EU GMP inspections would be conducted by reps from two or more member states.
This article was originally published in The Tan Sheet
Executive Summary
EUROPEAN COMMUNITY GMP INSPECTION SYSTEM WOULD BE DECENTRALIZED, coordinated by the European Medicines Evaluations Agency, but staffed and implemented by the EU member states, European Commission Directorate-General III Pharmaceuticals Unit Head Patrick Deboyser said at a conference in Budapest, Hungary Oct 8. A forthcoming commission proposal on inspections would create a system whereby the inspection of a manufacturing facility by officials from two or more EU member states may be considered "on behalf of the community."
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