Veterinary biologics services: Step 4. How to apply

Make a few selections to find out how to apply for veterinary biologics services.

To help make your choice for import permits and new product submissions, review:

Consult the following resources if the selection options don't fully address the type of service you're looking for:

Select a service type for more information:

 

Step 1: Confirm the unlicensed product can be shipped to Canada

Before applying for an import permit, veterinarians should confirm that the manufacturer of the unlicensed product being sought is:

  • willing and able to ship the requested product
  • prepared to provide the Canadian Centre for Veterinary Biologics (CCVB) with the required supporting documents, including product information, samples of labelling, and test results for the serial(s) to be imported

Step 2: Read the guidance

For specific details on the requirements to import unlicensed veterinary biologics in Canada, please refer to:

Step 3: Get your information ready

The CCVB reviews applications to import unlicensed products on a case-by-case basis.

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 veterinarian must fill out the Veterinarian's application for an import permit for an unlicensed veterinary biologic for research or emergency use (CFIA/ACIA 5986) (opens in new window) form, with attention to completing all requested attestations and justifications, as per guidance in VB-GL-3.21.2.

The CCVB may request more information from the manufacturer.

Importing rabies vaccines for use in remote communities

If you're applying for authorization to import rabies vaccines to sell for use in remote communities where veterinary services are not readily available, you'll need a separate form.

Please contact the Pre-market Application Submissions Office (PASO) (opens in new window) directly for more information.

Step 4: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Import Veterinary Biologics" service
  5. Follow the instructions to complete your application
    • Select "Emergency Use, Unlicensed Veterinary Biologic" or "Research Use, Unlicensed Veterinary Biologic" as the application sub type
    • The other application sub types are for products licensed for use in Canada and are for importers
    • Selecting the wrong application sub type may lead to the dismissal of your initial request and delay your application
  6. Add any comments that you think may be helpful in supporting your application
  7. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on what you need to import and produce autogenous veterinary biologics (VB) and prepare a licensing dossier, please refer to:

Step 2: Manufacturer must meet requirements

Veterinary biologics manufactures in the United States (U.S.) must get a licence and written approval from the Canadian Centre for Veterinary Biologics (CCVB) to produce autogenous or prescription platform products.

Licensed U.S. manufacturers prepare autogenous or prescription platform products for emergency use by or under the direction of a licensed veterinarian.

A valid veterinarian-client-patient relationship is a prerequisite for the use of autogenous and prescription platform products.

Step 3: Veterinarian applies for an import permit

The attending Canadian veterinarian must:

To apply for an import permit online:

  1. sign in to My CFIA
  2. select the validated party profile you want to use to apply for your service
  3. scroll to the "Service Request" tab and select the "New Service Request" button
  4. use the filters, keyword search or scroll to select the "Import Veterinary Biologics" service
  5. follow the instructions to complete your application
    • Select "U.S. Origin, Autogenous or Prescription Product" as the application sub type
    • Selecting the wrong application sub type may lead to the dismissal of your initial request and delay your application
  6. add any comments that you think may be helpful in supporting your application
  7. review and submit your application

Step 4: Manufacturer submits documents to the CCVB

Once we process the import permit request, we'll send a pre-approval or acknowledgement of the application to the attending veterinarian and the manufacturer.

When the vaccine is ready for import, the U.S. manufacturer must send the following documents directly to the CCVB:

  • summary of test results (U.S. form APHIS 2008) for the serial of autogenous VB to be imported
  • a copy of the label that will be used for the serial intended for use in Canada showing:
    • the name and address of the attending licensed veterinarian
    • serial number
    • expiration dating that shall not exceed 12 months from the date of harvest
  • the inactivation report for the specific serial of autogenous VB to be imported

The CCVB:

  • reviews each request for production and importation of an autogenous VB serial from the U.S. on a case-by-case basis
  • may request more information at the time of review
  • will issue a single-entry import permit to the attending veterinarian for a specific serial of the autogenous VB when the application is approved

The attending veterinarian must keep a copy of the permit on file and a copy of the permit must accompany each shipment.

Autogenous killed virus vaccine

For a serial of an autogenous killed virus vaccine, the attending veterinarian must submit their application to the CCVB before placing their order with the U.S. manufacturer.

The CCVB will pre-approve the production of the serial and relay this information to both the applicant and the U.S. manufacturer.

The U.S. manufacturer must submit the serial-specific test results, serial-specific label, and inactivation report directly to the CCVB once tests are completed, and before the CCVB will issue the import permit to the veterinarian.

Continue to My CFIA (opens in new window)

Step 1: Know the timelines

Annual import permits expire on June 30 every year.

Canadian importers should note that product licences for foreign manufacturers must be renewed before import permits for related products can be processed.

Step 2: Read the guidance

For specific details and requirements, please refer to:

Step 3: Apply online

For all manufacturers applying to renew an import permit in My CFIA:

  1. sign in to My CFIA
  2. select the validated party profile that has the permission you wish to renew
  3. scroll to the "Service Request" tab and select the "Renew a Permission" button
  4. select the permission number you wish to renew in the permission table
  5. select the "Renew" or "Renew with Changes" button (as applicable)
  6. follow the instructions and attach any required documents (as needed)
  7. enter any details of your requested changes (as applicable)
  8. submit your application and complete your payment in My CFIA (opens in new window) at least 2 weeks before your permit or licence expires

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

The manufacturer must provide the following information:

  • a cover letter identifying:
    • the veterinary biologics (VB) product, including the assigned name, trade name and Canadian Centre for Veterinary Biologics (CCVB) file number
    • any preservatives, inactivating agents and/or antibiotics
    • the indication for use, dose and administration
    • the importing country
    • any additional attestations requested by the importing country's regulatory agency and subject to review and approval by CCVB
  • a letter or other reference document from the importing country's regulatory authority specifying information to be included on the Veterinary Biologics Export Certificate
  • a complete application for services (CFIA/ACIA 4720) (opens in new window) form and applicable fees under item 11 for each certificate

There are additional requirements for serial-specific requests and export only products. Please consult the VB-GL-3.26 linked previously.

Veterinary biologics licensed for export only

For VB licensed in Canada as "For export only" (FEO), the Veterinary Biologics Export Certificate will specify that the product is:

  • manufactured in a licensed Canadian establishment
  • licensed for export only
  • not for sale in Canada

Step 3: Apply by email

Requests for Veterinary Biologics Export Certificates should be emailed to the Pre-market Application Submissions Office (PASO).

Completed Veterinary Biologics Export Certificates carrying the official Canadian Food Inspection Agency (CFIA) stamp will be sent back to the manufacturer by regular postal service unless otherwise instructed by the applicant.

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

The Canadian Centre for Veterinary Biologics (CCVB) reviews applications to import unlicensed products on a case-by-case basis.

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.

An application for a permit to release veterinary biologics (VB) for research or emergency use must include the following documents:

The CCVB may request more information from the manufacturer.

Additionally, the CCVB reserves the authority to inspect permit holders to verify compliance with the Health of Animals Regulations and permit conditions.

Step 3: Apply by email

All documentation as detailed in VB-GL-3.21.1 may be sent by email to the CCVB's general account: cfia.CCVB-CCPBV.acia@inspection.gc.ca.

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised Outline of Production (OP), signed on the last page by an authorized person of the company
  • summary of changes or tracked changes
  • any applicable supporting data and copies of correspondence between the company and the regulatory body

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Outline of Production" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised Outline of Production (OP), bearing the United States Department of Agriculture - Center for Veterinary Biologics (USDA-CVB)'s filed stamp
  • summary of changes or tracked changes, bearing the USDA-CVB's filed stamp
  • any applicable supporting data and copies of correspondence between the company and the USDA-CVB
  • Animal and Plant Health Inspection Service (APHIS) Form 2049: Veterinary Biologics Regulatory E-Submission Form showing the disposition of the USDA-CVB

Each revision to a same Outline of Production should be submitted as a separate application in My CFIA, for invoicing purposes.

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Outline of Production" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised Outline of Production (OP), signed on the last page by an authorized person of the company
  • summary of changes or tracked changes
  • any applicable supporting data and copies of correspondence between the company and the regulatory body
  • any Standard Operating Procedures (SOPs) or equivalent that have been modified in relation to this OP revision

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Outline of Production" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised special outline (SO), signed on the last page by an authorized person of the company
  • summary of changes or tracked changes
  • any applicable supporting data and copies of correspondence between the company and the regulatory body

For special outlines covering materials of animal origins

Special Outlines covering materials of animal origins (MAO) should be:

  1. prepared as an Excel spreadsheet, workbook or equivalent as per VB-GL-3.32
  2. submitted to the Canadian Centre for Veterinary Biologics (CCVB) in an electronic, searchable format to the CCVB Applications email

The MAO SO must be updated yearly.

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Special Outline" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised special outline (SO), bearing the United States Department of Agriculture - Center for Veterinary Biologics (USDA-CVB)'s filed stamp
  • summary of changes or tracked changes, bearing the USDA-CVB's filed stamp
  • Animal and Plant Health Inspection Service (APHIS) Form 2049: Veterinary Biologics Regulatory E-Submission Form showing the disposition of the USDA-CVB
  • any applicable supporting data and copies of correspondence between the company and the USDA-CVB

For special outlines covering materials of animal origins

Special Outlines covering materials of animal origins (MAO) should be:

  1. prepared as an Excel spreadsheet, workbook or equivalent as per VB-GL-3.32
  2. submitted to the Canadian Centre for Veterinary Biologics (CCVB) in an electronic, searchable format to the CCVB Applications email

The MAO SO must be updated yearly.

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Special Outline" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You should compile the following documents into a single PDF file:

  • revised special outline (SO), signed on the last page by an authorized person of the company
  • summary of changes or tracked changes
  • any applicable supporting data and copies of correspondence between the company and the regulatory body

For special outlines covering materials of animal origins

Special Outlines covering materials of animal origins (MAO) should be:

  1. prepared as an Excel spreadsheet, workbook or equivalent as per VB-GL-3.32
  2. submitted to the Canadian Centre for Veterinary Biologics (CCVB) in an electronic, searchable format to the CCVB Applications email

The MAO SO must be updated yearly.

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Special Outline" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

  • Submit all the different label formats (bottle labels, cartons, inserts, etc.) and dose sizes together for approval.
  • Generally, each label should be submitted in a separate PDF file.
    • If the layout and text of the labelling is identical for different product dose sizes, only submit the labelling of the smallest dose size for approval, using that layout and text.
    • All text (panels) associated with a particular label should be contained within the same file.
  • Leave (at a minimum) a 5-cm blank space at the bottom of each page for the approval stamp.
  • Each label file should include the following identifying information on the mounting page:
    • identification of the manufacturer (including the Establishment Licence number, if applicable)
    • product assigned name or trade name
    • Canadian Centre for Veterinary Biologics (CCVB) file number
    • product code, issued by the country of manufacture (if applicable)
    • type of label (container, carton, insert), including dose size
    • date of preparation and/or the version number of that label

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Label Review" service
  5. Follow the instructions to complete your application
    • Comments should be added in the "Summary of changes to labels and reasons for changes" text box
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Approval of manufacturing facility

All veterinary biologics (VB) intended for distribution and use in Canada, or for export to other countries, must be manufactured in a facility approved by the Canadian Centre for Veterinary Biologics (CCVB).

The approval of a new VB manufacturing facility involves:

  • a review of the facility, personnel, manufacturing and quality control/quality assurance documents
  • a pre-licensing inspection of all premises where manufacturing, testing, preservation, packaging, labelling, storage and distribution of VB are performed

Companies intending to design and build VB manufacturing facilities should contact the CCVB early in the facility design process. If your company does not yet have a licensed facility in Canada, then an application can be made at the same time as the product licensing submission.

Refer to the following guidance for more information:

Step 2: Consider a pre-submission consultation meeting

The Canadian veterinary biologics regulations and/or guidance may be modified or updated periodically to reflect changes in technical standards or developments in the international harmonization of regulatory requirements for veterinary biologics.

Before preparing a new product submission, we encourage Canadian VB manufacturers to consult the following guidance to help them determine whether they'll need a pre-submission meeting or teleconference with the CCVB or not:

Prospective new Canadian VB manufacturers should engage the CCVB in discussions early in the facility and VB product design process.

Step 3: Prepare your licensing submission

The process for licensing a new veterinary biologic that is manufactured in Canada has several steps, each of which must be approved by the CCVB before a Canadian VB manufacturer can proceed further with the licensing process.

For specific details on preparing a licensing dossier for veterinary biologics manufactured in Canada refer to:

Producing autogenous veterinary biologics

Veterinary biologics manufacturers in Canada and the United States (U.S.) must get a licence and written approval from the CCVB to produce autogenous VB.

Once an autogenous veterinary biologic is licensed, several criteria apply that differ from fully-licensed VB.

Refer to Autogenous veterinary biologics (VB-GL-3.13) (opens in new window) for specific details on the preparation of a licensing dossier for autogenous veterinary biologics.

Step 4: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Product Licensing (Registration) Submissions" service
  5. Follow the instructions to complete your application
    • The CCVB can modify each of the "Product Information" categories during review
    • We recommend that you have all your documents and files ready when you apply, but if not, select "Save and return later" at any time to avoid losing your progress
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Approval of manufacturing facility

All veterinary biologics (VB) intended for importation from the United States (U.S.) into Canada must be manufactured in a facility licensed and inspected by the United States Department of Agriculture-Center for Veterinary Biologics (USDA-CVB).

The approval of a new VB facility by the Canadian Centre for Veterinary Biologics (CCVB) involve a review of the:

  • facility
  • personnel
  • manufacturing
  • quality control/quality assurance documents

The CCVB may periodically inspect these facilities.

Refer to the following guidance for more information:

Step 2: Complete the licensing process in the United States

A new product submission (NPS) should be submitted to the CCVB after the licensing process is complete in the U.S.

All documents pertaining to product licensing must be submitted at the same time.

Under certain special circumstances, a NPS may be considered for evaluation by the CCVB before final licensing in the U.S. if the VB product is novel to Canada and addresses an emerging and priority need for a VB to manage an infectious disease situation.

Contact the CCVB (opens in new window) for more details and to determine eligibility.

Step 3: Prepare your licensing submission

For specific details on preparing a licensing dossier for veterinary biologics manufactured or licensed in the United States refer to:

A VB manufactured and licensed in the U.S. may be licensed in Canada, provided the conditions identified in the VB-GL 3.1.2 are met.

The CCVB does not routinely repeat manufacturer inspections, master seed testing, pre-licensing serial testing or post-licensing serial release that has already been completed by the USDA-CVB.

Official documentation of these activities must be included with the NPS and will be reviewed by the CCVB.

Producing autogenous veterinary biologics

Veterinary biologics manufacturers in Canada and the United States (U.S.) must get a licence and written approval from the CCVB to produce autogenous VB.

Once an autogenous veterinary biologic is licensed, several criteria apply that differ from fully-licensed VB.

Refer to Autogenous veterinary biologics (VB-GL-3.13) (opens in new window) for specific details on the preparation of a licensing dossier for autogenous veterinary biologics.

Step 4: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Product Licensing (Registration) Submissions" service
  5. Follow the instructions to complete your application
    • The CCVB can modify each of the "Product Information" categories during review
    • We recommend that you have all your documents and files ready when you apply, but if not, select "Save and return later" at any time to avoid losing your progress
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Approval of manufacturing facility

All veterinary biologics (VB) intended for importation into Canada must be manufactured in a facility acceptable to the Canadian Centre for Veterinary Biologics (CCVB).

The product must be produced and tested in accordance with generally accepted good manufacturing practices and quality assurance standards.

The CCVB may periodically inspect these facilities.

Refer to the following guidance for more information:

Step 2: Complete the licensing process in the country of manufacture

A new product submission (NPS) should be submitted to the CCVB after the licensing process is complete in the country of manufacture.

All documents pertaining to product licensing must be submitted at the same time.

Under certain special circumstances, a NPS may be considered for evaluation by the CCVB before final licensing in the country of origin if the new VB product is:

  • novel to Canada
  • specifically developed to address an emerging and priority need for which there is no currently licensed VB in Canada
  • manufactured in a Good Manufacturing Practices (GMP) certified facility

Contact the CCVB (opens in new window) for more details and to determine eligibility.

Step 3: Prepare your licensing submission

For specific details on preparing a licensing dossier for veterinary biologics manufactured or licensed in foreign countries other than the United States refer to:

A VB product manufactured in a foreign country other than the United States (U.S.) can be licensed in Canada provided the conditions listed in VB-GL 3.1.3 are met.

The CFIA may conduct a pre-licensing inspection to confirm:

  • facility and quality assurance documentation
  • VB production and testing

Once a VB product is licensed, the VB manufacturer will be subject to periodic inspections, and the VB product to serial or batch release as a condition of importation.

Results of serial or batch tests on final product performed by the manufacturer must be submitted to the CCVB on a Manufacturer's Serial Release Test Report (MSRTR) for evaluation.

The manufacturer must have an establishment licence, manufacturing authorization or equivalent as issued by the regulatory authorities in the country of manufacture.

Refusing to consider licensure or importation

There are several reasons why the CCVB will refuse to consider licensure and/or importation of a VB product in Canada:

  • Products containing components originating from countries where foot-and-mouth disease, African swine fever, African horse sickness, or other diseases foreign to Canada are endemic
  • Products for the prevention or diagnosis of diseases under a CFIA control or eradication program or for use against animal diseases foreign to Canada, such as hog cholera, bluetongue, vesicular stomatitis, or pseudorabies
    • Some exceptions may be granted if deemed in the best interest of the success of the control or eradication program, or to support emergency preparedness by the CFIA
  • Products that may not be in the best interest of, or contrary to, public health control or survey programs
  • Modified live products (MLV) with residual virulence, such as virulent strains of infectious laryngotracheitis virus
  • MLV products with a known risk of the vaccine strain reverting to virulence under field conditions, such as porcine reproductive and respiratory syndrome virus MLV vaccines
  • Products which were previously imported into Canada and for various reasons (for example, pharmacovigilance concerns; product no longer relevant to infectious animal disease conditions) are no longer considered suitable for use in Canada

Step 4: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Product Licensing (Registration) Submissions" service
  5. Follow the instructions to complete your application
    • The CCVB can modify each of the "Product Information" categories during review
    • We recommend that you have all your documents and files ready when you apply, but if not, select "Save and return later" at any time to avoid losing your progress
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Step 1: Know the timelines

Veterinary biologics product licences expire on May 31 every year for Canadian manufacturers, and June 30 for international manufacturers.

Foreign manufacturers should note that product licence applications must be submitted before or at the same time as import permit applications for the corresponding products.

Step 2: Read the guidance

For specific details and requirements, please refer to:

Step 3: Apply online

For all manufacturers applying to renew a product licence in My CFIA :

  1. Sign in to My CFIA
  2. Select the validated party profile that has the permission you wish to renew
  3. Scroll to the "Service Request" tab and select the "Renew a Permission" button
  4. Select the permission number you wish to renew in the permission table
  5. Select the "Renew" button
  6. Follow the instructions and attach any required documents (as needed)
  7. Enter any details of your requested changes (as applicable)
  8. Submit your application and complete your payment in My CFIA (opens in new window) at least 2 weeks before your permit or licence expires

Continue to My CFIA (opens in new window)

Step 1: Know the timelines

Veterinary biologics establishment licences expire on May 31 each year for Canadian manufacturers.

Step 2: Read the guidance

For specific details and requirements, please refer to:

Step 3: Get your information ready

Canadian manufacturers must:

Step 4: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile that has the permission you wish to renew
  3. Scroll to the "Service Request" tab and select the "Renew a Permission" button
  4. Select the permission number you wish to renew in the permission table
  5. Select the "Renew" or "Renew with Changes" button (as applicable)
  6. Follow the instructions and upload your completed CFIA/ACIA 5214 form on the "Permission Application - 80% Complete" screen under the first item
  7. Upload a copy of your current establishment licence with changes clearly marked under the second item, "Establishment licence or registration from regulatory authority of the exporting country" (if applicable)
  8. Select "Not submitted" for each remaining document in this section for which you have no changes, and click "Next Step" at the bottom of the page
  9. Enter any details of your requested changes (as applicable)
  10. Submit your application and complete your payment in My CFIA (opens in new window) at least 2 weeks before your permit or licence expires

Continue to My CFIA (opens in new window)

Step 1: Know the timelines

Annual import permits expire on June 30 every year.

Canadian importers should note that product licences for foreign manufacturers must be renewed before import permits for related products can be processed.

Step 2: Read the guidance

For specific details and requirements, please refer to:

Step 3: Apply online

For all manufacturers applying to renew an import permit in My CFIA:

  1. sign in to My CFIA
  2. select the validated party profile that has the permission you wish to renew
  3. scroll to the "Service Request" tab and select the "Renew a Permission" button
  4. select the permission number you wish to renew in the permission table
  5. select the "Renew" or "Renew with Changes" button (as applicable)
  6. follow the instructions and attach any required documents (as needed)
  7. enter any details of your requested changes (as applicable)
  8. submit your application and complete your payment in My CFIA (opens in new window) at least 2 weeks before your permit or licence expires

Continue to My CFIA (opens in new window)

Step 1: Read the guidance

For specific details on the requirements for your submission, please refer to:

Step 2: Get your information ready

You must submit test results to the Canadian Centre for Veterinary Biologics (CCVB) on a pre-approved template of a Manufacturer's serial release test report (opens in new window).

Test references on the test report must cite the approved Outline of Production subsection and referenced procedures, as filed with the CCVB.

Step 3: Apply online

  1. Sign in to My CFIA
  2. Select the validated party profile you want to use to apply for your service
  3. Scroll to the "Service Request" tab and select the "New Service Request" button
  4. Use the filters, keyword search or scroll to select the "Veterinary Biologics Serial Release" service
  5. Follow the instructions to complete your application
  6. Review and submit your application

Continue to My CFIA (opens in new window)

Date modified: