Falsified Medicinal Product (FMP): A drug product that deliberately deviates from its approved specifications.
Falsified medicines may:
- contain ingredients (including excipients) of low quality or in the wrong doses;
- be deliberately and fraudulently mislabelled with respect to their identity or source, country of manufacturing or its marketing authorization holder ;
- have fake packaging, fake labelling, the wrong ingredients, or low levels of the active ingredients;
- Have a false representation of its history, including the records and documents relating to the distribution channels used.
Falsified medicines do not pass through the usual evaluation of quality, safety and efficacy that is required by national authorisation procedures. Because of this, FMPs pose a significant health risk.
Falsified vs. counterfeit medicines
Falsified medicines are not the same as counterfeit medicines:
- Falsified medicinesare fake medicines that are designed to mimic real medicines.
- Counterfeit medicinesare medicines that do not comply with intellectual-property rights or that infringe trademark law.
