Veterinary Biologics Guideline 3.33
Guideline for Commercial Importers of Veterinary Biologics in Canada
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Table of Contents
- I. Introduction
- II. Legal Authority
- III. Requirement for an Import Permit
- IV. Applying for a Commercial Import Permit
- V. Facility Inspection
- VI. Annual Renewal of an Import Permit
- VII. Facility Relocation
- VIII. Cessation of Import Activities
- IX. Related Guidelines and References
- X. Additional Information
Veterinary biologics include vaccines, antibody products and test kits used for the prevention, treatment or diagnosis of infectious diseases of animals. These products are regulated by the Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA), under the authority of the Health of Animals Act and Regulations. The CCVB is responsible for licensing veterinary biologic products and for regulating their importation, distribution and use. Once a veterinary biologic manufactured outside Canada is licensed by the CCVB, a commercial import permit is issued to the Canadian importer, designated by the manufacturer, to facilitate distribution and sale of the product in Canada. The designated Canadian importer is responsible for ensuring compliance with regulatory requirements of the Health of Animals Act and Regulations regarding the importation, storage, distribution and sale of veterinary biologic products, and with the conditions stipulated on their import permits.
This guideline is primarily intended for new importers; however, the standards also apply to existing facilities.
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.
(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 (4) Every person to whom a permit is issued to import a veterinary biologic shall
- keep and make available for inspection by a veterinary inspector a record in a form approved by the Minister with respect to the importation, sale and distribution of the veterinary biologic and retain that record for at least two years following the expiration date of the veterinary biologic to which the record relates; and
- furnish the Minister with such samples of the veterinary biologic as the Minister may require from time to time.
130.1 Every veterinary biologic imported, sold, advertised or offered for sale in Canada shall be stored at a temperature between 2°C and 7°C unless otherwise stated in the product outline or the labelling.
131 Where the Minister is satisfied from tests of a veterinary biologic, or otherwise, that a veterinary biologic is unsafe to use, is likely to cause communicable disease in animals or is contaminated or ineffective, he may, by order, prohibit the importation, manufacture, sale or distribution of the veterinary biologic.
132(1) No person shall import, sell, advertise, or offer for sale a veterinary biologic unless it is packed and labelled in accordance with these Regulations.
134.1 No person shall sell or offer for sale a veterinary biologic after its expiration date.
134.2(1) Except as provided in subsection (2), no person shall sell or offer for sale a rabies vaccine to anyone other than a veterinarian of the Department of Agriculture of Canada or a veterinarian who holds a valid licence to practice veterinary medicine issued by the veterinary licensing body of a province.
135(1) No person shall, in any advertisement for the sale of a veterinary biologic, make any claim with respect to the purity, safety, potency and efficacy of the veterinary biologic that is not supported by the product outline for such veterinary biologic.
135.1 Every holder of a licence or permit issued under this Part shall report to the Minister, in writing, any information concerning or any evidence of, a significant deficiency in safety, potency or efficacy of a veterinary biologic within 15 days after the date on which that information or evidence is known to the holder.
III. Requirement for an Import Permit
The importation of any veterinary biologic into Canada requires a valid import permit issued by the CCVB. There is no exemption from the import permit requirement for small shipments, personal use, or for emergency or research use.
Commercial import permits for veterinary biologics are issued by the CCVB only to the importer(s) designated by the manufacturer of a product. A foreign manufacturer may designate more than one importer in Canada and, in this case, each importer is required to obtain a separate import permit. An importer may obtain import permits for the importation of veterinary biologics from more than one foreign manufacturer. An importer must be a Canadian entity with a Canadian address.
Imported veterinary biologic products must be shipped directly from the manufacturer, from the address(es) listed on the import permit, to the importer's Quarantine Destination or Other Destination site identified on the import permit. The importation of veterinary biologics from wholesale dealers, retail outlets, or Internet pharmacies is not permitted.
Commercial import permits for veterinary biologics are generally valid for one year, and must be renewed on an annual basis by April 30.
Commercial importers are subject to inspection by the CFIA, and are responsible for complying with the regulatory requirements related to veterinary biologics importation, storage, distribution and sale, which are set out in the Health of Animals Act and Regulations, and with the conditions stipulated on their import permits.
IV. Applying for a Commercial Import Permit
The following documents are required to support an application for becoming a new commercial importer of veterinary biologic products. Additional documents may be required to support the application.
A. The following documents must be submitted to the CCVB, Ottawa, to open a new application:
1. Covering letter introducing the importing company, its intentions for importing veterinary biologics, and identifying the person who will serve as the regulatory liaison.
2. Form CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada – signed by the importer's designated contact person.
3. Form CFIA/ACIA 1503 – Veterinary Biologic Information – signed by the regulatory affairs representative of the foreign manufacturer.
4. Form CFIA/ACIA 4720 – Application for Services – and the applicable cost recovery fee for issuance of an import permit. Please contact the CCVB for advice on which cost recovery fee is applicable.
B. Once receipt of the application has been acknowledged by the CCVB, the applicant must submit the following documents directly to the CFIA Veterinary Biologics Operations (VBO) Veterinarian responsible for the area in which the importer is located.
1. Organizational chart and personnel responsibilities – Identify the key personnel involved in the management of veterinary biologics, along with their reporting relationship and main duties. Depending on the size of the company, this may include the company's manager and/or director, the main CCVB/VBO contact, and the person(s) primarily responsible for:
- Regulatory affairs;
- Quality assurance;
- Equipment monitoring and maintenance (e.g. coolers, refrigerators, autoclave, liquid nitrogen tanks);
- Warehouse storage and quarantine areas;
- Decisions regarding returned products;
- Decisions regarding temperature deviations;
- Oversight of stop sales and product recalls; and
- Reporting suspected adverse events/reactions to the CCVB.
The backup persons for these key responsibilities should also be identified.
2. Facility plot plan – Identify the physical location of each building and structure on the premises, the surrounding area, and adjacent buildings and structures. Include the location of property boundaries, access routes, parking area(s), loading dock, and a directional indication. Provide the business types and names of the occupants of directly adjacent properties. An aerial photo or satellite image can be a useful starting point for preparing the plot plan.
3. Blueprint or site plan – Identify on the blueprint or site plan for a building all rooms in which veterinary biologics are imported, received, packaged, stored, distributed, and/or disposed, and assign a code (number/letter) to each room. Identify the designated quarantine area(s). Indicate the location of each large piece of equipment essential to veterinary biologics (e.g. walk-in cooler, refrigerator, freezer, autoclave), including any equipment attached to the building (e.g. generator, liquid nitrogen tanks) that is used for veterinary biologics, and assign an identifying equipment code (number/letter).
4. Blueprint/Site Plan Legend – Provide a list of the rooms identified on the blueprint/site plan and describe each room's function in the blueprint legend. Include in the legend a room-wise list of the large equipment used for veterinary biologics.
Note: Each of the documents requested in items B.1 to B.4 above should include the following information:
- Title of the document (e.g. Plot Plan, Organizational Chart);
- Name and address of the company;
- Name and signature of the person who is responsible for these documents; and
- Date that these documents were prepared.
5. Information on key operational procedures – Importers must have written, clear, detailed procedures or work instructions for each of the activities listed below. Generally these will take the form of Standard Operating Procedure (SOP) documents. In addition to describing how tasks are done, these documents should identify the company personnel (by position title) primarily responsible for ensuring the activities are performed appropriately.
Monitoring the temperature of the veterinary biologic during storage. This should include information on the temperature-monitoring methods, including the frequency of monitoring, record keeping, acceptable limits, and the notification procedure and action to be taken in the event of a temperature deviation.
Note: Facilities must have at least a certified minimum and maximum thermometer for recording temperature in degree Celsius (°C). The minimum and maximum temperature of the storage area must be recorded on a daily basis, and records must be maintained for review during the inspection of the facility.
- Monitoring, maintaining and repairing critical equipment (e.g. walk-in coolers, freezers, liquid nitrogen tanks, backup generator), including an emergency backup plan.
- Receiving, secure storage, inventory control and traceability of the product. This should include information on how the importer plans to be able to identify end-users if necessary for a recall.
- Ensuring that the imported veterinary biologics have CCVB-approved labels before releasing the product for sale in Canada.
- Ensuring that each serial (or lot) of the imported veterinary biologics has been serial-released by the United States Department of Agriculture Center for Veterinary Biologics (USDA-CVB) or the CCVB, as appropriate, before releasing the product for sale in Canada.
- Ensuring that veterinary biologics are not sold beyond their expiration dates.
- Shipping product to customers. This should include information on maintenance of the cold chain and protection from freezing and elevated temperatures.
- Handling customer complaints and reporting suspected adverse events/reactions. This should delineate the relative roles and responsibilities of the importer and manufacturer in investigating and reporting suspected adverse events (SAE) to the CCVB. More information on the requirements for reporting SAEs to the CCVB can be found in Veterinary Biologics Guideline 3.15: Guideline for Reporting Suspected Adverse Events Related to Veterinary Biologics.
- Stop sales and product recalls. This should, in particular, identify the company position responsible for notifying the CCVB of any voluntary stop sale or recall actions.
- Disposing biomedical waste, returned product, and outdated inventory.
- Handling product returned from customers.
- Sanitizing the facility and equipment, and controlling vermin.
Note: It is expected that importers develop more detailed SOPs over time, as well as prepare SOPs for activities in addition to those listed above, as they gain experience handling imported veterinary biologic products.
6. Written agreement between importer and foreign manufacturer. This quality agreement should cover items such as:
- Relative roles and responsibilities of each party for investigating and reporting suspected adverse events.
- Manufacturer's agreement to inform the importer of stop sales or recall actions potentially affecting serials shipped to Canada.
- Responsibility for notifying CCVB of stop sale or recall actions.
- Manufacturer's agreement to provide the importer with copies of the CCVB stamped-approved labels for each veterinary biologic product listed on the import permit.
- Manufacturer's agreement to provide the importer with documentation from the USDA-CVB or CCVB showing each imported serial of product has been serial-released by the responsible regulatory authority.
7. Written agreement between importer and any contracted regulated warehouse. This quality agreement should cover items such as:
- Relative roles and responsibilities of each party for inventory control.
- Responsibility for verifying serial release documentation and labelling on product.
- Responsibility for verifying pseudorabies and bluetongue virus exclusion test results (if applicable).
- Decisions regarding product disposition following temperature deviation or other event.
- Confirmation that the warehouse agrees to be inspected by the CFIA and will comply with CFIA requirements.
Once the documents described in points B.1 to B.7 are received, reviewed, and found satisfactory by the Area VBO Veterinarian, he/she will notify the CCVB to proceed with processing the commercial import permit application. Additional documents may be required to complete the application process.
V. Facility Inspection
New importer facilities are typically inspected within 6 months of the importer receiving its first commercial import permit. The Area VBO Veterinarian will contact the designated Canadian importer to arrange for an inspection of the new facility. For additional information on importer inspections, please consult Veterinary Biologics Guideline 3.24: Guideline for Inspection of Veterinary Biologics Importers.
Importer facilities are generally inspected every one to three years. The CFIA's inspection frequency for a given facility will be based on risk, taking into account factors such as the number of products imported, the volume of business conducted, the complexity of operations at the facility, previous inspection findings and compliance history.
In accordance with the Canadian Food Inspection Agency Fees Notice, Part 11, importers are required to pay a fee for the inspection (currently $380 + HST/GST).
VI. Annual Renewal of an Import Permit
Commercial import permits must be renewed on an annual basis, by April 30 of each year. For instructions on how to renew an import permit, importers should consult the current year version of the Memorandum for Renewal of Veterinary Biologics Establishment Licences, Product Licences, and Import Permits, which will be posted on the CFIA's Veterinary Biologics Memoranda web page. Renewal notices are distributed by CCVB in late January or early February.
Please note that Canadian importers must inform their Area VBO Veterinarian of any major change in their facility or operating procedures. To maintain communication with the importers, the designated Area VBO Veterinarian may contact importers between inspections.
VII. Facility Relocation
Canadian importers must inform the CFIA when they plan to relocate to a new facility. The import permit will need to be amended to update the facility address, and the new facility will need to be inspected. The forms and documents listed in section IV of this guideline will, in essence, have to be resubmitted for approval of the new facility.
VIII. Cessation of Import Activities
Canadian importers who no longer intend to import any veterinary biologics are asked to provide their responsible Area VBO Veterinarian with the following:
1. A letter indicating: a) the current inventory of product under the control of the importer, with expiry dates; and b) the date the importer stopped, or will stop, distributing already imported product.
2. A copy of correspondence from the importer to the manufacturer advising the manufacturer to no longer ship product to the importer.
IX. Related Guidelines and References
Please consult the CCVB website for more information about the veterinary biologics regulatory program, and Canada Border Services Agency Memorandum D1-4-1 for invoice requirements pertaining to commercial goods imported into Canada.
X. Additional Information
Further questions from manufacturers and importers, or requests for clarification regarding requirements for importing veterinary biologics for non-commercial purposes or unlicensed veterinary biologics, may be directed to an Area VBO Veterinarian or the CCVB.
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