14.07.2010
17:30 - 19:30

Counterfeiting Of Medicinal Products In The European Union

Academy of European Law (ERA)
Metzer Allee 4
D-54295 Trier
Phone: +49 (0)651 93 7370
Fax: +49 (0)651 93 7379
Email: info@era.int

Link to the organizer
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Conference / Convention

Health

Registration required, Entrance fee

Executive Briefing Center
85, Avenue des Nerviens
B - 1040 Brussels

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

* Impact on parallel trade

Alexander Natz, Director of Brussels‘ office, Bundesverband der Pharmazeutischen Industrie (BPI), Brussels; Thilo Bauroth, Member of Directors, Kohlpharma, Merzig.