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

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Public consultation

Deadline for comments: 15/05/2018

Reference numberEMA/189939/2018
Published03/04/2018
KeywordsGood manufacturing practice, GMP, European Union, EU template, non-compliance statement, compilation of community procedures (CoCP), medicine shortage
DescriptionThe 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).


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