Study supporting the report on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU

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:

1. 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 
2. 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.

The Commission had asked an external consultant to conduct a study on the two subjects cited under (a) and (b) above as a basis for the report to the European Parliament and to the Council.