Pharmaceutical package a) Directive on the Union code relating to medicinal products for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rulesgoverning the European Medicines Agency - Analysis of the final compromise text with a view to agreement (60640/EU XXVIII.GP)

EU-V: U32 Offizielles Ratsdokument

Pharmaceutical package a) Directive on the Union code relating to medicinal products for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rulesgoverning the European Medicines Agency - Analysis of the final compromise text with a view to agreement

Gruppe: Ausschuss der Ständigen Vertreter (AStV) - 1. Teil

betrifft Sitzung am 06.03.2026

Erstellt am 23.02.2026 von: Generalsekretariat des Rates

Eingelangt am 24.02.2026, CIxP Übermittlung

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Datum Dok.Nr.
Art Betreff
23.02.2026 RAT: 6366/26 EUST
Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rulesgoverning the European Medicines Agency - Analysis of the final compromise text with a view to agreement (60634/EU XXVIII.GP)
23.02.2026 RAT: 6367/26 EUST
Directive on the Union code relating to medicinal products for human use - Analysis of the final compromise text with a view to agreement (60637/EU XXVIII.GP)
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Interinstitutionelle Zahl
Link
2023/0131 COD
2023/0132 COD
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Dok.Nr.
Betreff
RAT: 8759/23 Vorschlag für eine RICHTLINIE DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG (153439/EU XXVII.GP)
RAT: 8758/23 Proposal for 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 Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (139055/EU XXVII.GP)
RAT: 15273/23 Proposal for 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 Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 - Renunciation letter from the Committee of the Regions (CoR) (161075/EU XXVII.GP)
RAT: 14863/23 Opinion of the European Economic and Social Committee on files 2023/0132 (COD) and 2023/0131 (COD) (159552/EU XXVII.GP)
RAT: 6366/26 Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rulesgoverning the European Medicines Agency - Analysis of the final compromise text with a view to agreement (60634/EU XXVIII.GP)
RAT: 6367/26 Directive on the Union code relating to medicinal products for human use - Analysis of the final compromise text with a view to agreement (60637/EU XXVIII.GP)
RAT: 9270/25 Pharmaceutical package a) Directive on the Union code relating to medicinal product for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - Mandate for negotiations with the European Parliament (22506/EU XXVIII.GP)
RAT: 13078/25 Pharmaceutical package a) Directive on the Union code relating to medicinal products for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - Preparation for the trilogue (34618/EU XXVIII.GP)
RAT: 14576/25 Pharmaceutical package a) Directive on the Union code relating to medicinal products for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - Preparation for the trilogue (42006/EU XXVIII.GP)
RAT: 15902/25 Pharmaceutical package a) Directive on the Union code relating to medicinal products for human use b) Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - Preparation for the trilogue (47755/EU XXVIII.GP)
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