Article 3 of the Falsified Medicines Directive requires the Commission to present a report to the European Parliament and to the Council on the following:
- a description, where possible including quantitative data, of the trends in the falsification of medicinal products in terms of categories of medicinal products affected, distribution channels including sale at a distance to the public by means of information society services, the Member States concerned, the nature of the falsifications, and the regions of provenance of these products; and
- an evaluation of the contribution of the measures provided for in this Directive regarding the prevention of the entry of falsified medicinal products in the legal supply chain. That evaluation shall in particular assess point (o) of Article 54 and Article 54a of Directive 2001/83/EC as inserted by this Directive.
Key findings:
- The number of falsified medicinal products decreased in the European legal supply chain in recent years: from 24 in 2017 to 3 in 2022.
- Falsified medicines are mainly traded in the illegal supply chain and pertain to expensive and lifestyle medicines.
- All system participants recognize the importance of the verification system and the medicines safety features it introduces in protecting patients from counterfeit drugs in the legal supply chain.
- There is a different level of involvement and supervision of national competent authorities in different countries.