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VB-GL-3.13: Autogenous veterinary biologics

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1. Introduction

The purpose of this guideline is to provide information regarding the requirements for manufacturing, importation and distribution (including exportation) of autogenous veterinary biologics for use in terrestrial animals and farmed fish. The Canadian Centre for Veterinary Biologics (CCVB) is responsible for licensing veterinary biologics (VB), including autogenous vaccines, under the legal authority of the Health of Animals Act and the Health of Animals Regulations.

In accordance with the Health of Animals Act Section 64.(1)(s), veterinary biologics (VB) must be shown to be pure, potent, efficacious and safe. However, during an emergency, data to demonstrate potency and efficacy may be exempted under Section 131.1 (1) of the Health of Animals Regulations. Autogenous VB may be approved to meet a specific and immediate need when a disease is associated with a new pathogenic organism, when licensed commercial VB are not effective or not available to prevent or control the disease situation.

Use of infected tissue, blood, serum or faeces from sick or dead animals in healthy animals and use of bedding materials from contaminated premises to other premises is considered unacceptable from a veterinary biosecurity perspective. This practice is in violation of Health of Animals Regulations Part X Sections 112 and 113.1.

Note: This guideline uses terminology for terrestrial animals. In the case of autogenous VB for fish, the reader should substitute the terms hatchery, or fish farm, where appropriate, for the terrestrial references.

1.1 Legal authority

Health of Animals Act

Health of Animals Regulations, Part XI

2. General guidance

2.1 Basic criteria

2.2 Roles and responsibilities of the attending veterinarian

The attending licensed veterinarian will be responsible for:

2.3 Roles and responsibilities of the manufacturer

The Canadian or U.S. manufacturer will be responsible for:

3. Production of autogenous VB

3.1 Facility and personnel requirements

Refer to the following guidance for facility, personnel, and equipment requirements:

3.2 Data and documentation requirements for licensing autogenous VB

Canadian and U.S. autogenous VB manufacturers should refer to the following guidance for preparing an autogenous VB licensing submission:

The following documents are required for an autogenous VB licensing application:

  1. a cover letter introducing the submission and identifying the regulatory contact
  2. Form CFIA/ACIA 4720 – Application for Services and the financial account number of the applicant
  3. Form CFIA/ACIA 1503 - Veterinary biologics information
  4. a signed copy of a generic OP for the autogenous VB that require similar materials and methods for production and testing
    • a separate OP will be required for each autogenous VB, if the production and testing methods differ significantly from the generic OP
  5. a signed copy of each SO (such as test methods for sterility, safety, inactivation, residual formaldehyde, etc.)
  6. information on materials of animal origin used for isolation of seed materials, and production and testing of autogenous VB
  7. Declaration of compliance for materials of animal origin
  8. a copy of a sample manufacturer's serial release test report (MSRTR) (refer to appendix 1)
    • A sample copy of the MSRTR is not required from U.S. manufacturers
  9. adjuvant safety data for autogenous VB formulated with an adjuvant
  10. validation data for product inactivation
  11. draft container labels and package insert

Each application is reviewed on a case-by-case basis. Additional information may be requested by the CCVB at the time of review.

Companies should contact the Pre-market Application Submissions Office (PASO) if they require information about opening a CFIA billing account or to pay by credit card.

3.3 Labelling of autogenous VB

Canadian and U.S. autogenous VB manufacturers must submit a generic label with the initial licensing application. Depending on the size of the final container, some of the information may be included in the package insert. Final container label must present information to customers in both English and French. The CCVB may allow the use of a bilingual insert as a substitute for fully bilingual container label. Refer to VB-GL-3.3: Labelling of veterinary biologics.

The labelling for autogenous VB must contain the information as listed below:

3.4 Additional requirements and restrictions for production and use of autogenous killed viral vaccines

A separate submission is required for each autogenous killed virus vaccine; this will cover all strains of a particular virus type. Each application for an autogenous killed virus vaccine is reviewed on a case-by-case basis in consideration of that virus, its known strains and variants.

In addition to the documents listed above, an application for autogenous killed virus vaccine will include:

3.5 Requirements for importation of autogenous VB from the United States

The approval of autogenous VB manufactured in the U.S. is a 3-step process.

Step 1: The U.S. manufacturer must meet the data and documentation requirements for the manufacturing facility, and materials and methods used in production and testing of autogenous VB. The U.S. manufacturing facility will be inspected by a CFIA veterinary inspector before the approval of the first autogenous VB.

In addition to the requirements listed above, U.S. manufacturers are required to submit the following materials:

CCVB approval of the submitted documentation allows U.S. manufacturers to prepare autogenous VB for attending veterinarians in Canada in accordance with the specific conditions or restrictions identified at the time of the approval.

Step 2: The attending Canadian veterinarian submits the following documents to apply for a permit to import a specific serial of autogenous VB:

Step 3: The U.S. manufacturer submits the following documents directly to the CCVB:

Each request for production and importation of an autogenous VB serial from the U.S. is reviewed on a case-by-case basis. Additional information may be requested by the CCVB at the time of review. Upon approval of the application, a single entry permit to import veterinary biologics will be issued to the attending veterinarian for a specific serial of the autogenous VB. A copy of the permit must be kept on file by the attending veterinarian and a copy of the permit must accompany each shipment.

Canadian veterinarians and U.S. autogenous VB manufacturers should contact the Pre-market Application Submissions Office (PASO) if they require information about opening a CFIA billing account or to pay by credit card.

Autogenous killed virus vaccine

For a serial of an autogenous killed virus vaccine, the attending veterinarian is required to submit forms CFIA/ACIA 4720 and CFIA/ACIA 5569 to the CCVB prior to 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 is required to 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.

3.6 Requirements for production and use of multivalent autogenous VB

Ordinarily, autogenous bacterin or autogenous killed viral vaccines shall be monovalent. However, an autogenous VB containing more than one organism may be prepared and used at the discretion of the attending licensed veterinarian.

Production and use of autogenous VB containing multiple organisms must be justified in writing. An autogenous VB shall contain only the organisms which are isolated from the same herd or flock, and are considered to be the cause of the current disease situation. Since the data to support lack of antigenic interference is not available for autogenous VB, the number of antigenic fractions contained in an autogenous VB must be minimized as much as possible. The risk of adverse reactions due to a multivalent autogenous VB must also be considered.

Separate approval is not required from the CCVB for the production of autogenous bacterin vaccine containing more than one organism. A copy of the written justification from the attending veterinarian must be maintained in the batch file and made available to a CFIA veterinary inspector when requested. The approved OP must describe the materials and methods used in production and testing of all antigens of a multivalent autogenous VB.

Pre-approval from the CCVB is required prior to production of autogenous killed viral vaccines containing more than one organism.

Autogenous VB must not be mixed with licensed products because supporting data to evaluate the impact of the autogenous product on the safety and efficacy of the licensed product is not available.

3.7 Requirements for production and use of autogenous VB in adjacent and non-adjacent premises

Autogenous VB are to be used only on the premises from which the microorganism was isolated. At the discretion of the attending licensed veterinarian, an autogenous VB may be used in adjacent premises if the animals at the adjacent premises are considered to be at risk. Only the isolate from the recent outbreak of infectious disease shall be used.

An autogenous VB may be used at non-adjacent premises only with a valid justification from the attending licensed veterinarian. The veterinarian must clearly identify the common links or sources that could potentially transmit the disease between the herd of origin and the non-adjacent premises.

Separate approval is not required from the CCVB for use of an autogenous VB in adjacent and non-adjacent herds. However, a copy of the written justification from the attending veterinarian must be maintained in the batch file and made available to a CFIA veterinary inspector when requested.

3.8 Requirements for production and use of autogenous VB beyond 36 months

Autogenous VB may be produced from the same isolate up to 36 months without additional data and justification, provided that updated information as specified in  form CFIA/ACIA 5569 Information Required for Prescription Platform Product and Autogenous Veterinary Biologics is on file. The long term use of the same isolate for production and use of an autogenous VB is not considered an emergency under Section 131.1 (1) of the Health of Animals Regulations. Therefore, the use of the same isolate for production of autogenous VB beyond 36 months from the date of its first isolation must be justified. All requests for the use of an isolate beyond 36 months are reviewed by the CCVB on a case-by-case basis.

To approve the same isolate for production of autogenous VB beyond 36 months from the date of isolation and up to 60 months, the attending veterinarian(s) must submit a written request to the CCVB and provide justification for its continuous use. The justification must include but is not limited to the satisfactory performance from the previous use, information on vaccine safety, effectiveness and ongoing diagnosis/surveillance effort.

3.9 Serial release procedure for autogenous VB, including autogenous killed viral vaccines

The required quantity of representative samples from each serial must be collected for testing by the manufacturer and for retention by the manufacturer for independent confirmatory testing as directed by the CCVB.

Each serial of autogenous VB must be tested for sterility, safety, completion of inactivation, residual formaldehyde (if applicable), and any other tests as specified in the approved OP. All required tests must be completed satisfactorily and documented in the MSRTR before releasing the serial for shipment. A satisfactory serial can be released by the quality control or quality assurance supervisor of the manufacturer after verifying its compliance with the requirements.

The CCVB may require manufacturers to submit serial release documents for review, if the new serial is significantly different from the products previously produced by the manufacturer or there is a significant change in the production and/or testing process. After satisfactory review of the documents, the CCVB will authorize the manufacturer to release the serial(s).

3.10 Requirements for production of autogenous VB for export to foreign countries

A new serial of autogenous VB may be prepared by a Canadian manufacturer for export to a foreign country under the existing product licence with the conditions listed below. Requests for production of an autogenous killed virus vaccine for export to foreign countries will be reviewed on a case-by-case basis and the specific requirements will be identified during the review of the application. Written authorization from both the regulatory authority of the importing country and the CCVB must be obtained prior to initiating the production of a new serial of autogenous VB intended for export. The manufacturer will be responsible for complying with the national, provincial and local regulations of the importing country, and any conditions or restrictions specified by the regulatory authority of the importing country

Procedure for obtaining written approval from the CCVB for production and export of autogenous VB to foreign countries

To obtain an approval, the Canadian manufacturer must submit the following documents to the CCVB for review:

After the receipt and satisfactory review of the above documents, the CCVB will authorize in writing the introduction of the seed into the autogenous VB production facility for production of a new serial of autogenous VB. There is no cost recovery fee associated with this service.

3.11 Record keeping

The following records for each serial of autogenous VB must be maintained by the manufacturers and made available to a CFIA veterinary inspector when requested:

3.12 Reporting of autogenous VB production

A summary of all serials of autogenous VB produced, including unsatisfactory serials, must be reported by the manufacturers to the CCVB on a quarterly basis. Foreign manufacturers will only be required to report on those serials of autogenous VB that are manufactured for use in Canada. Quarterly reports should be submitted no later than the last day of January, April, July, and October. Summaries must include the following information:

The summary information must be signed and dated by the authorized representative of the company. An example of the summary information to be submitted is found in Appendix 2. Other formats of summary information are also acceptable.

3.13 Restrictions on advertisement of autogenous VB

The authority for regulating the advertisement of VB is provided in the Health of Animals Regulations, Part XI Section 135. (1) and 135. (2) which require all advertised claims to be supported by data on file with the CCVB. Manufacturers of autogenous VB may advertise their services for the purpose of informing Canadian veterinarians. However, any specific autogenous VB or any claim against specific disease (including potency and efficacy) must not be advertised, due to the lack of data to support potency, field safety and efficacy.

4. Additional information

Contact the CCVB if you have additional questions or need clarification on regulations and requirements for autogenous veterinary biologics.

Guidelines and forms are available on the CCVB website.

5. Appendices

Appendix 1: Sample copy of manufacturer's serial release test report (MSRTR) for an autogenous veterinary biologic

Company name
Canadian veterinary biologics establishment licence number
Telephone - facsimile

Product name:

CCVB file number:
Outline of Production date:
Animal species:
Name and address of the farm:

Serial number:
Unique identification number of isolate:
Fill date:
Expiration date:
Container size (doses or mL):
Total number of containers:
Total number of doses:

Name and address of the attending veterinarian:

Test and reference Date on test yyyy/mm/dd Date off test yyyy/mm/dd Test requirement Table Note 1 Test results Code: Table Note 2
Purity (pre-inactivation)
OP/SO reference
Sterility - bulk product
OP/SO reference
Sterility - finished product
OP/SO reference
Animal safety
OP/SO reference
Residual formaldehyde
OP/SO reference
Other tests (specify)
OP/SO reference

Disposition by manufacturer

All tests completed satisfactory (yes or no):
Eligible for release (yes or no):
Destroyed (if yes, reasons for destruction):
Additional comments (if applicable):

Signature of the laboratory technician:

Date:

Signature of the QA manager:

Date:

Appendix 2: Example of autogenous veterinary biologics summary information

Company name:
Canadian veterinary biologics establishment licence number:
CCVB product file number:

Serial number Microorganism(s) Isolate number Date of serial release Number of containers and total doses Expiry date Name and address of farm Name and address of veterinarian

Name, signature, and date:

Title:

Date modified: