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Key definitions

The MEDISAFE project deals primarily with the issue of falsified medicines. However, it is important to consider that other types of illegitimate medications which are not necessarily falsified, but have not undergone the required regulatory controls, are also widely trafficked and can pose a serious threat to public health. The passages below explain the internationally recognized definitions related to these unregulated medical products. 

The WHO’s key definitions

For many years, discussions about the definitions of these products, which were complex and which not everyone agreed on, hindered action in the face of this major threat to public health.

As an illustration of this complexity, WHO used the expression “substandard/spurious/falsely-labelled/falsified/counterfeit medical products”. WHO was responsible for revising these definitions so that they would form part of a public health perspective, without taking intellectual property issues into account. Following these deliberations, the Seventieth World Health Assembly, the main governing body of WHO, adopted the following definitions in 2017:

  • Falsified medical products

Medical products that deliberately/fraudulently misrepresent their identity, composition or source.

  • Substandard medical products

Also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or their specifications, or both.

  • Unregistered/unlicensed medical products

Medical products that have not undergone evaluation and/or approval by the national and/or regional regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.

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