Concept paper on revision of the guidelines on good manufacturing practice for medicinal products - annex 6 manufacture of medicinal gases

18th February 2026

Summary: This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.

Those participating in the public consultation are asked to please submit comments via the EU Survey tool

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