New EMEA Concept Paper on the Revision of the EU Guideline Good Distribution Practices (GDP)

As a reaction to the ongoing development of the situation and complexity of drug distribution, the EMEA has made plans for adaptations to the Good Distribution Practice Guideline (94/C 63/03). Among other things, this document is meant to be adapted to the proposals for amending Directive 2001/83/EC regarding the combat against counterfeit medicinal products and to the EC Pharmaceutical Package. Now a concept paper has been published on this topic. The deadline for commenting on the proposals is 31 May 2009.

It is intended to work on two levels. On one level, documents and standards of the WGEO (Working Group of Enforcement Officers) and of other European associations will be identified and revised. On a second level, GDP-relevant authorisation formats, certificates and reference standards are meant to be developed.

You can find the paper at:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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