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

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).

Keywords: Good manufacturing practice, GMP, European Union, EU template, non-compliance statement, compilation of community procedures (CoCP), medicine shortage

Current effective version

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

Draft: consultation closed Consultation dates: 03/04/2018 to 16/05/2018 Reference Number: EMA/189939/2018 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).