New Guidance for Coordination of GCP Inspections published

Eudralex Volume 10 has been amended with Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures. The document forms part of the guidance documents containing the common provisions on the conduct of GCP inspections.

This guidance document applies only to the coordination of GCP inspections carried out by EU/EEA inspectors in connection with the marketing authorization of medicinal products in the MRP and DCP. This guidance does not apply to GCP inspections requested by the EMEA in the context of centralised application procedures nor to routine national inspection programmes.

The Guideline is published in Chapter IV of the Eudralex Volume 10.

Eudralex Volume 10 Clinical Trials - Notice to applicants (this is the official title) is based on the corresponding Directives (2001/20/EC, 2005/28/EC, 2003/94/EC) and summarises existing GCP and GMP guidelines/guidances.

Eudralex Volume 10 Clinical Trials can be found here.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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