be considered on a case by case basis.
6. Manufacturer's Production Outline or equivalent document
This official document describes the materials and procedures which are used for preparing and testing the product. It contains confidential business information, and is ordinarily submitted by the manufacturer directly to CCVB.
7. Summary of test results or equivalent document
The manufacturer must submit directly to CCVB, a copy of the summary test results for the serial(s) to be imported into Canada. For product imported from the USA, submit a copy of the summary of test results (APHIS Form 2008). This document verifies that the serial has been tested, found satisfactory and released for sale by USDA-CVB. For product imported from other countries, submit an official summary of test results, batch release certificate or equivalent document signed by the "Qualified Person".
8. Product labels
One copy of the labels that will be used for the product to be imported into Canada may be requested. In some cases, CCVB may have specific requirements such as use of the statement, "For experimental use only" or "Not for sale in Canada".
The language used on the label must be one or both official languages of Canada. In Quebec, provincial law requires French labelling. If French is not used on the product label, importing veterinarians in Quebec must confirm their willingness to use such product.
9. Information on the material of animal origin
Please list all material of animal origin used in the preparation of the veterinary biologic, including the ingredients of the media on which master seeds were grown. For each ingredient state the animal species and tissue/organ from which it was derived, the country of origin of the animal and the name and address of the supplier. e.g. Trypsin - porcine - pancreas - Poland - ABC Inc., USA.
10. Declaration of Compliance signed by the manufacturer
See: Veterinary Biologics Guideline 3.32E (Appendix I)
Note that CCVB may request additional documents such as experimental protocols, facility inspection or certification reports, environmental assessments, summary of suspect adverse reaction reports/vaccino-vigilance data, from the importing veterinarian or manufacturer, as appropriate.
IV. Related Guidelines and References
Please consult the web site of Canadian Centre for Veterinary Biologics for all Guidelines and Forms.
V. For further information
Any further questions from manufacturers and importing veterinarians or requests for clarification regarding the regulations and requirements pertaining to the importation of unlicensed veterinary biologics, may be directed to Canadian Centre for Veterinary Biologics.
