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

On 31 August 2022 the EMA published guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, version 3.0.

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.

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