Memorandum 2018-05: Requirements for submission of United States Department of Agriculture (USDA) digitally signed outlines of production and special outlines of veterinary biologics

59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 613-773-7786
Facsimile: 613-773-7115

Date: August 23, 2018

To: US veterinary biologics manufacturers and designated Canadian importers of US veterinary biologics

The purpose of this memorandum is to clarify the Canadian Centre for Veterinary Biologics' (CCVB) requirements for submitting electronically approved and digitally signed Outlines of Production (OPs) and Special Outlines (SOs) of veterinary biologics imported from the US into Canada. For a complete list of submission requirements (including fees, timing, and format), please consult the Veterinary Biologics Guideline 3.7: Guideline for Preparation of Outlines of Production, Special Outlines and Summary of Changes for Veterinary Biologics.

The CFIA does not currently have the capacity to accept electronic submissions. Therefore, the CCVB will continue to only accept paper copies of new and revised Outlines.

Current submission requirements in Guideline (GL) 3.7 and the corresponding required documents in the case of digitally signed US-Outlines
Current document requirements Documents required for digitally signed US-Outlines
Paper copy of Outline showing USDA stamp Paper copy of Outline with a valid digital signature from the USDA
Paper copy of Summary of Changes document showing USDA stamp Paper copy of a Summary of Changes document or an equivalent document or method of identifying all changes to the outline with rationale (e.g., extract of Track Changes).
Paper copy of APHIS 2015 form

Paper copy of APHIS 2049 form - Veterinary Biologics Regulatory E-Submission Form- Policy, Evaluation and Licensing Information

Paper copy of USDA comments form (if any comments were provided)

Paper copy of any pertinent supporting data and correspondence with the USDA Paper copy of any pertinent supporting data and correspondence with the USDA (including electronic communications)
CFIA/ACIA 5212 form CFIA/ACIA 5212 form
CFIA/ACIA 4720 form with fees CFIA/ACIA 4720 form with fees
The Outline and the CFIA/ACIA 4720 form must be submitted printed single-sided. Remaining documents may be submitted printed double-sided. All documents, except the CFIA/ACIA 4720 form, should be submitted printed double-sided.

This and other clarifications to submission processes will gradually be added to the appropriate CCVB Guidelines.

Surinder Saini, DVM, MVSc, PhD
National Manager
Canadian Centre for Veterinary Biologics
Animal Import/Export Division
Animal Health Directorate