VB-GL-3.21.2: Importation of unlicensed veterinary biologics manufactured in a foreign country

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1. 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 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 products manufactured in a foreign country, importation for restricted use under veterinary supervision is authorized by the CCVB by issuing a permit to import veterinary biologics to the veterinarian.

The veterinarian who applies for an import permit for an unlicensed veterinary biologic for research or emergency use 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.

1.1 Legal authority

The Health of Animals Regulations (Part XI – Veterinary Biologics – Sections 121.(1), 121.(1.1), 122.(1) and 131.1(1)) confer the legislative authority to regulate the import of unlicensed veterinary biologics into Canada:

2. Application process

An application for a permit to import an unlicensed veterinary biologic for research or emergency use must include the supporting documents and forms identified below. The documentation may be emailed, faxed or mailed to the CCVB c/o PASO, as stated on Form 4720.

2.1 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.

Form CFIA/ACIA 5986 – Veterinarian's application for an import permit for an unlicensed veterinary biologic for research or emergency use

In CFIA/ACIA 5986, the veterinarian is required to briefly provide a rationale to use the unlicensed product in Canada and must attest to the following statements:

  • The product will be used under the veterinarian's supervision
  • The veterinarian and clients are aware that the product is not licensed in Canada pursuant to the Health of Animals Act and regulations, and has not been fully evaluated for safety and efficacy by the CCVB
  • The product will be used at the owner's and veterinarian's risk
  • The veterinarian accepts 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
  • The veterinarian and importer will follow all conditions listed on the import permit

Form CFIA/ACIA 4720 – Application for services

Submit form CFIA/ACIA 4720, along with the applicable cost-recovery fee:

  • Select service option number 4(a) for research use or option 4(b) for emergency use.

2.2 Information provided by the manufacturer

Note: Items below 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.

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 produced in a facility licensed by the pertinent regulatory authority in that country.

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. Requests to import unlicensed product for research use will be considered on a case-by-case basis.

Manufacturer's Outline of Production 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.

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 or the electronic form: Veterinary biologics marketing notification and 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".

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."

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 (for example, 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.

Declaration of compliance signed by the manufacturer

To obtain sample text for the Declaration of Compliance, refer to Appendix I of VB-GL-3.32: Minimising the risk of introducing transmissible spongiform encephalopathy prions and other infectious agents through veterinary biologics.

Note: 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.

3. 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.