Memorandum 2017-04: Submission of French-language Product Compilation Summaries for Posting on the USDA website

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

Background

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. This information is presented on the website in the form of a Product Compilation Summary (PCS) for each product. At the request of the Canadian Centre for Veterinary Biologics (CCVB), the USDA-CVB has agreed to post the French version of each PCS on the website. This arrangement offers US manufacturers and Canadian importers of US veterinary biologics a simplified, consistent manner to make the referenced study data available to the public in both English and French.

The purpose of this memorandum is to describe the process by which a company can submit French versions of the PCS through the CCVB for posting on the USDA website. The CCVB will facilitate the posting of the French-language PCS only for products that are licensed in Canada.

Preparation of French-language PCS

Companies will be responsible for having the USDA-posted version of the PCS professionally translated into French, and for generating a French PCS that looks identical in format and content to the English version posted on the USDA's website. It is imperative that the French PCS contain identical information as the English PCS previously approved by the USDA-CVB and posted on the USDA's website. This is the case even if the CCVB has requested Canadian-specific precautionary statements, or other differences, for the labels used in Canada.

Please contact the CCVB, using the email VBsingletier@inspection.gc.ca, to request a French PCS template.

Submission of French-language PCS to the CCVB

Companies must submit the PCS as an editable Microsoft Word file. Submissions should be sent to the CCVB by email to VBsingletier@inspection.gc.ca. Alternatively, the file may be provided on a CD or USB flash drive. Submissions should reference both the USDA Product Code and the corresponding Canadian CCVB file number.

A Canadian importer that is not a subsidiary of the US manufacturer may submit a French-language PCS to the CCVB, provided written agreement from the US manufacturer is concurrently filed with the CCVB.

There will be no cost recovery fee for review of the French-language PCS.

The CCVB will review the French PCS for accuracy of the translation. The CCVB will make minor corrections, if necessary, and will share a copy of the final French PCS with the submitting company. If a PCS is received, and the translation is not of high quality, or the format is not identical to the USDA posted version, the CCVB will simply return the PCS to the company as unacceptable.

The CCVB will submit the final, approved French-language data summaries directly to the USDA-CVB for posting on the USDA website.

Questions related to the procedure for submitting French-language PCSs may be sent to the CCVB at VBsingletier@inspection.gc.ca.

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

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