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GMP Draft

Annex 6 - Manufacture of Medicinal Gases

This Annex deals with the manufacture of active substance gases and with the manufacture of medicinal gases.

Organisations:
Pharmaceutical Inspection Co-operation Scheme (PIC/S) EMA
Topics:
Medicinal Gases

Version Timeline

Chronological release history

EMA/INS/GMP/371598/2025

Version milestone

Draft

Publication Date

11 Feb 2026

guidelines.detail.timeline.expected_date

Not specified

Main updates: A targeted update of EU GMP Annex 6 is proposed to align it with current industry practice and technology, clarify areas of ambiguity, strengthen quality documentation requirements (e.g., for liquid oxygen supply to hospitals), and consider specific GMP-related aspects for medicinal gases (including batch release processes and facility/containers qualification).
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ENTR/F/2/AM/an D(2010) 3374

Version milestone

Publication Date

03 Feb 2010

Effective Date

31 Jul 2010

Main updates: This is the current, active version of this annex.
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