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 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 (179057/EU XXVII.GP)

EU-V: U32 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 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

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzungen am 08.04.2024 und 09.04.2024

Erstellt am 02.04.2024 von: Gesundheit

Eingelangt am 02.04.2024, U32 Übermittlung

RAT: 8232/24

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
26.03.2024	RAT: CM 2258/24	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 8 and 9 April 2024 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (178671/EU XXVII.GP)
26.03.2024	RAT: CM 2258/24	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 8 and 9 April 2024 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (178671/EU XXVII.GP)
02.04.2024	RAT: 8216/24	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 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 (179053/EU XXVII.GP)
02.04.2024	RAT: 8216/24	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 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 (179053/EU XXVII.GP)
08.04.2024	RAT: WK 5056/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Unmet medical need (UMN) and high unmet medical need (HUMN) criteria in the proposed pharmaceutical reform/Presentation by the Commission (181056/EU XXVII.GP)
08.04.2024	RAT: WK 5056/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Unmet medical need (UMN) and high unmet medical need (HUMN) criteria in the proposed pharmaceutical reform/Presentation by the Commission (181056/EU XXVII.GP)
09.04.2024	RAT: WK 5008/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Pharma package – clusters shortages and incentives/Presentations by the Presidency (181055/EU XXVII.GP)
09.04.2024	RAT: WK 5008/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Pharma package – clusters shortages and incentives/Presentations by the Presidency (181055/EU XXVII.GP)

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

Code	Sachgebiet
SAN 201	Gesundheit
PHARM 51	Pharmazie
MI 367	Binnenmarkt
COMPET 375	Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
VETER 42	Veterinärfragen
ENV 370	Umwelt
RECH 142	Forschung (Allgemein)
CODEC 920	Mitentscheidungsverfahren
PI 40	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
22.05.2024	RAT: 9622/24	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 (185600/EU XXVII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
26.03.2024	RAT: CM 2258/24	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 8 and 9 April 2024 Time: 10:00, 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (178671/EU XXVII.GP)