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News about GMP/cGMP

2011-11-14

EMA: Revision Annex 16

The European Medicines Agency (EMA) released a concept paper on Annex 16 of the EU GMP Guide.

 

Annex 16 of the Guide to Good Manufacturing Practice for Medicinal Products gives guidance on the certification and batch release of medicinal products within the European Union and European Economic Area.

Outcome:

Draft consultation is open until January 31, 2012. If you have comments or suggestions, send them to ADM-GMDP@ema.europa.eu.

Source:

EMA/ Annex 16

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