European Commission: 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 applicatio

08.06.2009

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.