IPEC e-newsletter - Excipients Insight April/May 2018 - 15-05-18


Inside this issue


EMA opens consultation on GMP non-compliance statement

The European Medicines Agency (EMA) is launching a public consultation concerning the EU template for GMP non-compliance statement.

It says the purpose of this consultation is to "collect relevant information from stakeholders to help the GMP/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 amending the Compilation of Community Procedures on Inspections and Exchange of Information (CoCP)." The document is available by clicking here.

Comments on the proposed updated template (pages 3 and 4 of the document) should be submitted no later than 15 May 2018 by email to ADM-GMDP@ema.europa.eu.




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