Brussels consults on new GMP guidelines

Published: 3-Aug-2013
Manufacturing Regulatory

They have been amended over fake medicines and globalisation concerns


The European Commission has asked for comments on new good manufacturing practice guidelines regarding certifications by a qualified person and batch releases.

The Commission says the guidelines have been changed better to manage the globalisation of the pharmaceutical supply chains, new quality control strategies and increased falsified medicinal product sales.

Pharma companies should comment by 5 November to ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu

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