Definitions of Substandard and Falsified (SF) Medical Products
On 29 May 2017 at the Seventieth World Health Assembly, a decision was agreed to adopt “Substandard and Falsified (SF) medical products” as the term to be used in the name of the Member State mechanism and in all future documentation on the subject of medical products of this type. The approved document on definitions is available at the following link:
WHO has highlighted this definition and terminology change in a news release for the Seventieth World Health Assembly, available at the following link:
The old “substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC)” terminology surfaced from the lack of a global common understanding, sometimes confusing the phenomenon of substandard and falsified products with the protection of intellectual property rights.
Clarity and simplification of the terminology and definitions is an important and critical milestone towards the prevention, detection, and response to SF medical products. To strengthen coordination and collaboration, it is hoped that all other stakeholders engaged on this issue will also adopt these new definitions to permit a more thorough and accurate comparison and analysis of data and other efforts to combat SF medical products.
Substandard: Also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or specifications, or both.
Unregistered/unlicensed: Medical products that have not undergone evaluation and/or approval by the National or Regional Regulatory Authority (NRRA) for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.
Falsified: Medical products that deliberately/fraudulently misrepresent their identity, composition or source.