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Guidelines / Forms Veterinary Biologics Guideline 3.25E Guidelines for Importation of Veterinary Biologics
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Information Sheet - Importation of Veterinary Biologics into Canada
The manufacture and importation of veterinary biologics in Canada is regulated by the
Canadian Food Inspection Agency (CFIA) under the authority of the Health of Animals
Act and Regulations. Veterinary biologics include veterinary vaccines,
diagnostic tests for the diagnosis of animal infectious diseases and antibody products
used to treat or prevent animal infectious disease. Veterinary biologics do not include
veterinary drugs (which are assigned a DIN number) and are primarily regulated by Health
Canada (Veterinary Drugs Directorate) under the authority of the Food & Drugs Act
and Regulations.
Veterinary biologics are regulated to ensure that the products used in animals in
Canada are safe, effective, pure and potent. The manufacture of these products frequently
involves (at some stage) the use of live infectious disease agents that are modified or
killed during the manufacturing process. It is critical that credible processes with
appropriate controls are utilized and validated during the manufacture of these products
to ensure a safe end-product. All manufacturers of approved veterinary biologics that are
allowed to be licensed and/or imported for use in Canada, must first provide detailed
information about the effectiveness, safety and manufacturing to the CFIA-Veterinary
Biologics Section (VBS) for careful assessment and review by scientific experts. CFIA
inspectors also conduct on-site inspection of manufacturing facilities as part of this
review process.
Requirement for an Import Permit
A significant number of animal vaccines and diagnostic kits used in Canada, are
imported from other countries, including the United States, Europe, Australia and New
Zealand. Prospective importers must demonstrate that they utilize appropriate facilities
and expertise to manufacture veterinary biologics to conform with Canadian licensing
requirements, and that the country of origin has the required animal disease freedom
and/or surveillance systems to meet Canadian import requirements for animal products and
veterinary biologics.
The importation of any veterinary biologic into Canada requires a valid import
permit issued by the CFIA-VBS in Ottawa. There is no exemption from the import
permit requirement for small shipments, "personal use" or for emergency or
research use. (Reference Health of Animals Regulations Part XI Veterinary
Biologics, 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".)
Commercial Import Permits
Commercial import permits are only issued by the CFIA-VBS (Ottawa) for products which
are registered/licensed for use in Canada. For a list of veterinary
biological products licensed for use in Canada (please note that this list may not be
completely up-to-date).
Each product listed on a commercial import permit for veterinary biologics, has
undergone a scientific regulatory review. A detailed product file must be prepared by the
manufacturer and submitted to the CFIA-VBS for review. Furthermore, the product must be an
approved product (licensed/registered by the regulatory authorities) in the country of
origin. The product file contains research data, proprietary information concerning
production, testing, formulation and materials of animal origin as well as specifications
for storage, use, labelling, packaging, etc. The safety, purity, potency and efficacy of
the product must be demonstrated by the data and information submitted for review. Cost
recovery fees must be paid for the preliminary application review, in-depth consideration
of the application, and issuance of the initial commercial import permit (if the product
is accepted for registration by the CFIA). A satisfactory inspection of the manufacturing
facility and the proposed Canadian importer by a CFIA veterinary inspector is also a
requirement for product registration in Canada. These inspections are subject to fees for
service, as well as full recovery of inspection travel expenses.
The commercial import permit(s) for the product are issued only to the importer or
importers, designated by the manufacturer. Once the initial product review is completed
and the product is licensed/registered in Canada, subsequent renewal of the import permit
does not require the above in-depth review of the product file however the manufacturer
must submit data for on-going review to CFIA-VBS, to support any significant changes to
the production outline, label claims, designated importer, etc. and also must report any
suspected adverse events associated with the use of the product (post market
surveillance). In addition to the initial premises inspections, Canadian importers and
foreign manufacturers are subject to subsequent periodic facility inspections by CFIA
veterinary inspectors. The inspection frequency is determined by program requirements.
Frequently, the designated Canadian commercial importer is a subsidiary of the
manufacturer located in Canada. They usually provide distribution, marketing and technical
support to customers in Canada and may act as the regulatory affairs contact with the CFIA
on behalf of the manufacturer for reporting suspect adverse events, product recalls and
market withdrawal. A manufacturer may designate more than one importer and in this case
each importer is subject to inspection and must pay for and be issued an import permit.
Product must be shipped directly from the manufacturer to the designated importer. The
importer is subject to inspection and is responsible for complying with all conditions
stipulated on the import permit as well as the regulatory requirements related to
veterinary biologics in the Health of Animals Act and Regulations.
Emergency & Research Use Import Permits
Under certain special circumstances, Canadian veterinarians can apply to VBS for a
permit to import veterinary biologics which are unlicensed in Canada, for use under the
importing veterinarian's supervision, in research or emergency situations. These permits
may or may not be issued by CFIA-VBS, after a review of the rationale for use submitted by
the importing veterinarian and a case-by-case evaluation of specified minimum product
information. The permit (if granted) would specify conditions and requirements based on a
risk assessment of the product and its proposed use. This provision is restricted to
specific serials in the case of injectable products. Applications to import unlicensed
products are reviewed on a case-by-case basis and a decision is made to either allow or
refuse the importation. Imported products must then be shipped directly from the
manufacturer, and used under the supervision of the importing veterinarian.
In a covering letter sent to VBS along with the application and appropriate fee, the
importing veterinarian must briefly explain the rationale for importing and using
unlicensed product in Canada by providing the following information:
- The name and address of the farm(s) for which the product is being imported;
- The history of the disease situation - the incidence of disease on the farm(s); test
results of the affected animals on those farms; information on other vaccines/treatments
tried (or diagnostic kits used) and the success or failure rate.
- The reason for deciding to use this imported vaccine (or diagnostic kit)
- State the number of doses or vials (or diagnostic tests or kits) to be imported.
The veterinarian's letter must also confirm:
- That the product will be used under the supervision of the importing veterinarian;
- That the veterinarian and clients are aware that the product is not licensed and has not
been evaluated as a veterinary biologic in Canada and will be used at their own risk;
- That the product is being imported for investigational or emergency use.
All forms and more information concerning the above is
available on the web site.
Completed permit applications may be sent to:
Dr. Glen Gifford, National Manager
Canadian Food Inspection Agency
Animal Health & Production Division
Veterinary Biologics Section
2 Constellation Crescent, 8th Floor
Ottawa, ON K1A 0Y9
For General Inquiries: Telephone: 613-221-7566 Fax: 613-228-6612
Web contact
Information concerning import permits and the veterinary biologics program in Canada
may be obtained from the following Area contacts:
For Western Canada (Manitoba, Saskatchewan, Alberta & British Columbia):
Dr. Glen Gifford
Veterinary Biologics Veterinarian
Veterinary Biologics-Operations-West
Canadian Food Inspection Agency
Box 28, 247 - 111 Research Drive
Saskatoon, SK S7N 3R2
Telephone: 613-221-7595 Fax: 613-228-6612
For Ontario:
Dr. Ann West
Veterinary Biologics Veterinarian
Veterinary Biologics-Operations-Ontario
Canadian Food Inspection Agency
118071 Jackson Road, R. R. # 5
Owen Sound, ON N4K 5N7
Telephone: 519-371-4272 Fax: 519-371-7047
For Quebec:
Dr. Michel Morier
Veterinary Biologics Veterinarian
Veterinary Biologics-Operations-Québec
Canadian Food Inspection Agency
3100, Laframboise, bureau 206
St-Hyacinthe, QC J2S 4Z4
Telephone: 450-773-6639, ext : 119 Fax: 450-773-8338
For Atlantic Canada (Newbrunswick, Newfoundland & Labrador, Nova Scotia, Prince
Edward Island):
Dr. Thomas Wright
Veterinary Biologics Veterinarian
Veterinary Biologics-Operations-Atlantic
Canadian Food Inspection Agency
690 University Avenue
Charlottetown, PEI C1E 1E3
Telephone: 902-566-7290 Fax: 902-566-7334
Veterinary Drugs
Frequently there is confusion regarding the regulation of veterinary drugs. This
information is being provided to attempt to clarify the regulation of these drugs and
re-direct enquiries concerning these products. Veterinary drugs (which are not veterinary
biologics and can be readily identified as drugs by the presence of a DIN or Drug
Identification Number) are regulated by the Veterinary Drugs Directorate (VDD) of Health
Canada.
The Emergency Drug Release Program allows veterinarians to obtain limited quantities of
drugs not approved for sale in Canada, for emergency treatment under their direct medical
supervision. Veterinarians may ask the VDD, which may then recommend to the Health
Products & Food Branch, that the manufacturer be authorized to sell them a limited
quantity of the drug for emergency use. The manufacturer must provide adequate evidence to
the VDD that the drug poses no known health risk to the animals being treated or to
humans. The veterinarian assumes full responsibility for the safety of the animals treated
with the emergency drug and for any residue violations in food-producing animals as a
result of this use. More information concerning this is available on the VDD
website. |