Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement

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Download document Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement
Reference number EMA/189939/2018
Status draft: consultation open
First published 2018-04-03
Last updated 2018-04-03
Consultation start date 2018-04-03
Consultation end date 2018-05-15
Email address for submissions adm-gmdp@ema.europa.eu

Summary

The aim of this public consultation is to collect relevant information from stakeholders to help the Good manufacturing practice (GMP)/Good distribution practice (GDP) Inspectors Working Group to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance. This will amend the compilation of community procedures and exchange of information (CoCP).