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

13 December 2022 – the EMA published version 3.1 of guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA.

These GMP inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) and/or the Committee for Medicinal Products for Veterinary Use (CVMP) in order to verify compliance with GMP of sites responsible for the manufacture of centrally authorized products.

These GCP inspections are requested by the CHMP in order to verify compliance with GCP for centrally authorized products, in accordance with Article 57 of Regulation (EC) No. 726/2004 and Article 78 of Regulation (EU) No 536/2014.

These GVP inspections are requested by the CHMP in order to verify compliance with GVP for centrally authorized products, in accordance with Article 57 of Regulation (EC) No. 726/2004 and CVMP, in accordance with Article 57 of Regulation (EC) No. 726/2004 and Articles 123 and 126 of Regulation (EU) 2019/6.

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