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)

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

Gruppe: Gruppe "Gesundheitswesen"

betrifft Sitzung am 02.05.2023

Erstellt am 28.04.2023 von: Gesundheit

Eingelangt am 28.04.2023, U32 Übermittlung

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Datum EU-Datenbanknr. Dokument der EU-Vorlage Sprache Einstufung
28.04.2023 153408/EU XXVII.GP
deutsch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

ANHÄNGE des Vorschlags für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung der für die Europäische Arzneimittel-Agentur geltenden Vorschriften sowie zur Änderung der Verordnung (EG) Nr. 1394/2007 und der Verordnung (EU) Nr. 536/2014 und zur Aufhebung der Verordnung (EG) Nr. 726/2004, der Verordnung (EG) Nr. 141/2000 und der Verordnung (EG) Nr. 1901/2006

Eingelangt am 14.09.2023, U32 Übermittlung

28.04.2023 139056/EU XXVII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

ANNEXES to the 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

Eingelangt am 28.04.2023, U32 Übermittlung

28.04.2023 139059/EU XXVII.GP
englisch PUBLIC

EU-Vorlage: Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document 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

Eingelangt am 28.04.2023, U32 Übermittlung

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Datum Dok.Nr.
Art Betreff
26.04.2023 RAT: CM 2547/23 EUTO
Working Party on Public Health Date: 2 May 2023 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (138770/EU XXVII.GP)
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Link
2023/0131 COD
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Datum Dok.Nr.
Art Betreff
08.12.2023 RAT: 16555/23 EUST
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 [doc. 8758/23 - COM(2023) 193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (165918/EU XXVII.GP)
09.01.2024 RAT: 5143/24 EUST
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 [doc. 8758/23 - COM(2023) 193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (168378/EU XXVII.GP)
23.11.2023 RAT: 15851/23 EUST
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 [doc. 8758/23 - COM(2023) 193] 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 [doc. 8759/23 - COM(2023) 192] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (163220/EU XXVII.GP)
29.11.2023 RAT: 15478/23 EUST
- Proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach [8417/23 - COM(2023)191] - Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Reforming of the pharmaceutical legislation and measures addressing antimicrobial resistance [8415/23 - COM(2023)190] - 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 [8759/23 - COM(2023)192] - 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 [8758/23 - COM(2023)193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Senate of the Parliament of the Czech Republic (164427/EU XXVII.GP)
18.09.2023 RAT: CM 4415/23 EUCM
Consultation of the European Economic and Social Committee by the Council Consultation of the European Committee of the Regions by the Council on a 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 [ref. 2023/0131 (COD) - COM(2023) 193 final - 8758/23 + ADD1-2] (153855/EU XXVII.GP)
08.12.2023 RAT: 16555/23 EUST
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 [doc. 8758/23 - COM(2023) 193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (165918/EU XXVII.GP)
09.01.2024 RAT: 5143/24 EUST
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 [doc. 8758/23 - COM(2023) 193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (168378/EU XXVII.GP)
26.09.2025 RAT: 13078/25 EUST
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)
02.11.2025 RAT: 14576/25 EUST
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)
24.05.2024 RAT: 9840/24 EUST
Revision of the pharmaceutical package - State of play (186128/EU XXVII.GP)
16.05.2025 RAT: 8487/25 EUST
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 (20812/EU XXVIII.GP)
23.11.2023 RAT: 15851/23 EUST
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 [doc. 8758/23 - COM(2023) 193] 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 [doc. 8759/23 - COM(2023) 192] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (163220/EU XXVII.GP)
02.06.2025 RAT: 9270/25 EUST
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)
29.11.2023 RAT: 15478/23 EUST
- Proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach [8417/23 - COM(2023)191] - Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Reforming of the pharmaceutical legislation and measures addressing antimicrobial resistance [8415/23 - COM(2023)190] - 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 [8759/23 - COM(2023)192] - 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 [8758/23 - COM(2023)193] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Senate of the Parliament of the Czech Republic (164427/EU XXVII.GP)
13.12.2024 RAT: 16051/24 EUST
Pharmaceutical package: 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 - State of play and guidance for further work (6844/EU XXVIII.GP)
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Datum Dok.Nr.
Art Betreff
15.11.2023 RAT: CM 5145/23 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 30. November 2023 (10:00 Uhr) (161982/EU XXVII.GP)
29.11.2023 RAT: 15801/23 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 30. November 2023 (10:00 Uhr) (164403/EU XXVII.GP)
15.11.2024 RAT: CM 4965/24 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 2. und 3. Dezember 2024 (9:30 Uhr, 10:00 Uhr) (2806/EU XXVIII.GP)
04.06.2025 RAT: CM 2978/25 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 19. und 20. Juni 2025 (9:30 Uhr, 10:00 Uhr) (23125/EU XXVIII.GP)
10.01.2024 RAT: CM 1090/24 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 18 and 19 January 2024 Time: 10:00, 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (168516/EU XXVII.GP)
03.05.2023 RAT: CM 2628/23 EUTO
Working Party on Pharmaceuticals and Medical Devices - Attachés and Experts Date: 12 May 2023 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (139910/EU XXVII.GP)
11.05.2023 RAT: CM 2897/23 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 12 May 2023 Time: 14:30 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (140573/EU XXVII.GP)
07.11.2023 RAT: CM 5182/23 EUTO
ATT & EXP Pharmaceuticals and Medical Devices Date: 16 November 2023 Time: 14:30 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (160876/EU XXVII.GP)
18.06.2025 RAT: 10018/25 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 19. und 20. Juni 2025 (9:30 Uhr, 10:00 Uhr) (25184/EU XXVIII.GP)
14.02.2024 RAT: CM 1638/24 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 21 February 2024 Time: 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS Date: 22 February 2024 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (173178/EU XXVII.GP)
05.12.2023 RAT: CM 5645/23 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 11 December 2023 Time: 14:30 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (165400/EU XXVII.GP)
25.01.2024 RAT: CM 1256/24 EUTO
Att. Working Party on Pharmaceuticals and Medical Devices Date: 30 January 2024 Time: 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (170471/EU XXVII.GP)
15.11.2023 RAT: CM 5145/23 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 30. November 2023 (10:00 Uhr) (161982/EU XXVII.GP)
29.11.2023 RAT: 15801/23 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 30. November 2023 (10:00 Uhr) (164403/EU XXVII.GP)
15.11.2024 RAT: CM 4965/24 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Europa-Gebäude, Brüssel 2. und 3. Dezember 2024 (9:30 Uhr, 10:00 Uhr) (2806/EU XXVIII.GP)
04.06.2025 RAT: CM 2978/25 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 19. und 20. Juni 2025 (9:30 Uhr, 10:00 Uhr) (23125/EU XXVIII.GP)
28.04.2023 RAT: 8615/23 EUTO
AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Justus-Lipsius-Gebäude, Brüssel 3. Mai 2023 (11:00 Uhr) (139316/EU XXVII.GP)
18.06.2025 RAT: 10018/25 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 19. und 20. Juni 2025 (9:30 Uhr, 10:00 Uhr) (25184/EU XXVIII.GP)
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