Falsified, substandard and unregistered: the WHO definitions
WHO uses three categories for medical products of doubtful quality. Substandard products are authorised but fail quality specifications, unregistered products lack approval for the market where they are found, and falsified products deliberately misrepresent their identity, composition or source.
- WHO defines substandard medical products, also called out of specification, as authorised medical products that fail to meet their quality standards or specifications, or both.1
- WHO defines unregistered or unlicensed medical products as those that have not undergone evaluation or approval by the national or regional regulatory authority for the market in which they are marketed, distributed or used.1
- WHO defines falsified medical products as those that deliberately or fraudulently misrepresent their identity, composition or source.1,2
- WHO says the older term SSFFC, used before these definitions, sometimes confused substandard and falsified products with the protection of intellectual property rights.1
- A falsified product can carry the name of a real company on its packaging. In alerts on falsified products WHO reports what the genuine manufacturer says, for example that it did not manufacture the product or that the batch number is not genuine.3
- WHO estimated in 2017 that 1 in 10 medicines in low- and middle-income countries failed quality control tests, suggesting the products are substandard or falsified.2
Sources
- World Health Organization, Definitions of substandard and falsified (SF) medical products (2026)
- World Health Organization, Substandard and falsified medical products (fact sheet) (3 December 2024)
- World Health Organization, Medical Product Alert N°2/2024: Falsified OZEMPIC (semaglutide) (19 June 2024)