EMA/INS/GMP/371598/2025
Versiemijlpaal
Publicatiedatum
2026-02-11
guidelines.detail.timeline.expected_date
Niet opgegeven
Belangrijkste 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).