Veterinary Biologics - Questions and Answers
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Q1. What is a veterinary biologic?
Veterinary biologics are animal health products such as vaccines, antibody products, and in vitro diagnostic test kits that are used for the prevention, treatment, or diagnosis of infectious diseases in animals, including domestic livestock, poultry, pets, wildlife, and fish.
The Health of Animals Act defines a veterinary biologic as follows:
veterinary biologic means a thing that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state – or its symptoms – in animals and that is:
- (a) a helminth, protozoa or micro-organism,
- (b) a substance or mixture of substances derived from animals, helminths, protozoa, micro-organisms or plants, or
- (c) a substance of synthetic origin
Q2. Which government agency regulates veterinary biologics in Canada?
In Canada, veterinary biologics are regulated by the Canadian Food Inspection Agency (CFIA), under the legislative authority of the Health of Animals Act and Health of Animals Regulations. The veterinary biologics regulatory program is administered by the Canadian Centre for Veterinary Biologics (CCVB), in collaboration with the CFIA's Veterinary Biologics Operations (VBO).
Q3. What documents and data are required for veterinary biologics licensure in Canada?
To meet the requirements for licensure, a veterinary biologic must be shown to be pure, potent, safe, and effective when used in the target species according to the manufacturer's label recommendations. The licensing submission must also contain data demonstrating that the product can be manufactured and used without adversely affecting animal health, human health, food safety or the environment. A risk-based approach is used to evaluate the efficacy and safety of the product in the target species, as well as the potential detrimental effects for non-target species, humans and the environment.
Purity of a final biological product is the quality or condition of being free from extraneous micro-organisms and substances as determined by established test methods.
Potency is a measure of the relative strength of a biologic when tested by established methods which are documented in the production outline. It should correlate with the immunogenicity/efficacy of the biologic.
Safety means the freedom from properties causing undue local or systemic reactions, when used as recommended.
Efficacy is a measure of the specific protective capacity of the biologic when used according to label recommendations.
Q4. What is required for regulatory approval of in vitro diagnostic test kits in Canada?
Diagnostic test kits that are represented for use in the diagnosis of infectious diseases in animals are regulated as veterinary biologics. To meet the requirements for licensure as a veterinary biologic, an in vitro diagnostic test kit is evaluated on its specificity, sensitivity, repeatability and reproducibility. Since these products are not administered to animals, in vitro diagnostic test kits are exempt from the veterinary biologics animal safety testing requirements; however, certain test kits may require special biocontainment facilities for their use and/or decontamination prior to disposal if the test reagents or diagnostic samples contain infectious agents or hazardous chemicals. Diagnostic test kits intended for regulatory testing, such as kits for diagnosing rabies, bovine spongiform encephalopathy, or foreign animal diseases will have additional licensing requirements and restrictions for use.
Unlicensed laboratory reagents and tests that are utilized for research and internal quality control within laboratories may be exempt from the veterinary biologics licensing requirements, provided they are only produced for use within the laboratory, and the diagnostic tests and reagents are not represented as a veterinary biologic for diagnosis of infectious diseases in animals.
Unlicensed in vitro tests that are used as in-house diagnostic tests are considered to be veterinary biologics, and must conform to the principles outlined in the Health of Animals Act and Regulations, and technical standards in CCVB guidance documents. However the CCVB does not review and approve in-house in vitro diagnostic tests and reagents, provided that they are not represented as licensed veterinary biologics.
Specificity of an in vitro diagnostic test kit is its ability to detect animals that have not been exposed to the infectious agent ("non-diseased").
Sensitivity of an in vitro diagnostic test kit is its ability to detect animals that have been exposed to the infectious agent ("diseased"). Test results need to be interpreted with the clinical history of the animal.
Repeatability of an in vitro diagnostic test kit is the ability of the kit to produce the same results for particular samples, regardless of the number of times the test is done.
Reproducibility of an in vitro diagnostic test kit is the ability of the kit to produce the same results for particular samples when tested by independent laboratories according to the manufacturer's instructions.
More information is available in Veterinary Biologics Guideline 3.19: Guidelines for Licensing of Veterinary Diagnostic Test Kits in Canada.
Q5. How long does it take for a veterinary biologic to be licensed in Canada?
CFIA-CCVB has established service standards outlining target response times for the evaluation of incoming submissions. The time required for a veterinary biologic to gain full licensure in Canada can vary, because the evaluation process depends on several factors, including the timeliness of manufacturer responses to CFIA-CCVB's questions. Following receipt of a licensing application, CFIA-CCVB typically completes its initial evaluation within 120 days. Any supplemental data are usually evaluated within six weeks after receipt. In general, veterinary biologics requiring confirmatory laboratory testing will take longer to evaluate and license compared to those products for which the evaluation only involves the review of documents and data.
To help facilitate the timely evaluation and approval of submissions, applicants are encouraged to follow all CFIA-CCVB guidelines pertaining to their application, ensure that all relevant documentation is organized and complete, and ensure that the required number of samples are submitted in a timely manner when requested by the CFIA-CCVB.
Q6. What licences are required for the manufacture of veterinary biologics in Canada?
Canadian manufacturers of veterinary biologics are required to hold a valid Canadian Veterinary Biologics Establishment Licence and a corresponding Canadian Veterinary Biologics Product Licence listing all products produced for sale or distribution.
Q7. What licences or permits are required for foreign manufactured veterinary biologics to be distributed in Canada?
To apply for Canadian licensing, all imported products must be manufactured and tested in a regulated veterinary biologics manufacturing facility, in accordance with the foreign country's veterinary biologics facility licensing requirements and product licensing requirements. The foreign country's regulatory approval could be for unrestricted sale within that country, or it could be to authorize manufacturing for export-only sale to importers in other countries.
Foreign manufacturers wishing to sell/distribute veterinary biologics in Canada must designate a Canadian importer to serve as their legally responsible Canadian representative.
The designated Canadian importer must have adequate storage and distribution facilities, personnel, and document control systems, as outlined in Veterinary Biologics Guideline 3.24: Guidelines for Inspection of Veterinary Biologics Importers.
If all requirements for the Canadian licensing of the foreign manufactured veterinary biologic are met, then the designated Canadian importer(s) will be issued a Permit to Import Veterinary Biologics to allow the importation of the product into Canada from the manufacturer's facility.
More detailed information on document and data requirements for licensing veterinary biologics in Canada can be found in Veterinary Biologics Guideline 3.1: Guidance for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics.
Q8. Where can I check to see if a particular veterinary biologic is available in Canada?
The CFIA-CCVB maintains a list of licensed (approved) veterinary biologics on its Website. For information on the current availability of a particular licensed veterinary biologic, please contact the manufacturer or the Canadian importer.
Q9. Can I buy rabies vaccine and administer it to my own animals?
No. The federal Health of Animals Regulations [Section 134.2] prohibit the sale of rabies vaccines to non-veterinarians in Canada. This law allows exceptions to be made for rabies vaccination in remote areas without veterinary services, or for some temporary rabies vaccination clinics. You may contact the CFIA-CCVB if you think this exception would apply to your intended use, and we would discuss your request with the applicable veterinary licensing authority. Normally this permission is only granted to public health authorities in remote communities, or for trap-vaccinate-release programs run by provincial wildlife officials. Since rabies vaccination of pets is important to protect people from rabies as well as to protect their pets, many provinces have legislation that require pets be certified vaccinated by veterinarians.
Veterinary Biologics and Veterinary Drugs
Q1. What is the difference between veterinary biologics and veterinary drugs?
Veterinary biologics include veterinary vaccines and antibody products used to treat or prevent infectious diseases in animals, as well as diagnostic test kits for the diagnosis of infectious diseases in animals. Veterinary biologics are regulated by CFIA-CCVB under the authority of the Health of Animals Act and Regulations.
The mode of action of a veterinary biologic involves an immunologic response to a particular infectious disease agent. If manufactured in Canada, the label of a veterinary biologic bears the Canadian Veterinary Biologics Establishment Licence number. If manufactured in the United States of America, the label bears the United States Veterinary Biologics Establishment License number.
Veterinary drugs include substances, or mixtures of substances, manufactured, sold or represented for use in the diagnosis, treatment, mitigation, or prevention of disease, disorder or abnormal physical state, or its symptoms in animals. Veterinary drugs may also be used for restoring, correcting or modifying organic function in animals. Veterinary drugs include antibiotics, antiparasitics, sedative and anaesthetic agents, antipyretics, etc. Veterinary drugs are regulated by the Veterinary Drugs Directorate of Health Canada under the authority of the Food and Drugs Act and Regulations. If licensed in Canada, a veterinary drug label bears a drug identification number (DIN).
Q2. My company is already approved by Health Canada's Veterinary Drugs Directorate to manufacture veterinary drugs. Why do I need to apply for a separate CFIA Veterinary Biologics Establishment Licence to manufacture veterinary biologics?
Facilities manufacturing veterinary biologics are regulated under the Health of Animals Act and Regulations,whereas facilities manufacturing veterinary drugs are regulated under the Food and Drugs Act and Regulations. To be in compliance with the Health of Animals Act and Regulations, veterinary biologics must be manufactured in a facility holding a Canadian Veterinary Biologics Establishment Licence. The manufacturing of veterinary biologics typically involves the handling of live organisms, many of which are pathogenic to animals, and some of which are also pathogenic to humans. Consequently, the manufacturing and biocontainment requirements for a veterinary biologics manufacturing facility may be different from that of a facility manufacturing veterinary drugs.
Q1. Can I import veterinary biologics into Canada?
Veterinary Biologics can be imported into Canada, but only with a valid Permit to Import Veterinary Biologics. For licensed products, these are issued by CFIA-CCVB to the Canadian importer(s) designated by the product manufacturer. Import permits can also be issued to licensed Canadian veterinarians for emergency or research use if an appropriate product is not already licensed and distributed in Canada.
There is no exemption from the import permit requirement for small shipments of veterinary biologics that are intended for "personal use".
Health of Animals Regulations:
"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."
More information on the importation of veterinary biologics into Canada is available in Importation of Veterinary Biologics - Overview.
Q2. Can I get an import permit for a veterinary biologic manufactured in another country and licensed in Canada?
When a veterinary biologic is licensed in Canada but produced by a foreign manufacturer, it is up to the foreign manufacturer to identify potential Canadian importers. Suitable designated importers will be issued a Permit to Import Veterinary Biologics by the CFIA-CCVB. If you would like to be named as a designated importer, please contact the manufacturer of the products in which you are interested. There are specific procedures that importers must follow. Importers of veterinary biologics in Canada may be subject to inspection by veterinary inspectors from the CFIA Veterinary Biologics Operations.
More details on the standards that a veterinary biologics importer-distributor must meet can be found in Veterinary Biologics Guideline 3.33: Guideline for Commercial Importers of Veterinary Biologics in Canada.
Q3. How can I obtain an import permit for an unlicensed veterinary biologic?
Under certain circumstances, Canadian veterinarians can apply for permission to import a veterinary biologic that is unlicensed in Canada for use under their supervision in research or emergency situations. The importation and use of unlicensed veterinary biologics must be justified by the importing veterinarian. Applications to import unlicensed products are reviewed on a case-by-case basis. Imported unlicensed veterinary biologics must be shipped directly from the manufacturer's premises.
More information on the importation of unlicensed veterinary biologics into Canada can be found in Veterinary Biologics Guideline 3.21: Guideline for the Importation of Veterinary Biologics for Research or Emergency Use.
Q4. I can order veterinary biologics from a U.S. Internet site and the company tells me that they can ship to Canada. Is this allowed?
No. Imported veterinary biologics can only be shipped from a manufacturer directly to its designated Canadian importer(s) or specific other destinations, which are specified on a Permit to Import Veterinary Biologics. The Health of Animals Regulations prohibit the importation of veterinary biologics from unregulated distributors.
"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.
(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."
If you are interested in purchasing a particular product, please consult the manufacturer to help locate a Canadian importer-distributor, or contact your veterinarian for advice.
Q5. I am an animal breeder. Can I buy a veterinary biologic from a U.S. veterinarian, keep it cold, and bring it to Canada?
No. An import permit is required to bring any veterinary biologic across the border into Canada. Due to the potential impact on animal health, human health, food safety, and the environment, some veterinary biologics are not permitted in Canada. Controlling the sale of veterinary biologics facilitates adverse reaction reporting, as well as the stop sale, trace-back, and/or recall of the imported veterinary biologic if there is a problem. Even if the veterinary biologic is licensed in Canada, the particular serial or batch that you buy may not have been released (authorized for marketing) for sale, distribution or import to Canada.
Q6. I have attempted to import a veterinary biologic without an import permit and it is being held at the border. Can I get a permit to bring the veterinary biologic into Canada?
No. A Permit to Import Veterinary Biologics must be obtained before importing a veterinary biologic into Canada.
The original or a copy of the signed original of an import permit and any other necessary import documentation pertaining to the shipment of a veterinary biologic must be provided for inspection at the first port of entry or to a CFIA Import Service Centre.
Q7. What are the penalties for illegally manufacturing or importing veterinary biologics?
The consequences for illegally manufacturing or importing veterinary biologics could be a substantial monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act, or prosecution under the Health of Animals Act or the Health of Animals Regulations. If the prosecution finds the alleged offender guilty, a monetary penalty could be imposed, and/or a jail term could be imposed (up to $50,000 and six months in jail for some offences in contravention of the Health of Animals Regulations, and up to $250,000 and two years in jail for contravention of the Health of Animals Act). For illegal importations, rejection or confiscation of the contravening product is common. The investigation and imposition of penalties for illegal manufacturing or importation of veterinary biologics are coordinated by the CCVB, VBO and the Enforcement and Investigation Services of the CFIA.
Q8. Why might a serial (batch) of a veterinary biologic not be released for sale in Canada if it is released for sale in the U.S.?
Canada has additional testing requirements for some veterinary biologics, and serials that have not undergone these additional tests are not eligible for importation into Canada. Some veterinary biologic products have labels specific for use in Canada. A manufacturer may decide to have only certain serials of a veterinary biologic undergo these additional tests and/or be labelled with its Canadian-specific labels. A company may additionally choose to sell a particular serial to only one region or country to facilitate any necessary recalls.
Inspection and On-Site Audit
Q1. Are manufacturers and importers given prior notice of upcoming inspections?
The CFIA may conduct unannounced inspections of regulated premises; however, in most cases, prior to conducting a routine inspection, manufacturers and importers are advised in writing of the date and cost recovery fee requirements for inspection of the regulated veterinary biologics facilities. This prior notice helps ensure that the appropriate managers and technical personnel will be available during the inspection. Manufacturers and importers may be requested to provide payment in advance of the inspection.
More information is available in Veterinary Biologics Guideline 3.11: Guideline for Inspection of Veterinary Biologics Manufacturers and Importers.
Q2. What is the objective and frequency of inspections?
To verify compliance with the Health of Animals Regulations and technical standards, veterinary biologics manufacturers and importers are inspected periodically.
Canadian manufacturers are typically inspected annually. Canadian importers are inspected every three (3) years, or more frequently if deemed necessary. Depending on the action items identified during an inspection, one or more follow-up inspections may also be conducted if warranted.
The CCVB inspects foreign manufacturers approximately every four (4) years. More frequent inspections may be necessary if there are major changes in the facilities or products.
Manufacturers located in the United States, which are licensed and inspected annually by the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) Center for Veterinary Biologics (CVB), are not routinely subjected to comprehensive in-depth inspections by the CFIA-CCVB; however, facilities producing veterinary biologics for program diseases, or manufacturing autogenous vaccines or products for export only with minimal USDA-CVB regulatory oversight, may be subjected to periodic inspections / on-site audits to verify compliance with Canadian veterinary biologics regulations and permit conditions, and to ensure that the regulated manufacturer is aware of Canadian regulatory requirements, and conforming to these requirements, as documented in product licensing data and reports filed with the CCVB.
Q3. When manufacturing and importing facilities are inspected, which personnel, documents, facilities, equipment and procedures will be inspected?
Under the Health of Animals Act and Health of Animals Regulations, a veterinary inspector is authorized to inspect the regulated company's supporting documentation and records to verify compliance with the regulations. During the inspection, the examination of documents and records is supplemented by inspection of the physical facilities, personnel, equipment, and manufacturing and testing procedures that are used in the regulated manufacturing or importing facility.
More information is available in Veterinary Biologics Guideline 3.11: Guideline for Inspection of Veterinary Biologics Manufacturers and Importers.
Q4. How will manufacturers and importers be advised of the inspector's findings and assessment?
At the end of an inspection, a closing meeting is held where the inspector verbally presents the inspection findings. Following the inspection, a written confidential inspection report outlining the inspection findings, action items and recommendations will also be provided to the company.
Suspected Adverse Events
Q1. To whom do I report a suspected adverse event (vaccine reaction) that occurs after the use of a veterinary biologic, or the failure of a diagnostic kit?
Suspected adverse events are generally reported by veterinarians to the product's manufacturer. The manufacturer is then required to investigate the case and report their findings to CFIA-CCVB. Users of veterinary biologics, or animal owners, may also report suspected adverse events to product manufacturers or directly to CFIA-CCVB. Animal owners reporting cases directly to CFIA-CCVB should also inform their veterinarian of the case.
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