Canadian regulator publishes counterfeit guidance

Health Canada has finalised a guidance document on counterfeiting of health products, laying out the principles of how the agency intends to identify, assess and manage health risks associated with fakes.

The primary objective of the response strategy is "to manage the risk to Canadians and to have the counterfeit product removed from market using the most appropriate level of intervention and notifying parties at risk," according to Diana Dowthwaite, Health Canada's Director General.

The document - which can be downloaded here - indicates that the presence of counterfeit health products in the regulated supply chain in Canada is "infrequent."

Nevertheless the purpose of the new guideline is to help Health Canada's inspectorate and enforcement officials focus on potential vulnerabilities in health product "manufacturing, packaging/labelling, wholesaling, importation, distribution, sale and use."

The scope of the guidance covers finished medicinal products, raw materials and ingredients used in their manufacture and primary and secondary packaging, as well as advertising materials used to promote products.

It also lays out a detailed definition for counterfeiting, noting that - in general - the term does not cover: diverted products (although these could serve as an indicator of counterfeit distribution); products using patented ingredients/design but which do not mislead or claim to originate from the rights holder; and products which do not disclose all ingredients or have labelling issues.

The full definition runs as follows:

"A counterfeit health product is one that is represented as, and likely to be mistaken for, an authentic product.

Counterfeiting can apply to both branded and generic products, and could relate to a product’s identity or source, could include products with the correct ingredients/components, with the wrong ingredient/components, without active ingredients, with insufficient active ingredients or with misleading packaging or labelling."