VB-GL-3.1.3: Preparation of new product licensing (registration) submissions for veterinary biologics manufactured in foreign countries other than the United States

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1. Introduction

The purpose of this guideline is to provide information to foreign veterinary biologics (VB) manufacturers outside of the United States (U.S.) regarding the preparation and submission of documents for the licensing (registration) of VB in Canada. The Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA) is responsible for licensing VB, including veterinary vaccines, colostrum, antibody products and test kits for the diagnosis of infectious diseases, manufactured and/or distributed in Canada under the legal authority of the Health of Animals Act and the Health of Animals Regulations.

The related new product submission checklist, as well as the appropriate veterinary biologics guidelines, should be consulted when preparing a new product submission (NPS) for licensing a VB in Canada.

The CFIA is subject to Canadian legislation, including the Access to Information Act and the Privacy Act, as well as administrative procedures and court orders. The CFIA will treat all information received from foreign VB manufacturers and Canadian VB importers, including confidential proprietary business information, in accordance with such legislation, administrative procedures and court orders.

A NPS should be submitted to the CCVB after the licensing process is complete in the country of manufacture. All documents pertinent to product licensing must be submitted at the same time. All documents, including study reports, the Outline of Production (OP), special outlines (SO) and labels must be reviewed and approved by the CCVB prior to the product licensing.

Under certain special circumstances, a NPS may be considered for evaluation by the CCVB prior to final licensing in the country of origin if the new VB product is novel to Canada, is specifically developed to address an emerging and priority need for which there is no currently licensed VB in Canada, and is manufactured in a GMP certified facility. Contact the CCVB for more details and to determine product eligibility.

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. Foreign VB manufacturers and Canadian VB importers are, therefore, encouraged to consult VB-GL-3.4: Pre-submission consultation meetings and advance notification of new product licensing submissions prior to preparing a NPS, to assist in determining whether or not a pre-submission meeting or teleconference with the CCVB will be necessary.

1.1 Legal authority

2. Definitions

Licensing (or registration)
means regulatory approval from the CCVB to manufacture, distribute and/or sell VB in Canada.
Veterinary biologic (section 2, Health of Animals Act)

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 helminth, protozoa or micro-organism
  • a substance or mixture of substances derived from animals, helminths, protozoa, micro-organisms or plants, or
  • a substance of synthetic origin

VB include vaccines, bacterins, bacterin-toxoids, autogenous vaccines, colostrum, antibody products, immunomodulators, allergenic extracts, and test kits for the diagnosis of infectious diseases in animals.

3. General guidance

3.1 Criteria for VB product acceptability

  • The product must be pure, safe, potent and efficacious
  • The product must be licensed by, or have the approval of, the regulatory authorities in the country of manufacture
  • Each biologically active component must be relevant to infectious animal disease conditions and animal genetics in Canada
  • The product must be manufactured in a facility acceptable to the CCVB
  • The product must be produced and tested in accordance with generally accepted good manufacturing practices and quality assurance standards

3.2 Reasons to refuse 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

3.3 General considerations concerning a new VB product submission

  • The CCVB accepts new VB product submissions in an electronic format
    • The applicant may also submit a licensing application through a file hosting service by advance arrangement with the CCVB
    • The applicant may also mail in the licensing submission on a USB memory device or on DVD, accompanied by a printed cover letter
  • New product submissions for imported products must be complete, and when applicable, regulatory approval must have been received in the country of manufacture, before the NPS will be considered for evaluation
  • A completed new product submission checklist specific for the type of product must accompany each NPS; refer to the Appendix for the appropriate checklist
  • For foreign VB manufacturers, the CCVB will accept new product submissions in either the Canadian format for organization of documents or in the dossier submission format used in the country of origin, provided that a stand-alone Outline of Production document is prepared in the Canadian format
  • A detailed index of submission contents must list all documents by title, file name, version and date (yyyymmdd)
  • Each NPS must include a brief justification for use of the veterinary biologic in Canada, supported by scientific references and/or opinions expressed by professional associations, or a written statement prepared by the manufacturer
    • Rationales should be submitted on company letterhead, dated and signed by the person preparing the rationale
  • All required documents for the NPS should be arranged using the new product submission checklist as guidance and in the order listed on the index of submission contents
    • For electronic submissions, a folder structure corresponding to section dividers (tabs) may be set up
      • Document file names should clearly specify the contents, for example, report, protocol, correspondence, amendment, safety, etc.
      • If multiple documents are compiled into one PDF file, then each document should be bookmarked and identified accordingly
  • Files of breakout products (for example, various combinations of multivalent vaccines) should be submitted at the same time in order that they may be evaluated concurrently if possible
    • All documents, protocols, reports and correspondence must be submitted in English or in French
  • If the original documents are written in a language other than English or French, a certified translation is required
  • Proposed draft labelling material must be bilingual (English and French).
  • Various restrictions and conditions may be applied once licensing is complete; these restrictions and conditions will be listed on the veterinary biologics product licence and on the veterinary biologics import permit, and explained in supplemental correspondence as required

3.4 Submission requirements

Products manufactured and licensed in foreign countries other than the U.S.

A VB product manufactured in a foreign country other than the U.S. can be licensed in Canada provided the conditions listed in section 3 above are met. The CFIA may conduct a pre-licensing inspection to confirm facility and quality assurance documentation and 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.

Special circumstances

Other situations not mentioned above will be evaluated on a case-by-case basis. The CCVB should be contacted for more details.

4. Required forms and licences

5. Facility and personnel requirements

All VB intended for importation into Canada must be manufactured in a facility licensed and inspected by the regulatory authorities of the country of manufacture. This facility must also be acceptable to the CCVB. The approval of a new VB manufacturing facility involves a review of the facility, personnel, manufacturing and quality control/quality assurance documents, and may require a pre-licensing inspection of all premises where manufacturing, testing, preservation, packaging, labelling, storage and distribution of VB are performed.

Consult VB-GL-3.34: Requirements for veterinary biologics facilities.

Consult VB-GL-3.28: Requirements for personnel involved in the manufacturing, testing, and importation of veterinary biologics for a list of required documents related to personnel.

6. Manufacturing and testing protocols

6.1 General considerations

Manufacturers from foreign countries must prepare and submit a copy of the relevant Outline of Production (OP) for the VB product in the Canadian format. Refer to VB-GL-3.7: Guideline for preparation of Outlines of Production, special outlines and summary of changes for veterinary biologics for more details. The OP may cite internationally accepted references such as parts 101 to 123 of the United States Department of Agriculture's Title 9 Code of Federal Regulations (9 CFR), the European Pharmacopoeia (Ph. Eur.) or the World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (2022). Referenced special outlines (SO) may be prepared in the Canadian format or submitted as standard operating procedures (SOP) in the manufacturer's internal format. Once the OP and SO are approved and digitally stamped as satisfactory, a copy of each will be returned to the manufacturer.

Additional confirmatory testing by a laboratory acceptable to CCVB may be required.

6.2 Bulk products and products for further manufacture

For VB formulated from bulk vaccine manufactured at another facility, the manufacturer should also provide a flow chart indicating the source(s) of all antigens and/or components. The manufacturer submitting the NPS is responsible for ensuring that all up-to-date and relevant OP and SO are received by the CCVB from the manufacturer(s) of the bulk component(s).

6.3 Master seeds and master cell stocks

Data must be provided to support identity, purity, safety and stability of the master seed and master cell stocks. The following information is required:

  • Master cell stock data: Identity (species, cell type) karyology, freedom from extraneous agents, tumorigenicity
  • Master seed data: Identity (genus, species, biotype), purity, back passage studies of modified live vaccines
  • Data on the genetic characterization, genetic and phenotypic stability if the product is biotechnology-derived

More information on specific requirements for master seeds and master cells can be found in VB-GL-3.22: Master seed stocks, master cell stocks and serial requirements. More information on specific requirements for master seed and master cells derived from biotechnology can be found in VB-GL-3.2: Regulation of biotechnology-derived veterinary biologics.

A complete list of all micro-organisms handled in the same facilities where the VB will be prepared must be submitted to the CCVB.

Manufacturers handling pathogens foreign to Canada must provide the CCVB with information regarding the identity and handling of these pathogens. The CCVB will conduct a risk assessment to evaluate the risk of cross-contaminating VB manufactured in the same facility.

6.4 Materials of animal origin documentation

In order to protect the Canadian public and the Canadian animal herd from transmissible spongiform encephalopathies (TSEs) and from other infectious animal diseases foreign to Canada, all materials of animal origin used in the production of VB must be sourced from countries and animals acceptable to the CCVB.

More information on specific requirements can be found in VB-GL-3.32: Minimising the risk of introducing transmissible spongiform encephalopathy prions and other infectious agents through veterinary biologics.

7. Labelling

Draft Canadian labels should accompany each NPS. Labels include vial labels, cartons, package inserts and all other printed information distributed with the product.

Labelling must be presented in English and French. A third language may not appear on the labels unless all information is already included in English and French.

More information on specific requirements can be found in VB-GL-3.3: Labelling of veterinary biologics.

 8. Supporting data

Data must be provided to support the purity, potency, safety and efficacy of the VB and to support label claims. Please refer to the appropriate new product submission checklist when collecting this data.

Studies supporting efficacy and safety must be conducted with serials equivalent to the final VB described in the submitted OP. Depending on the specific VB, an efficacy and/or field safety study conducted in Canada may be required by the CCVB. All reports must be dated and signed by the study investigator and by the quality assurance personnel of the manufacturer; each page of the report must be numbered. All study deviations must be attached to the report; the implication of the deviation on the final study outcome must be explained. Assays to measure study outcomes must be carried out according to validated methodologies. Results must be statistically sound and the statistical methodology explained. A copy of each pertinent reprint (scientific publication) is required if it is referred to in the report. Individual animal data for all the animals used in the studies are required; however, these data can be presented in summary tables. Figures, tables and graphs produced in colour must be submitted in colour. Please review the NPS for accuracy and completeness before submitting it to the CCVB.

Any later amendments, including additions and corrections, to a signed and dated research report should be prepared as new, signed and dated documents detailing the changes and referencing the original report.

All correspondence between the manufacturer and the regulatory authorities of the country of manufacture pertaining to the approval of data and studies submitted to support the NPS must be submitted to the CCVB along with the NPS.

9. Summary test results

9.1 General requirements

Manufacturers must submit batch protocols from three consecutive pre-licensing serials to verify uniformity, and serial-to-serial consistency of production serials. These data demonstrate the manufacturer's ability to consistently manufacture serials that meet OP specifications. Upon CCVB request, samples of these serials must be submitted to a laboratory acceptable to CCVB for confirmatory testing.

The test results must be submitted to CCVB on a Manufacturer's Serial Release Test Report (MSRTR). Test references on serial release test result forms must cite the current OP and SO as filed with the CCVB.

Post-licensing serial release testing by a laboratory acceptable to CCVB may be required. All serials must be released by the CCVB prior to distribution in Canada.

9.2 Live vaccines

Live vaccines may require additional testing. These requirements will be evaluated on a case-by-case basis.

9.3 Test kits for disease control programs

Before distribution to the CFIA accredited laboratories only, representative CFIA reference laboratories will test all serials of diagnostic test kits used in the delivery of disease control programs for reportable diseases.

10. Environmental assessment and risk evaluation

The manufacturer is required to present an evaluation of the environmental impact of any novel or biotechnology-derived product.

The CFIA may also prepare a risk assessment, alone or in consultation with other governmental organizations, especially if the micro-organism could be harmful to humans, any animal species or the environment.

11. Importation

The issuance of an annual import permit, or the addition of a product to an existing import permit, corresponds to the licensing of the VB in Canada.

11.1 Designated importer

A Canadian VB importer must be designated by the foreign manufacturer (Form CFIA/ACIA 1503), and approved by CCVB before an import permit will be issued. The facilities of designated Canadian VB importers are inspected prior to the issuance of the import permit and periodically thereafter by the Veterinary Biologics Operations (VBO) group.

11.2 Import permit

  • An annual permit to import veterinary biologics is issued for the majority of VB which have been found acceptable for importation
  • This permit is valid for up to one year and must be renewed every year before June 30
  • Manufacturers should complete an annual review of all licensed VB product files and update required OP, SO and MSRTR templates with the CCVB before submitting an application to CCVB to renew their annual import permit

11.3 Canada Border Services Agency invoice

A copy of this invoice must be kept on record by the designated importer for all VB imported into Canada (on single entry or annual permit). This information may be requested on occasion. It is used for summary statistics only, and is kept strictly confidential.

12. Appendices

The following documents constitute part of this guideline and are appended. The appropriate document is sent to the CCVB along with a submission for the licensing of a new VB.

Product submission checklists

Veterinary biologics template

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