Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795 (19957/EU XXVIII.GP)

Linkart	Link
COM Kommission	COM(2019) 196
COM Kommission	COM(2023) 192
COM Kommission	COM(2023) 193
COM Kommission	COM(2025) 102
INT Interinstitutionelle Zahl	2025/0102 (COD)
RMA Ratsmateriencodes	CODEC 223
RMA Ratsmateriencodes	COMPET 132
RMA Ratsmateriencodes	IND 66
RMA Ratsmateriencodes	MAP 3
RMA Ratsmateriencodes	MI 127
RMA Ratsmateriencodes	PHARM 26
RMA Ratsmateriencodes	SAN 88
ABL Amtsblatter	ABl. L 107 vom 26.3.2021
ABL Amtsblatter	ABl. L 107 vom 26.3.2021, S. 1
ABL Amtsblatter	ABl. L 166 vom 11.5.2021, S. 1
ABL Amtsblatter	ABl. L 170 vom 12.5.2021, S. 1
ABL Amtsblatter	ABl. L 197 vom 21.7.2001, S. 30
ABL Amtsblatter	ABl. L 197 vom 24.7.2012, S. 1
ABL Amtsblatter	ABl. L 20 vom 26.1.2010, S. 7
ABL Amtsblatter	ABl. L 20 vom 31.2.2022, S. 1
ABL Amtsblatter	ABl. L 206 vom 22.7.1992, S. 7
ABL Amtsblatter	ABl. L 257 vom 28.8.2014, S. 135
BES Beschlusse	Nr. 1082/2013/EU
BES Beschlusse	2003/87/EG
BES Beschlusse	2015/2240
BES Beschlusse	2016/296
BES Beschlusse	2016/369
BES Beschlusse	2021/1056
BES Beschlusse	2021/1057
BES Beschlusse	2021/1058
BES Beschlusse	2021/1060
BES Beschlusse	2021/241
RIL Richtlinien	(EU) 2022/2555
RIL Richtlinien	2000/60/EG
RIL Richtlinien	2001/42/EG
RIL Richtlinien	2003/87/EG
RIL Richtlinien	2004/18/EG
RIL Richtlinien	2008/98/EG
RIL Richtlinien	2009/147/EG
RIL Richtlinien	2010/75/EU
RIL Richtlinien	2011/24/EU
RIL Richtlinien	2011/92/EU
VER Verordnungen	1082/2013
VER Verordnungen	1290/2013
VER Verordnungen	1291/2013
VER Verordnungen	1303/2013
VER Verordnungen	1394/2007
VER Verordnungen	141/2000
VER Verordnungen	1901/2006
VER Verordnungen	2003/87
VER Verordnungen	2004/18
VER Verordnungen	2014/24

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
12.03.2025	14220/EU XXVIII.GP	RAT: 6872/25 PDF	englisch	PUBLIC	EU-Vorlage: Offizielles Ratsdokument Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 Eingelangt am 12.03.2025, 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: 6718/25	EUST EU-Vorlage: Offizielles Ratsdokument	Case before the Court of Justice of the European Union: Case C-118/25 P (Nord Stream 2 AG) - appeal lodged against the judgment of the General Court in Case T-526/19 RENV (internal market in natural gas) (13252/EU XXVIII.GP)
05.03.2025	RAT: 6794/25	EUST EU-Vorlage: Offizielles Ratsdokument	Attendance of third parties at the informal videoconference of the members of the Working Party on International Environment Issues (Desertification) on 19 March 2025 - Approval (13685/EU XXVIII.GP)
06.03.2025	RAT: 6735/25	EUST EU-Vorlage: Offizielles Ratsdokument	Attendance of third parties at the Working Party on Competitiveness and Growth (Internal Market) on 17 March 2025 - Approval (13555/EU XXVIII.GP)
07.03.2025	RAT: 6426/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 - Mandate for negotiations with the European Parliament (13757/EU XXVIII.GP)
07.03.2025	RAT: 6479/25	EUST EU-Vorlage: Offizielles Ratsdokument	Aktionsplan für erschwingliche Energie – Orientierungsaussprache (14381/EU XXVIII.GP)
07.03.2025	RAT: CM 1790/25	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 14. März 2025 (9:00 Uhr) (13883/EU XXVIII.GP)
10.03.2025	NON: 179/25	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 14 March 2025/Coreper I Flash (14008/EU XXVIII.GP)
10.03.2025	RAT: 6755/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC - Preparation for the trilogue (13928/EU XXVIII.GP)
12.03.2025	NON: 183/25	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 14 March 2025/Revised Coreper I Flash (14272/EU XXVIII.GP)
12.03.2025	RAT: 6913/25	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 14. März 2025 (9:00 Uhr) (14298/EU XXVIII.GP)
13.03.2025	RAT: WK 2932/25	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper (Part 1) on 14 March 2025/Pre-Mertens list of reserves (14425/EU XXVIII.GP)
27.03.2025	RAT: 7093/25	EUST EU-Vorlage: Offizielles Ratsdokument	SUMMARY RECORD PERMANENT REPRESENTATIVES COMMITTEE 12, 13, 14 and 17 March 2025 (15761/EU XXVIII.GP)

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Betreff
COM: COM(2025) 102	Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795 (Text von Bedeutung für den EWR) (19880/EU XXVIII.GP)

Dok.Nr.

Betreff

COM: COM(2025) 102

Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795 (Text von Bedeutung für den EWR) (19880/EU XXVIII.GP)

Interinstitutionelle Zahl Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.	Link
2025/0102 COD	Legislative Observatory

Code	Sachgebiet
SAN 88	Gesundheit
PHARM 26	Pharmazie
MI 127	Binnenmarkt
MAP 3	Öffentliche Aufträge
POLCOM 52	Handelspolitik
IND 66	Industrie
COMPET 132	Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
CODEC 223	Mitentscheidungsverfahren

Thema
Außenhandel und Zoll
Binnenmarkt und Wettbewerb
Energie
Gesundheitswesen
Institutionelle Fragen
Wirtschaft, Währung & Finanzen

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
19.06.2025	RAT: 10597/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish parliament (Cortes Generales) (25336/EU XXVIII.GP)
19.06.2025	RAT: 10600/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Swedish Riksdag (25416/EU XXVIII.GP)
25.06.2025	RAT: 10807/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (26090/EU XXVIII.GP)
25.06.2025	RAT: 10808/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Czech Senate (26097/EU XXVIII.GP)
27.06.2025	RAT: 10943/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (26402/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)
16.07.2025	RAT: 11666/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025) 102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (29004/EU XXVIII.GP)
30.07.2025	RAT: 11992/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality (30164/EU XXVIII.GP)
13.05.2025	RAT: CM 2768/25	EUCM EU-Vorlage: Kommunikationsdokument	Consultation of the European Economic and Social Committee by the Council on a proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [ref. 2025/0102 (COD) - COM(2025) 102 final - 6872/25 (20205/EU XXVIII.GP)
12.09.2025	RAT: 12773/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 - Presidency's first compromise proposal (32634/EU XXVIII.GP)
28.10.2025	RAT: 14570/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 - Presidency's compromise proposal (Recitals) (41184/EU XXVIII.GP)
30.07.2025	RAT: 11992/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality (30164/EU XXVIII.GP)
12.09.2025	RAT: 12773/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 - Presidency's first compromise proposal (32634/EU XXVIII.GP)
03.06.2025	RAT: 9097/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 - Optional consultation of the Committee of the regions1 (22663/EU XXVIII.GP)
09.10.2025	RAT: 13579/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 - Guidance for further work (37749/EU XXVIII.GP)
19.06.2025	RAT: 10597/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish parliament (Cortes Generales) (25336/EU XXVIII.GP)
19.06.2025	RAT: 10600/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Swedish Riksdag (25416/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)
25.06.2025	RAT: 10807/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (26090/EU XXVIII.GP)
25.06.2025	RAT: 10808/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Czech Senate (26097/EU XXVIII.GP)
27.06.2025	RAT: 10943/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (26402/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)
16.07.2025	RAT: 11666/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025) 102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (29004/EU XXVIII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
08.07.2025	RAT: CM 3549/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 15 July 2025 Time: 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (27901/EU XXVIII.GP)
27.08.2025	RAT: CM 3783/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 3 and 4 September 2025 Time: 11:00, 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (30868/EU XXVIII.GP)
26.06.2025	RAT: CM 3353/25	EUTO EU-Vorlage Tagesordnung	Meeting of the Working Party on Public Health and of the Working Party on Pharmaceuticals and Medical Devices Date: 3 and 4 July 2025 Time: 10:00, 10:00 Venue: COUNCIL EUROPA BUILDING Rue de la Loi 167, 1048 BRUSSELS (26273/EU XXVIII.GP)
16.07.2025	RAT: CM 3647/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 23 July 2025 Time: 10:00 Venue: COUNCIL EUROPA BUILDING Rue de la Loi 167, 1048 BRUSSELS Date: 24 July 2025 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (29031/EU XXVIII.GP)
03.04.2025	RAT: CM 2170/25	EUTO EU-Vorlage Tagesordnung	Working Party on Competitiveness and Growth (Industry) Date: 10 April 2025 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (16598/EU XXVIII.GP)
12.05.2025	RAT: CM 2731/25	EUTO EU-Vorlage Tagesordnung	Working Party on Competitiveness and Growth (Public Procurement) Date: 28 May 2025 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (20039/EU XXVIII.GP)
01.04.2025	RAT: CM 2231/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 8 April 2025 Time: 10:00 Venue: COUNCIL EUROPA BUILDING Rue de la Loi 167, 1048 BRUSSELS (16318/EU XXVIII.GP)
12.03.2025	RAT: 6913/25	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 14. März 2025 (9:00 Uhr) (14298/EU XXVIII.GP)
07.03.2025	RAT: CM 1790/25	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Europa-Gebäude, Brüssel 14. März 2025 (9:00 Uhr) (13883/EU XXVIII.GP)

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Links
COM: COM(2025) 102	EUR-Lex IPEX

EU-V: U32 Offizielles Ratsdokument

EU-Vorlage: Offizielles Ratsdokument