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GMP News
21/04/2010
 

Germany's Preparations for the Traceability of Medicines

  

In February 2010 Aegate announced that a programme was to be started in conjunction with the National Union of German Pharmacists Associations (ABDA) to evaluate the impact and possible advantages of an authentification system in Germany. The Federal Association of the Pharmaceutical Industry (BPI) is also represented in this project. It was essential to the associations that a new established system could co-exist with the already established drawback system, along with straightforward equipment for pharmacies. The pilot project is to be adapted over seven months and numerous pharmacies throughout Germany, with pharmaceutical companies and wholesalers being incorporated and, as in Sweden and Turkey, use made of the 2D Data Matrix Code as an information carrier.

Germany joins Italy, Sweden, France, Greece, Belgium and Italy, as countries which are endeavouring to, or have already introduced, a central data base system for the traceability of medicines. In Germany this is quite clearly the result of the guideline drawn up by the EU Commission from 2008 to combat counterfeit medicines. The adoption of this directive is still expected for the first half of 2010.

The original announcement from Aegate can be found here, and the ABDA press release is available in German here.

The Managing Director of Aegate will be talking at the 2nd ECA Conference on Tracking & Tracing (16/17 June 2010 in Stockholm) about the requirements for a harmonised European system.

Author:
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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