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Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views (13327/EU XXVIII.GP)

EU-V: U32 Offizielles Ratsdokument

Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzungen am 12.03.2025 und 13.03.2025

Erstellt am 04.03.2025 von: Gesundheit

Eingelangt am 04.03.2025, U32 Übermittlung

RAT: 6682/25

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
07.03.2025	13792/EU XXVIII.GP	RAT: 6682/25 REV 1	englisch	LIMITE	EU-Vorlage: Offizielles Ratsdokument Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views Eingelangt am 07.03.2025, U32 Übermittlung

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
04.03.2025	RAT: 6680/25	EUST EU-Vorlage: Offizielles Ratsdokument	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 - Exchange of views (13323/EU XXVIII.GP)
04.03.2025	RAT: 6680/25	EUST EU-Vorlage: Offizielles Ratsdokument	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 - Exchange of views (13323/EU XXVIII.GP)
06.03.2025	RAT: 6630/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC - Exchange of views (13540/EU XXVIII.GP)
06.03.2025	RAT: 6633/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views (13544/EU XXVIII.GP)
06.03.2025	RAT: 6633/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views (13544/EU XXVIII.GP)
06.03.2025	RAT: 6630/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC - Exchange of views (13540/EU XXVIII.GP)
06.03.2025	RAT: CM 1863/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 12 and 13 March 2025 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (13568/EU XXVIII.GP)
06.03.2025	RAT: CM 1863/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 12 and 13 March 2025 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (13568/EU XXVIII.GP)

Interinstitutionelle Zahl Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.	Link
2023/0131 COD	Legislative Observatory
2023/0132 COD	Legislative Observatory

Dok.Nr.

Betreff

RAT: 5735/25

Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 - Exchange of views (10124/EU XXVIII.GP)

Code	Sachgebiet
SAN 73	Gesundheit
PHARM 25	Pharmazie
MI 111	Binnenmarkt
COMPET 107	Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
VETER 25	Veterinärfragen
ENV 114	Umwelt
RECH 75	Forschung (Allgemein)
CODEC 195	Mitentscheidungsverfahren
PI 39	Geistiges Eigentum

Thema
Binnenmarkt und Wettbewerb
Forschung und Innovation
Gesundheitswesen
Institutionelle Fragen
Justiz und Inneres
Kultur
Landwirtschaft
Umwelt
Verbraucher- und Lebensmittelsicherheit

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
21.03.2025	RAT: 7213/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 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 (15144/EU XXVIII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
06.03.2025	RAT: CM 1863/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 12 and 13 March 2025 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (13568/EU XXVIII.GP)