Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA

This document provides the guidance for applicants/MAHs involved in GMP, GCP and GVP inspections. These inspections are requested by the Committee for Medicinal Products for Human Use and/or for Veterinary Use in order to verify compliance with GMP, GCP and GVP of centrally authorized products.