Memorandum 2012-02: Phased Implementation of a Revised Bilingual Labelling Policy for Veterinary Biologics Intended for Distribution and Use in Canada

59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 613-773-7408
Facsimile: 613-773-7570

Date:
January 16, 2012

To:
Canadian Manufacturers and Importers of Veterinary Biologics

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The purpose of this memorandum is to inform regulated Canadian manufacturers and importers of planned changes to the Canadian Centre for Veterinary Biologics (CCVB) policies for bilingual English-French labelling for veterinary biologics. These changes will require Canadian manufacturers and importers to provide bilingual product information (i.e. assigned name, container size, intended use, dose, route of administration, withdrawal time, precautions, disposal instructions) for all veterinary biologics that are commercially distributed in Canada.

This revised bilingual labelling requirement will apply to all veterinary vaccines, antibody products, and diagnostic test kits that are represented for diagnosis, prevention, or treatment of infectious diseases in animals in Canada.

This revision to the CCVB's labelling standards for veterinary biologics is necessary in order to conform to the Government of Canada's commitment to promote official bilingualism under the Official Languages Act, which requires that regulators ensure that health and safety information for regulated products is available in both official languages. Section 26 states the following:

Every federal institution that regulates persons or organizations with respect to any of their activities that relate to the health, safety or security of members of the public has the duty to ensure, through its regulation of those persons or organizations, wherever it is reasonable to do so in the circumstances, that members of the public can communicate with and obtain available services from those persons or organizations in relation to those activities in both official languages.

Commencing April 1, 2012, new veterinary biologics product submissions presented for licensing and distribution in Canada should feature fully bilingual carton labels, container labels, and package inserts prior to licensing.

Manufacturers and importers should identify all currently licensed products that are marketed in Canada with unilingual labels. A plan to bring these products into compliance with this policy should be developed and submitted to the CCVB for approval before July 1, 2012.

An option of allowing bilingual package inserts to be distributed with currently licensed products bearing English only or French only container and carton labels is available on an interim basis, until March 31, 2013. In most cases, when currently approved unilingual labels are revised, there will be an expectation that bilingual English-French container labels, carton labels, and package inserts will be developed. Requests for an extension of this authorization beyond March 31, 2013, will be considered on a case-by-case basis. Meanwhile, manufacturers and importers may continue using previously approved labels; however, they are encouraged to begin implementing these changes as soon as possible.

For a limited number of cases (e.g. niche or limited-use products, or temporary authorization for newly licensed products), there will be a provision to allow the use of bilingual package inserts to accompany unilingual carton labels and container labels, as an alternative to requiring fully bilingual carton labels, container labels, and package inserts. The CCVB will determine on a case-by-case basis which specific products will qualify, and whether the package inserts will be approved for short-term or long-term use.

In circumstances wherein a veterinary practitioner or veterinary laboratory diagnostician imports a veterinary biologic directly from the foreign manufacturer for restricted use under their supervision, the product may be imported with labels showing only one official language (i.e. English or French). The prospective importers must acknowledge their awareness that the veterinary biologic's labelling is unavailable in both English and French, and that they accept full responsibility for providing appropriate instructions to anyone using the veterinary biologic under their supervision, to ensure its safe handling, administration, and disposal.

Memorandum 2011-03: Information requirements for addition of package inserts at Canadian veterinary biologics importer facilities outlines the CCVB's policies and procedures for the addition of package inserts at regulated importers' facilities. More general information concerning the labelling of veterinary biologics, including a glossary of accepted translations, may be found in Veterinary Biologics Guideline 3.3E: Labelling of Veterinary Biologics.

We trust that the implementation of this policy will facilitate compliance with Canada's official bilingual language policies, and increase the availability of bilingual English-French directions and precautions for veterinary biologics regulated by the CCVB, without unduly adding to the regulatory burden for Canadian veterinary biologics manufacturers and importers.

Please do not hesitate to contact me if you have any questions or concerns about these implementation plans.

Glen Gifford, DVM, MSc
National Manager
Canadian Centre for Veterinary Biologics
Terrestrial Animal Health Division
Animal Health Directorate