Memorandum 2017-03: Accommodation of US single-tier labels

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

Date: December 7, 2017

To: US Manufacturers and Canadian importers of US veterinary biologics licensed in Canada

The purpose of this memorandum is to update stakeholders on the Canadian Centre for Veterinary Biologics' (CCVB) plan for accommodating the newly implemented US single-tier label initiative. Effective October 31, 2016, the United States Department of Agriculture (USDA)-Center for Veterinary Biologics (CVB) implemented new labelling rules for products manufactured in the US. The new rules simplify the efficacy claims on vaccine labels to a 'single-tier' statement, and require labels to direct users to a USDA website for animal safety and efficacy data. In the US all newly licensed products will carry the single-tier labels and legacy products will be transitioned over a period of years. The CCVB wants to accommodate these new single-tier labels and ensure the information is available to Canadians in both English and French.

At the request of the CCVB, the USDA-CVB has agreed to post the French versions of the data summaries on the USDA website. Directions to the specific USDA website will be provided on the Canadian labels in both English and French. This arrangement to post the French versions of the data summaries on the USDA website offers manufacturers and importers of US products a simplified, consistent manner to make the study data available in both languages.

Newly licensed US products in Canada will be expected to carry the US single-tier label. French translations of the data summaries should be submitted with Canadian licensing applications. For some particular products, as in the past, a Canadian-specific statement may be required on the labels used in Canada. This would be discussed at the time of licensing of such products in Canada. Legacy US products can be accommodated as they are transitioned to single-tier labels in the US. It is anticipated that the transition period will be years, and a lag period is expected in Canada.

More information on the procedure for submitting French versions of the PCS to the CCVB for posting on the USDA-CVB's website are provided in Memorandum 2017-04.

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