By a document posted May 14, 2010, the Health Products & Food Branch Inspectorate have set out guiding principles of Health Canada’s decision making framework for identifying, assessing and managing health risks to identify the issues of counterfeit health products. In the background of this document it is set out that, while these issues of counterfeit health products is infrequent, the document is intended to focus on potential vulnerabilities into the regulated supply chain which includes manufacturing, packaging, labelling, wholesaling, importation, distribution and sale of health products. Counterfeit health products are described 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 corrected ingredients/components, with the wrong ingredient/components, without active ingredients, with insufficient active ingredients or with misleading packaging or labelling.”
The Inspectorate would consider health products to be counterfeit if they are unapproved and fraudulently labelled with respect to identity, composition, origins and/or source, have falsifications which may look genuine or forgeries, i.e. printed. It is known that typically counterfeit products are illegal products which are packaged or marked to indicate they have been legally manufactured by the market authorization holder. It is noted that “diverted products” may be considered counterfeit, if proven to be so. A diverted product is a genuine product manufactured by an authorized manufacturer which ends up on a different market than intended, one for which they are not specifically authorized. Examples include: theft of expired or recalled product, illegal redirection of prescription drugs from legitimate sources.
The policy is noted to cover topics such as policy for compliance, verification and enforcement as required. The Inspectorate also plans to educate the public, health professionals and members of the supply chain of the risks of counterfeit products.
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