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What Are Counterfeit, Generic and Substandard Medicines?

The definition of a counterfeit medicine is as follows:

A medical product is counterfeit when there is a false representation2 in relation to its identity and / or source. This applies to the product, its container or other packaging or labeling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients / components,5 with wrong ingredients / components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches or quality defects or  on-compliance with Good Manufacturing Practices / Good Distribution Practices in legitimate and medical products should not be confused with counterfeiting.

According to the WHO definition, what makes a medicine counterfeit is the deliberate or intentional (criminal) nature of the mislabelling of a product. Counterfeit medicines represent an enormous public health challenge: they cause harm to patients and sometimes lead to death.

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