Health Canada Provides Counterfeit Health Products Guidance

Health Canada, the official Canadian governmental regulatory agency charged with the responsibility of the countries public health, has released a guidelines document on the public health issue of the counterfeiting of health products and outlines how the agency intends to identify and manage health risks associated with fakes.

According to Diana Dowhwaithe, Health Canada’s Director General the document is meant "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."

The purpose of the new guidelines document 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 document defines counterfeit medical products as:

"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."

The lone point of contention of the document by Secure Pharma Chain Blog's perspective is the report's minimizing of the potential risk to the Canadian population of counterfeit health care products, which runs counter to most relevant statistics, trends and generally acceptated authorities opinion's of the growing nature of this potentially deadly threat.

Secure Pharma Chain Blog endorses the continued enforcement, guidance and improved focus of all regulatory agencies in dealing with fraudulent, adulterated and counterfeit medications and medical products and encourages all members of the pharmaceutical supply chains to utilize solutions and technologies to protect their inventories and healthcare consumers.

To learn about supply chain solutions to pharmaceutical counterfeiting, visit: www.xstreamsystems.net.

To read the entire document from Health Canada, visit:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/activit/pol_0048_counterfeit-contrefacon_eng.pdf.