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Eudralex Volume 10 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

Short Title:
Guidance for coordination of GCP inspections and co-operation b
Origin/Publisher:

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals

Document Type:
Guidance
Content:
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, e.g. planned inspections unrelated to an authorisation application. However, this guidance does apply to all GCP inspections conducted in relation to an MRP/DCP application, whether it involves inspection activity in more than one Member State or not, as information will be shared with concerned Member States.

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