Memorandum 2013-03: Bilingual labelling of veterinary biologics

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

Date:
July 18, 2013

To:
Manufacturers and designated Canadian importers of veterinary biologics

Subject:
Bilingual labelling of veterinary biologics

The purpose of this memorandum is to clarify the language requirements for the labels of veterinary biologics imported into or sold, advertised, or offered for sale in Canada.

This memorandum supersedes all previous Veterinary Biologics Memoranda related to labelling. Please consult the revised Veterinary Biologics Guideline 3.3: Labelling of Veterinary Biologics for more information on the preparation and submission of veterinary biologics labels.

The current regulatory authority related to the language requirements for the labels of veterinary biologics imported into or sold, advertised, or offered for sale in Canada is Subsection 134.(3) of the Health of Animals Regulations:

The information contained on the label of a veterinary biologic imported into or sold, advertised or offered for sale in Canada shall be shown in its entirety in either or both official languages and, if both official languages are shown, may additionally be shown in whole or in part in any other language.

In accordance with the CFIA's responsibility to ensure that information related to health and safety is available to Canadians in their official language of choice, the Canadian Centre for Veterinary Biologics (CCVB) will continue to recommend the use of bilingual labels for veterinary biologics imported into or sold, advertised, or offered for sale in Canada. However, unilingual English or French labels that meet the current requirements of the Health of Animals Regulations will be accepted by the CCVB. Currently approved unilingual labels will continue to be valid.

The CCVB intends to amend Subsection 134.(3) of the Health of Animals Regulations in order to require fully bilingual labeling for veterinary biologics imported into or sold, advertised, or offered for sale in Canada. This amendment is consistent with the CFIA's responsibility to ensure that health and safety information is available to Canadians in their official language of choice.

The current exemptions for unlicensed veterinary biologics imported for research or emergency use will be maintained.

The CCVB will publish updates to this regulatory amendment proposal as they become available. Public consultations will be scheduled as part of the regulatory amendment process.

Glen Gifford, DVM, MSc.
National Manager
Canadian Centre for Veterinary Biologics
Animal Import/Export Division

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