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)

EU-V: U32 Offizielles Ratsdokument

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

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

betrifft Sitzung am 18.12.2024

Erstellt am 13.12.2024 von: Gesundheit

Eingelangt am 14.12.2024, U32 Übermittlung

RAT: 16051/24

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
09.12.2024	RAT: 16683/24	EUST EU-Vorlage: Offizielles Ratsdokument	Response to the European Court of Auditors’ Special report 21/2024: State aid in times of crisis (5868/EU XXVIII.GP)
11.12.2024	RAT: 16805/24	EUST EU-Vorlage: Offizielles Ratsdokument	Case brought before the General Court - T-486/24 NKL Associates s.r.o. v Commission - Plea of illegality against Article 39 of the Digital Services Act (6336/EU XXVIII.GP)
12.12.2024	RAT: 16796/24	EUST EU-Vorlage: Offizielles Ratsdokument	Attendance of third party at the Working Party on Competitiveness and Growth (Industry) on 8 January 2025 - Approval (6520/EU XXVIII.GP)
13.12.2024	RAT: 16821/24	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European Union labour market statistics on businesses, repealing Council Regulation (EC) No 530/1999 and Regulations (EC) No 450/2003 and (EC) No 453/2008 of the European Parliament and of the Council - Analysis of the final compromise text with a view to agreement (6852/EU XXVIII.GP)
13.12.2024	RAT: 16752/24	EUST EU-Vorlage: Offizielles Ratsdokument	The role of the EUIPO in the area of IPR protection and management - Approval of a letter (6842/EU XXVIII.GP)
13.12.2024	RAT: 16753/24	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a Directive of the European Pariliament and of the Council amending Directive (EU) 2015/2302 to make the protection of travellers more effective and to simplify and clarify certain aspects of the Directive - Mandate for negotiations with the European Parliament (6855/EU XXVIII.GP)
13.12.2024	RAT: 16732/24	EUST EU-Vorlage: Offizielles Ratsdokument	Supplementary protection certificate proposals (SPCs): Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the supplementary protection certificate for plant protection products (recast); Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the supplementary protection certificate for medicinal products (recast); Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary protection certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013; and Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary protection certificate for plant protection products - State of play (6860/EU XXVIII.GP)
13.12.2024	RAT: 16887/24	EUST EU-Vorlage: Offizielles Ratsdokument	Endorsement of the Ministerial Declaration of the Summit of the Global Partnership on Artificial Intelligence (GPAI) held in Belgrade on 3-4 December 2024 - Approval of an NBI - Decision to use the written procedure (6823/EU XXVIII.GP)
13.12.2024	RAT: 16848/24	EUST EU-Vorlage: Offizielles Ratsdokument	Antwort auf das Schreiben zur Entwaldungsverordnung (EUDR) – Billigung eines Schreibens – Beschluss über die Anwendung des schriftlichen Verfahrens (7134/EU XXVIII.GP)
13.12.2024	RAT: CM 5406/24	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Lex-Gebäude, Brüssel 18. Dezember 2024 (9:00 Uhr) (6933/EU XXVIII.GP)
16.12.2024	NON: 839/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 18 December 2024/Coreper I Flash (7035/EU XXVIII.GP)
16.12.2024	RAT: 16865/24	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a COUNCIL REGULATION fixing for 2025 and 2026 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters - Political agreement (6929/EU XXVIII.GP)
16.12.2024	RAT: 15825/24	EUST EU-Vorlage: Offizielles Ratsdokument	Public access to documents - Confirmatory application No 29/c/01/24 - decision to use the written procedure for approval (6946/EU XXVIII.GP)
16.12.2024	RAT: 16922/24	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Lex-Gebäude, Brüssel 18. Dezember 2024 (9:00 Uhr) (7101/EU XXVIII.GP)
17.12.2024	NON: 843/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper I, 18 December 2024/Revised Coreper I Flash (7175/EU XXVIII.GP)
17.12.2024	RAT: WK 15925/24	EUB EU-Vorlage Berichte u. Beratungsergebnisse	Coreper (Part 1) on 18 December 2024/Pre-Mertens list of reserves (7171/EU XXVIII.GP)
17.12.2024	RAT: 16888/24	EUST EU-Vorlage: Offizielles Ratsdokument	“Lausanne Call for Action” issued at the Ukraine Mine Action Conference (Lausanne, 17-18 October 2024) - Approval of an NBI (Step 2) - Decision to use the written procedure (7056/EU XXVIII.GP)
18.12.2024	RAT: CM 5453/24	EUCM EU-Vorlage: Kommunikationsdokument	SCHRIFTLICHES VERFAHREN zur Billigung der Ministererklärung des Gipfeltreffens der Globalen Partnerschaft für künstliche Intelligenz (GPAI) vom 3./4. Dezember 2024 in Belgrad – Billigung nicht verbindlicher Instrumente – Einleitung des schriftlichen Verfahrens (7240/EU XXVIII.GP)
18.12.2024	RAT: CM 5468/24	EUCM EU-Vorlage: Kommunikationsdokument	Ermächtigung der Kommission zur schriftlichen Bekundung der Unterstützung der EU für den Aufruf von Lausanne (Lausanne Call for Action) im Rahmen der Ukraine Mine Action Conference (Lausanne, 17./18. Oktober 2024) – Billigung – Einleitung des schriftlichen Verfahrens (7263/EU XXVIII.GP)
18.12.2024	RAT: CM 5147/24	EUCM EU-Vorlage: Kommunikationsdokument	ZUGANG DER ÖFFENTLICHKEIT ZU DOKUMENTEN – Zweitantrag Nr. 29/c/01/24 – Einleitung des schriftlichen Verfahrens (7646/EU XXVIII.GP)
18.12.2024	RAT: CM 5483/24	EUCM EU-Vorlage: Kommunikationsdokument	Antwort auf das Schreiben zur Entwaldungsverordnung (EUDR) – Billigung eines Schreibens (7230/EU XXVIII.GP)
14.01.2025	RAT: 17047/24	EUST EU-Vorlage: Offizielles Ratsdokument	SUMMARY RECORD PERMANENT REPRESENTATIVES COMMITTEE 18 and 20 December 2024 (8432/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. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Betreff
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: 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)

Dok.Nr.

Betreff

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: 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)

Code	Sachgebiet
SAN 668	Gesundheit
PHARM 160	Pharmazie
MI 967	Binnenmarkt
COMPET 1143	Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
VETER 147	Veterinärfragen
ENV 1145	Umwelt
RECH 511	Forschung (Allgemein)
CODEC 2191	Mitentscheidungsverfahren
PI 194	Geistiges Eigentum

Thema
Binnenmarkt und Wettbewerb
Energie
Forschung und Innovation
Gesundheitswesen
Institutionelle Fragen
Justiz und Inneres
Kultur
Landwirtschaft
Umwelt
Verbraucher- und Lebensmittelsicherheit
Wirtschaft, Währung & Finanzen

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
28.03.2025	RAT: 7201/25	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 (15918/EU XXVIII.GP)
31.01.2025	RAT: 5727/25	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 (10123/EU XXVIII.GP)
31.01.2025	RAT: 5735/25	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 (10124/EU XXVIII.GP)
28.03.2025	RAT: 7200/25	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 (15917/EU XXVIII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
09.04.2025	RAT: CM 2334/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 15 April 2025 Time: 10:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (17140/EU XXVIII.GP)
22.04.2025	RAT: CM 2336/25	EUTO EU-Vorlage Tagesordnung	Working Party on Pharmaceuticals and Medical Devices Date: 28 April 2025 Time: 09:00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (17997/EU XXVIII.GP)
13.12.2024	RAT: CM 5406/24	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Lex-Gebäude, Brüssel 18. Dezember 2024 (9:00 Uhr) (6933/EU XXVIII.GP)
16.12.2024	RAT: 16922/24	EUTO EU-Vorlage Tagesordnung	AUSSCHUSS DER STÄNDIGEN VERTRETER (1. Teil) Lex-Gebäude, Brüssel 18. Dezember 2024 (9:00 Uhr) (7101/EU XXVIII.GP)