Veterinary Biologics Guideline 3.21.2E:
Guideline for the Importation of Unlicensed Veterinary Biologics Manufactured in a Foreign Country
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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 may apply for the CCVB's permission to obtain a veterinary biologic that is unlicensed in Canada, for use under their supervision in research or in emergency situations. For product manufactured in a foreign country, importation for restricted use under veterinary supervision is authorized by issuing a Permit to Import Veterinary Biologics to the veterinarian.
The veterinarian who applies for a Permit to Import Veterinary Biologics must provide the CCVB with adequate justification for the importation and use of the unlicensed product in Canada. The CCVB reviews applications to import unlicensed products on a case-by-case basis. Permits to import unlicensed veterinary biologics are generally issued for specific serials (batches) of product. However, some in vitro diagnostic test kits are not limited by this serial-specific restriction. In accordance with the Health of Animals Regulations, imported product must be shipped directly from the manufacturer or authorized exporter that is identified on the import permit, not from unregulated third parties, to the address identified on the permit.
II. Legal Authority
Health of Animals Regulations, Part XI:
- 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.
- 121.(1.1) Where a permit referred to in subsection (1) has been issued, the veterinary biologic shall be shipped directly to Canada from the manufacturer's premises or from such other premises, in which veterinary biologics may be lawfully manufactured under the applicable foreign laws, that were designated in the application for the permit.
- 122.(1) Subject to subsection (2), every applicant for a permit to import a veterinary biologic into Canada shall include with his application
- (h) 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.
- 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. Application Process
An application for a Permit to Import Veterinary Biologics for research or emergency use must include the following documents. The documentation may be faxed or mailed to the CCVB.
A. Information Provided by the Veterinarian
Note: Prior to submitting a permit application to the CCVB, veterinarians should confirm that the manufacturer of the unlicensed product being sought is willing and able to ship the requested product, and prepared to provide the CCVB with the required supporting documents, including product information, samples of labelling, and test results for the serial(s) to be imported.
1. Covering letter from the veterinarian: The application must include a letter, signed by the veterinarian, briefly explaining the rationale for importing and using the unlicensed product in Canada. The following details should be provided:
- Information about the unlicensed veterinary biologic being sought, including the manufacturer's name.
- The reason for deciding to use the proposed unlicensed product. For vaccines or antibody products for use 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, and the success or failure rate. For diagnostic test kits, include information on why similar licensed kits, if available, are unsuitable.
- Confirmation that the product will be used under the veterinarian's supervision.
- Confirmation that the veterinarian and clients are aware that the product is not licensed and has not been fully evaluated for safety and efficacy by CCVB, and that the veterinarian will use it at the owner's and veterinarian's risk.
- The number of doses or vials, or diagnostic tests or kits to be imported.
- The name and address of the farms, clinics, or laboratories where the product will be used.
- Veterinarians must declare that they are willing to use the product and that they accept full responsibility for providing appropriate instructions to anyone using the veterinary biologic under their supervision, even in those instances when bilingual English-French labelling is unavailable.
3. Form CFIA/ACIA 4720 – Application for Services: Submit this form, along with the applicable cost-recovery fee ($60). [Use Regulation Item No. 4(a) for research use or item 4(b) for emergency use.]
B. Information Provided by the Manufacturer
Items 4 to 10 may contain confidential business information, and are ordinarily submitted directly to the CCVB by the manufacturer. Submission is required only when requested by the CCVB, as some documents may already be on file from previous permit requests.
4. USDA Veterinary Biologics Establishment License or other country's equivalent document: Product imported from the U.S. must be produced in a facility licensed by the United States Department of Agriculture Center for Veterinary Biologics (USDA-CVB). 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 U.S. for emergency use must be licensed for use in the U.S. by the USDA-CVB, or otherwise approved for restricted use in the U.S. or for export. 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 document describes the materials and procedures that are used for preparing and testing the product, and serves as a contract between the manufacturer and regulatory agencies.
7. Summary of test results or equivalent document: When requested by the CCVB, the manufacturer must submit a summary of the test results for the serials (batches) to be imported into Canada.
- Product imported from the U.S.: Manufacturers should submit a copy of the APHIS Form 2008: Veterinary Biologics Production and Test Report, bearing the USDA-CVB's disposition for the serial. This document verifies that the serial has been tested, found satisfactory, and released for sale by the USDA-CVB.
- Product imported from other countries: Manufacturers should submit an official summary of test results, batch release certificate, or equivalent documentation, signed by the "Qualified Person."
8. Product labels: In some cases, the CCVB may have specific requirements, such as using the statement, "For experimental use only" or "Not for sale in Canada."
9. Information on the materials of animal origin: The manufacturer must provide a list of all materials of animal origin used in preparing the veterinary biologic, including the ingredients of the media on which master seeds were grown. For each ingredient, 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 should be given (e.g. Trypsin – porcine – pancreas – Poland – ABC Inc., U.S.). This information helps characterize the product's potential risks for contamination with extraneous micro-organisms and transmissible spongiform encephalopathy agents.
10. Declaration of Compliance signed by the manufacturer: To obtain sample text for the Declaration of Compliance, refer to Appendix I of the Veterinary Biologics Guideline 3.32E: Guideline for Minimising the Risk of Introducing Transmissible Spongiform Encephalopathy Agents Through Veterinary Biologics.
Note that the CCVB may request additional documents, such as experimental protocols, facility inspection or certification reports, environmental assessments, and summary of suspect adverse reaction reports/vaccine-vigilance data, from the veterinarian or manufacturer, as appropriate. The CCVB additionally reserves the authority to inspect holders of Permits to Import Veterinary Biologics to verify compliance with the Health of Animals Regulations and permit conditions.
IV. Additional Information
Any further questions from manufacturers and veterinarians, or requests for clarification regarding the regulations and requirements pertaining to the importation of unlicensed veterinary biologics, may be directed to the CCVB.
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