VB-GL-3.33: Requirements for commercial importers of veterinary biologics in Canada

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1. Introduction

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 (VB) products and for regulating their importation, distribution and use. Once a VB 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 VB 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 VB products, and with the conditions stipulated on their import permits.

This guideline is primarily intended for new importers; however, these requirements also apply to existing facilities.

1.1 Legal authority

2. Requirement for a VB import permit

The importation of any VB 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 VB are issued by the CCVB only to the importer(s) designated by the manufacturer of a product. A foreign manufacturer may designate more than 1 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 VB from more than 1 foreign manufacturer. An importer must be a Canadian entity with a Canadian address.

Imported VB 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 VB from wholesale dealers, retail outlets, or internet pharmacies is not permitted.

Commercial import permits for VB are generally valid for 1 year, and must be renewed on an annual basis before the June 30 expiry date.

Commercial importers are subject to inspection by the CFIA, and are responsible for complying with the regulatory requirements related to VB importation, storage, distribution and sale, which are set out in the Health of Animals Act and regulations, and with the conditions stipulated on their establishment licences and import permits.

3. Applying for a new commercial VB importer establishment licence

The VB establishment licence application for new commercial VB importers can be accessed through the My CFIA portal. A My CFIA account is required to apply for, track and pay for a VB application. Companies should contact the Pre-market Application Submissions Office (PASO) if they require information about opening a CFIA billing account, a My CFIA account, or to pay by credit card.

The following documents are required to support an application to become a new commercial importer of VB products. Additional documents will be requested by the VB evaluator or area VB Operations (VBO) veterinarian assigned to the application.

Note: to support an online My CFIA application, it is recommended that applicants upload documents directly to the My CFIA portal. Multiple documents may be uploaded directly to the My CFIA portal provided each document does not exceed a file size of 20 Mb. Alternatively, the application can be opened in My CFIA with supporting documents either transmitted through a cloud or file hosting service, or emailed to the PASO office. Documents should be prepared as PDF files. Documents sent by email cannot exceed a total file size of 18 Mb per email.

Step 1

To open a new commercial VB importer application, the following documents must be submitted to the VB program through the My CFIA portal:

Cover letter: the cover letter should introduce the importing company, its intentions for importing VB, and identify the person(s) who will serve as the regulatory liaison(s). List the VB products being considered for import.

Letter from foreign VB manufacturer: a letter signed by a representative of the VB manufacturer serves to authorize the VB importer applicant to represent the foreign manufacturer in Canada for the purpose of import, storage, sale and distribution of the VB manufacturer's products in Canada.

Blueprint and plot plan with legends: refer to VB-GL-3.34: Requirements for veterinary biologics facilities for guidance.

On the 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.

On the blueprints or site plans identify, for each building, all rooms in which VB are imported, received, packaged, stored, distributed, and/or disposed, and assign a code (number or letter) to each room. Identify the designated quarantine area(s). Indicate the location of each large piece of equipment essential to VB (for example, walk-in cooler, refrigerator, freezer, autoclave), including any equipment attached to the building (for example, generator, liquid nitrogen tanks) that is used for VB. Assign an identifying equipment code (number or letter) to each piece of equipment that is used for VB.

A blueprint or site plan legend should accompany the blueprints to provide further details about each room for VB use. The legend should list the rooms identified on the blueprint/site plan, describe each room's function, list each room's equipment that is used for VB.

These documents should be appropriately titled and include the name and address of the importing company, the name and signature of the person responsible for the documents, and the date that the documents were prepared.

Organizational chart for key personnel: refer to VB-GL-3.28: Requirements for personnel involved in the manufacturing, testing, and importation of veterinary biologics for guidance. Identify the key personnel involved in the management of VB, 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 (for example, 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
  • reporting suspected adverse events/reactions to the CCVB

The organizational chart should be appropriately titled and include the name and address of the importing company, the name and signature of the person responsible for this document, and the date that the document was prepared.

Step 2

Once receipt of the application has been acknowledged by the CCVB, the applicant will be asked to submit the following documents directly to the VBO veterinarian responsible for the area in which the importer is located:

Operational procedures: importers must have clear, detailed written 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 VB during storage
    • Information on the temperature-monitoring methods, including the frequency of monitoring, record keeping, acceptable limits
    • 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
    • The CCVB and VBO may permit smaller importers to record VB storage temperatures on "business days" only
      • The VB importer will then assume the risk that it may have to destroy VB products if it is discovered on the next working day that a significant temperature deviation occurred during the weekend or on a statutory holiday
  • Monitoring, maintaining and repairing critical equipment (for example, walk-in coolers, freezers, liquid nitrogen tanks, backup generator)
    • Emergency backup plan in a situation of critical equipment or power failure.
  • Receiving, secure storage, inventory control and traceability of the product
    • Product recall procedure to the end-user
  • Verifying that the imported VB have CCVB-approved labels before releasing the product for sale in Canada
  • Verifying that each serial (or lot) of the imported VB 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 VB are not sold beyond their expiration dates
  • Shipping product to customers
    • Information on maintenance of the cold chain
    • Information on protection from freezing or elevated temperatures
  • Handling customer complaints and reporting suspected adverse events/reactions
  • Stop sales and product recalls
    • Identify the company position responsible for notifying the CCVB of any voluntary stop sale or recall actions
  • Disposing biomedical waste, returned VB product, and outdated inventory
  • Handling VB 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 VB products.

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 SAE
  • 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 VB 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 VB product has been serial-released by the responsible regulatory authority

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 contracted warehouse agrees to be inspected by the CFIA and will comply with CFIA requirements
  • confirmation that the contracted warehouse agrees to the sharing of its CFIA inspection reports with the importer

Step 3

Once the above documents are received, reviewed, and found satisfactory by the area VBO veterinarian, the CCVB will be notified to proceed with issuing the VB importer establishment licence and processing the commercial VB import permit application.

In accordance with the CFIA Fees Notice, Part 11, Number 40 to 50, VB importers are required to pay a fee for the initial commercial VB import permit and each listed VB product, and subsequently, for each import permit amendment and annual renewal.

At this time, commercial VB import permit applications may be submitted to be processed and issued by email, or via the My CFIA interim module. Additional documents and VB product-specific information may be required to complete the application process. For each licensed VB product intended for commercial importation the following forms are required:

Form CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada – signed by the importer's designated contact person.

Form CFIA/ACIA 1503 – Veterinary Biologic Information – signed by the regulatory affairs representative of the foreign manufacturer.

A form CFIA/ACIA 4720 – Application for services with the CFIA customer financial account number entered on the form should accompany the VB import permit application. Do not enter credit card information directly on the form.

4. Facility inspection

New VB importer facilities are typically inspected within 6 months of the VB importer receiving its first VB establishment licence and commercial VB import permit. The area VBO veterinarian will contact the importer to arrange for an inspection of the new facility. For additional information on importer inspections, please consult VB-GL-3.24:Inspection of veterinary biologics importers.

VB importer facilities, including their contracted regulated warehouse, are generally inspected every 1 to 3 years. The inspection frequency for a given facility will be based on risk, taking into account factors such as the number and types of VB 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, No. 40 to 50 importers are required to pay a fee for the inspection.

5. Annual renewal of a commercial VB import permit

Commercial VB import permits must be renewed on an annual basis before the June 30 expiry date. 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.

Please note that Canadian importers must inform their area VBO veterinarian of any major change in their facility or operating procedures. The CCVB can be notified of changes to the facility and its procedures by means of an application to amend a VB establishment licence on the My CFIA portal.

6. Facility relocation

Commercial importers of VB in Canada must inform the CFIA when they plan to relocate to a new facility or when a contracted regulated warehouse is added, changed, or removed from an agreement. The associated VB establishment licence and any commercial import permits will need to be amended to update the facility information. The forms and documents listed in section 3 of this guideline will need to be submitted for consideration and approval of a new facility. The commercial VB importer should apply for an amendment of facility information through their My CFIA account. The area VBO veterinarian will arrange to schedule the inspection of new facilities added to the establishment licence.

7. Cessation of VB import activities

Commercial importers of VB in Canada who no longer intend to import any VB should apply to cancel their VB establishment licence through their My CFIA account, or by contacting their responsible area VBO veterinarian. The following information is required to cancel the VB licence and related, commercial import permits:

  • A letter indicating:
    • the current inventory of VB product under the control of the importer, with expiry dates
    • the date the VB importer stopped, or will stop, distributing already imported product
  • A copy of correspondence from the VB importer to the VB manufacturer advising the VB manufacturer to no longer ship VB product to the importer.

8. Additional information

Please consult the CCVB website for more information about the VB regulatory program, as well as available Guidelines and forms. Consult the Canada Border Services Agency Memorandum D1-4-1 for invoice requirements pertaining to commercial goods imported into Canada.

Contact an area VBO veterinarian or the CCVB if you have additional questions or need clarification on regulations and requirements for commercial importation of licensed VB.

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