Veterinary Biologics Program Service Standards
(Response Times)

The response times shown below are the response times for processing submissions within the Canadian Centre for Veterinary Biologics (CCVB), starting on the day complete applications are received. CCVB reviews submissions and documents, issues licences and permits and conducts inspections of manufacturers. Veterinary Biologics Operations (VBO) veterinarians conduct inspections, review documents and may monitor trials.

1. Review of a new licensing submission1 change in formulation or change in label claims for a veterinary biologic manufactured in Canada

Review initial submission and prepare response

  • Average response time = 3 months
  • Maximum response time = 4 months

Review supplemental data and prepare response

  • Average response time = 4 weeks
  • Maximum response time = 6 weeks

2. Review of a new licensing submission1 change in formulation or change in label claims for a veterinary biologic manufactured in the United States (U.S.)(review with emphasis on Canadian requirements)

Review initial submission and prepare response

  • Average response time = 3 months
  • Maximum response time = 4 months

Review supplemental data and prepare response

  • Average response time = 4 weeks
  • Maximum response time = 6 weeks

3. Review of a new licensing submission1 change in formulation or change in label claims for a veterinary biologic manufactured in countries other than Canada or the U.S.

Review initial submission and prepare response

  • Average response time = 4 months
  • Maximum response time = 6 months

Review supplemental data and prepare response

  • Average response time = 4 weeks
  • Maximum response time = 6 weeks

4. Testing by a laboratory acceptable to CCVB, for licensing submissions

Each master cell line

  • Response times to be determined at the time of submission for licensing.

Each master seed culture

  • Response times to be determined at the time of submission for licensing.

Each pre-licensing serial tested, to a maximum of three

  • Response times to be determined at the time of submission for licensing.

5. Facility Inspections/Audits2

  • Canadian manufacturers - Annually
  • Canadian importers - Every 3 years
  • U.S. manufacturers of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act - Annually
  • U.S. manufacturers of other veterinary biologics3
  • Non-Canadian, non-U.S. manufacturers - Every 4 years

6. Issuance of Permits, Licences and Export Certificates

Annual import permits4 Product licences4 Establishment licences4 Export certificates, Permits to import veterinary biologics for investigational or emergency use.

  • Average response time = 2 weeks

7. Serial Release

CCVB reviews the documents and may require testing by a laboratory acceptable to CCVB.

If samples are not tested

  • Average response time = 5 working days
  • Maximum response time = 10 working days

If samples are tested

  • Response times to be determined at the time of submission for licensing.

8. Labelling review and approval, for minor changes5

  • Average response time = 2 weeks
  • Maximum response time = 4 weeks

9. Review of advertising material6

  • Average response time = 2 weeks
  • Maximum response time = 4 weeks

10. Review of Protocols for Efficacy/Safety Studies

  • Average response time = 2 months

11. Production Outline, minor revisions5

  • Average response time = 2 weeks
  • Maximum response time = 4 weeks

12. Suspected Adverse Events

  • Average response time = 2 weeks
  • Maximum response time = 4 weeks

1. Licensing submissions must conform with CCVB documentation requirements, as specified in Guideline 3.1: Guideline for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics and in supplemental guidelines. Submissions with major omissions will not be reviewed.

2. CCVB reserves the right to inspect more frequently if necessary.

3. For facilities which are inspected annually and licensed by a recognized equivalent federal agency such as the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA-APHIS), CCVB may inspect when the first product is licensed in Canada. Subsequent inspections will be arranged as necessary. CCVB may request copies of inspection reports from USDA-APHIS.

4. Under the current Health of Animals Regulations, annual permits and licences expire at the end of each fiscal year. If appropriate, these are renewed before the expiry date each year.

5. For major changes see items 1, 2 and 3.

6. Submission of advertising material is not mandatory.