Memorandum 2011-03: Information requirements for addition of package inserts at Canadian veterinary biologics importer facilities

To:
Designated Canadian importers of veterinary biologics

The purpose of this memorandum is to define the information requirements for approval to add or substitute package inserts at Canadian veterinary biologics importer facilities.

Package inserts included with veterinary biologics distributed in Canada are considered part of the package labelling and must conform with sections of the Health of Animals Regulations pertaining to the labelling of veterinary biologics in Canada. In the past, the Canadian Food Inspection Agency (CFIA) – Canadian Centre for Veterinary Biologics (CCVB) regulated this addition or substitution as a “manufacturing” activity. Therefore, some designated Canadian veterinary biologics importers were required to hold both Canadian Veterinary Biologics Establishment and Product Licences in order to add or substitute approved package inserts for imported veterinary biologics. The CCVB has reviewed this requirement and has determined that these activities would be more appropriately and effectively regulated through a Special Outline, rather than through Canadian Veterinary Biologics Establishment and Product Licences for labelling only.

To simplify the process and to reduce the regulatory burden on designated Canadian importers, importers whose sole labelling activity is the addition or substitution of a package insert will no longer be required to hold a Canadian Veterinary Biologics Establishment Licence and a corresponding Canadian Veterinary Biologics Product Licence, provided the addition or substitution of Canadian package inserts is authorized by the CCVB. More complicated re-labelling activities which involve manipulation of the product containers – for example, applying new vial labels, changing cartons, or re-bottling – will continue to require a Canadian Veterinary Biologics Establishment Licence and a corresponding Canadian Veterinary Biologics Product Licence.

Each designated Canadian importer who wishes to add an approved Canadian package insert to a licensed veterinary biologic that they import will be required to develop a Special Outline describing the process. (See below.) An up-to-date version of this Special Outline must be submitted to the CCVB for approval prior to commencing this activity.

To accommodate short-term requirements, the CCVB may also authorize the addition of an approved package insert to some imported veterinary biologics, on a temporary basis. This will be managed on a case-by-case basis. Designated veterinary biologics importers should contact the CCVB for more details.

The package inserts should be bilingual (both English and French). They should not include the foreign manufacturer's veterinary biologics establishment licence number (e.g., U.S. Veterinary Biologics Establishment number) since these inserts will not be submitted to the foreign regulatory agency (e.g., USDA – Center for Veterinary Biologics) for approval. The package inserts should be added to all pertinent product distributed in Canada. They should be mounted and presented as described in Veterinary Biologics Guideline 3.3: Labelling of Veterinary Biologics, available on the CCVB website.

It is also important to note that the addition of an approved package insert to imported veterinary biologics does not exempt veterinary biologics from compliance with subsection 134(3) of the Health of Animals Regulations, which states as follows:

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.

The following is a list of requirements for approval from CCVB to include a Canadian package insert with imported veterinary biologics:

1. The applicant must be an approved designated Canadian importer of veterinary biologics.
2. The veterinary biologic must be licensed for use in Canada, or authorized by the CCVB for restricted use.
3. The importer's facilities where the package inserts are added or substituted must be inspected regularly by a member of the CFIA-Veterinary Biologics Operations or CCVB.
4. The Special Outline describing the process must be reviewed and approved by the CCVB.
5. The package insert must be stamp-approved by the CCVB.
6. The Special Outline must be kept up to date.

The minimum information requirements for the Special Outline are as follows:

1. the location of the designated Canadian importer where the package insert will be added or substituted;
2. the position titles of the importer personnel who are responsible for adding or substituting the insert to the product;
3. detailed steps describing the labelling process (including the time required to complete the process, and the temperature for storage of the product when package inserts are being added or substituted);
4. all quality control steps to verify that the correct insert is included with each product;
5. a description of the product, as follows:
   1. assigned name,
   2. product identification from country of manufacture (e.g. USDA Product Code),
   3. CCVB Product File number, and
   4. manufacturer's identification (e.g. U.S. Veterinary Biologics Establishment License number);
6. submission to CCVB of at least two copies; and
7. the last page of the Special Outline signed by the Regulatory Affairs person responsible for its preparation.

If you have any questions or require additional information about the above requirement, please contact the CCVB at 613-773-7408.

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