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Statement of the Council's reasons: Position (EU) No 12/2026 of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulations (EC) No 1394/2007 and (EU) No 536/2014 and repealing Regulations (EC) No 141/2000, (EC) No 726/2004 and (EC) No 1901/2006 – Adopt

52026AG0012(02) · AG · 2026-10-16 · sector 5

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