EMA : Guidance on GMP, GCP and GVP inspections and relevant fees 🇬🇧

The EMA published the version 3.0 of Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA.

This document gives details on GMP, GCP and GVP inspections and the relevant fees payable to the Agency.

The  details of each of the inspections adopted by the Committee(s), including the contact details of the  persons in the inspection services who will be involved can be found in the IRIS Industry portal.

In addition, the applicant/MAH are required to …