PIC/S Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5

11th November 2021

Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5

The PIC/S Working Group on Veterinary Medicinal Products (VMP), led by Grégory Verdier (France / ANSES), and the EMA GMP/GDP Inspectors Working Group have jointly developed two concept papers on the revision of Annex 4 (manufacture of veterinary medicinal products other than immunologicals) and Annex 5 (manufacture of immunological veterinary medicinal products) of the EU-PIC/S GMP Guide.

These concept papers are submitted to a joint PIC/S-EMA public consultation from 9 November 2021 until 9 January 2022 and can be downloaded on the PIC/S website (https://picscheme.org/en/publications?tri=draft#zone) as well as on the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/gmp-gdp-inspectors-working-group#concept-papers,-reflection-papers-and-draft-guidelines-section)

Comments should be sent to ADM-GMDP@ema.europa.eu using the EMA template downloadable via the link provided in the Concept Papers by 9 January 2022.

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