Anti-counterfeiting of medicinal products (Directive)

The analysed Proposal for a Directive is part of the Pharmaceutical Package to improve the safety of medicinal products. The Proposal focuses on the protection of distribution chains from manufacturers to pharmacies against the entry of falsified medicinal products. During debates held previous to the Proposal the Commission opted for maintaining parallel import trade. To this end, the measures proposed now are restricted to prescription medicines, which constitute the majority of medicinal products traded through parallel import.


The Commission succeeds in improving safety and, at the same time, maintaining parallel import trade. However, it fails to address the problem of falsified medicinal products traded through the internet. So there is a backlog of measures to be taken.