In light of the Parliamentary vote on the proposal for a Directive on the prevention of the entry into the supply chain of medicinal products which are falsified.
(first parliamentary reading expected in September 2010)
Avenue des Nerviens
17:30 - 19:30
The phenomenon of counterfeit medicinal products in the European Union has grown in recent years due to the increasing amount of merchandise crossing borders. Counterfeiting methods are becoming more sophisticated, enabling these products to be channeled though the lawful supply chain and posing a serious threat to the patient. The European Union has responded to this challenge by adopting a proposal for a Directive (COM(2008) 668 final) amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source, and submitted to a first parliamentary reading in September 2010.
This briefing, which will offer two different perspectives from the originator and the parallel trade, will present and discuss the major issues of the proposal currently debated within the European Parliament, such as:
- Definitions of 'falsified medicinal products' and 'brokering of medicinal products'
- Production in third countries and grey markets
- Transparency of the supply chain
- Cost of effectiveness of traceability systems
- New requirements for GMP and GDP (good manufacture and distribution practices)
- Consequences for Internet pharmacies and Internet sales
, Director of Brussels office, Bundesverband der Pharmazeutischen Industrie (BPI), Brussels
, Member of the Board of Directors, Kohlpharma, Merzig
Peter Bogaert, Partner, Covington & Burling LLP, Brussels
Florence Hartmann-Vareilles and Kerstin Hötzel, ERA, Trier and Brussels