Memorandum 2018-04: Mandatory bilingual labelling of veterinary biologics
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Date: June 4, 2018
To: Manufacturers and importers of veterinary biologics
This memorandum serves to notify manufacturers and importers of veterinary biologics of a recent regulatory amendment affecting veterinary biologic product labelling requirements. The regulatory amendment is published in Canada Gazette, Part II, Volume 152, Number 9.
In brief, the amendment will require the labelling of every veterinary biologic sold, advertised or offered for sale in Canada to be bilingual English/French. Additional languages may be shown if desired.
For most products, the vial label, carton label and package insert will each present information to customers in both English and French. For products with small vial labels, where space is limited, the CCVB may allow the use of English-only or French-only vial labels, provided all information on the vial label is repeated in both English and French on a package insert. The CCVB may also allow the use of a bilingual insert as a substitute for fully bilingual component labels in certain other situations where it is not feasible to require Canadian-specific bilingual labels, such as for minor-use, minor-species products where enforcing this requirement would impact product availability.
The CCVB may authorize designated Canadian importers to conduct certain labelling activities to bring imported products into compliance with the bilingual labelling requirement prior to their sale in Canada. Importers may refer to Veterinary Biologics Guideline 3.3 – Labelling of veterinary biologics for information on applying to the CCVB to add or replace package inserts.
Unlicensed veterinary biologics needed for research or emergency use are exempt from the bilingual labelling requirement. Licensed autogenous vaccines must have bilingual English/French labelling.
The updated Health of Animals Regulations requiring bilingual veterinary biologic product labelling will come into force on April 23, 2020. Manufacturers and importers needing to update their labels to conform to the new language requirement should submit their proposed bilingual labels to the CCVB well before this deadline. All product inventory offered for sale in Canada as of April 23, 2020 will have to carry the approved bilingual labelling.
Please contact the CCVB if you have any questions about this memorandum.
Surinder Saini, DVM, MVSc, PhD
Canadian Centre for Veterinary Biologics
Animal Import/Export Division
Animal Health Directorate
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