03/02 Eudratrack: Authorization of Medicinal Products in Europe Joint Press Release of BfArM and DIMDI
Press release 02/2003
Since December 2002 the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn and the German Institute for Medical Documentation and Information (DIMDI) in Cologne are the European system operators for the decentralized authorization of medicinal products. Within only six months we have taken over the handling procedures with presently 200 users in 16 nations. BfArM is the German licensing agency responsible for the professional support; DIMDI guarantees the technical implementation.
A drug can obtain marketing authorization for all EU member states in the course of the centralised European licensing procedure. In addition, there has been a full electronic system for the development of decentralised and selective marketing authorizations for medicinal products in EU countries since 1997.
In the so-called Mutual Recognition Procedure (MRP) with Eudratrack, one Reference Member State (RMS) is in charge of initiating a licensing procedure within 60 days in which the other Concerned Member States (CMS) obtain specific licensing data and can then issue a marketing authorization for a medicinal product in a procedure of mutual recognition.
All EU Member States, as well as Norway and Iceland, are connected to the Eudratrack system. We estimate that the licensing agencies of the future members of the EU will also take part in this procedure within the scope of the EU-enlargement starting May 2004 at the latest.
The Eudratrack software is the technical basis of the authorization procedure that was researched and developed by a research facility of the EU on behalf of the EU-Commission. Eudratrack should have been operated by the European licensing agencies as a production system starting 2003. However, takeover by commercial bidders failed due to the very high costs. Finally, in collaboration with DIMDI, BfArM submitted an offer for the operation that was accepted unanimously by the European licensing agencies.
This cooperation of various parties throughout Europe, with the support of the Danish authorities during the EU-Presidency of Denmark whose representative spoke of "a historical decision in the collaboration of licensing agencies", is indeed a milestone: Within only six months the basic technical, legal and organizational conditions were implemented so that Eudratrack could go into operation at DIMDI on December 16, 2002 - without interrupting the work of the networked licensing agencies. The system will be run and further developed by BfArM and DIMDI until at least 2005.
Year of issue: 2003