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. The Biologics Evaluation Laboratory (BEL) reviews test methods, performs laboratory tests, may review submissions and may conduct some inspections. Veterinary Biologics Operations (VBO) veterinarians conduct inspections, review documents and may monitor trials.

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

CCVB reviews the submission. BEL reviews the test methods.

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 submission,¹ 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)

CCVB reviews the submission.

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 submission,¹ change in formulation or change in label claims for a veterinary biologic manufactured in countries other than Canada or the U.S.

CCVB reviews the submission. BEL reviews the test methods.

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. Laboratory testing² by BEL, for licensing submissions

each master cell line
Average response time = 3 months
Maximum response time = 4 months

each master seed culture
Average response time = 3 months
Maximum response time = 4 months

each pre-licensing serial tested, to a maximum of three
Average response time = 3 months
Maximum response time = 4 months

5. Facility Inspections/Audits³

Inspections may be carried out by CCVB or VBO, and may include BEL.

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 biologics - USDA⁴
Non-Canadian, non-U.S. manufacturers - Every 4 years

6. Issuance of Permits, Licences and Export Certificates
Annual import permits,⁵ Product licences,⁵ Establishment licences,⁵ Export certificates, Permits to import veterinary biologics for investigational or emergency use.

CCVB reviews the submission and issues documents.

Average response time = 2 weeks

7. Serial Release

CCVB reviews the submission. BEL receives samples and may perform tests.

If samples are not tested
Average response time = 5 working days
Maximum response time = 10 working days

If samples are tested
Average response time = 35 working days
Maximum response time = 45 working days

8. Labelling review and approval, for minor changes⁶

CCVB reviews the submission and approves labelling.

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

9. Review of advertising material⁷

CCVB reviews the submission and approves advertisements.

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

10. Review of Protocols for Efficacy/Safety Studies

CCVB reviews the submission. BEL may provide comments.

Average response time = 2 months

11. Production Outline, minor revisions⁶

CCVB reviews the submission. BEL may review the test methods.

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

12. Suspected Adverse Events

CCVB reviews the submission. BEL may provide comments and may conduct tests.

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

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

²Response times are subject to factors such as reagent availability.

³CCVB reserves the right to inspect manufacturers more frequently if necessary.

⁴For 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.

⁵Under 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.

⁶For major changes see items 1, 2 and 3.

⁷Submission of advertising material is not mandatory.