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Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on advanced therapy medicinal products (Articles) (53364/EU XXVIII.GP)

EU-V: Arbeitsdokument

Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on advanced therapy medicinal products (Articles)

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzung am 14.01.2026

Erstellt am 13.01.2026

Eingelangt am 14.01.2026, CIxP Übermittlung

  • RAT: WK 482/26

Dokumente, die sich auch auf die gegenständliche Sitzung (Gremium und Datum) beziehen.
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Datum Dok.Nr.
Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.
Art Betreff
17.12.2025 RAT: 16919/25 EUST
EU-Vorlage: Offizielles Ratsdokument
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I (51578/EU XXVIII.GP)
21.12.2025 RAT: 16945/25 EUST
EU-Vorlage: Offizielles Ratsdokument
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (52034/EU XXVIII.GP)
06.01.2026 RAT: WK 74/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I/Consolidated version of proposed amendments to the MDR Regulation (Articles) (52571/EU XXVIII.GP)
06.01.2026 RAT: WK 79/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices (IVDR), and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I/Consolidated version of proposed amendments to the IVDR Regulation (Articles) (52572/EU XXVIII.GP)
06.01.2026 RAT: CM 5535/25 EUTO
EU-Vorlage Tagesordnung
Working Party on Pharmaceuticals and Medical Devices Date: 14 January 2026 Time: 10:00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (52593/EU XXVIII.GP)
11.01.2026 RAT: WK 341/26 EUWK
Arbeitsdokument
Flash from the Presidency for the Working Party on Pharmaceuticals and Medical Devices on 14 January 2026 (53136/EU XXVIII.GP)
13.01.2026 RAT: WK 345/26 EUWK
Arbeitsdokument
Presentation by the Commission on the Regulation to simplify rules on medical and in vitro daignostic devcies (53396/EU XXVIII.GP)
13.01.2026 RAT: WK 468/26 EUWK
Arbeitsdokument
Report on Cybersecurity of connected medical devices – where we are and what’s next/Presentation (53460/EU XXVIII.GP)
13.01.2026 RAT: WK 486/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on the Strategic Technologies for Europe Platform (STEP) (Articles) (53369/EU XXVIII.GP)
13.01.2026 RAT: WK 480/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on clinical trials on medicinal products for human use (CTR) (Articles) (53363/EU XXVIII.GP)
13.01.2026 RAT: WK 483/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on standards of quality and safety for substances of human origin intended for human application (Articles) (53366/EU XXVIII.GP)
13.01.2026 RAT: WK 485/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on General Food Law (Articles) (53370/EU XXVIII.GP)
13.01.2026 RAT: WK 484/26 EUWK
Arbeitsdokument
Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)/Consolidated version of proposed amendments to the Biotech Act (Regulation) on veterinary medicinal products (Articles) (53367/EU XXVIII.GP)
13.01.2026 RAT: WK 344/26 EUWK
Arbeitsdokument
Working Party on Pharmaceuticals and Medical Devices 14 January 2026 (53471/EU XXVIII.GP)
Gesetzgebungsvorhaben der Kommission erhalten eine fortlaufende Nummer mit Jahresangabe und Kürzel des Verfahrens (z.B.: COD, NLE). Diese Zahl wird von den beteiligten EU-Institutionen über sämtliche Etappen eines Verfahrens bis zur Annahme verwendet. Dies ermöglicht die Zusammenstellung vollständiger Dossiers
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Interinstitutionelle Zahl
Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.
Link
2025/0406 COD Legislative Observatory
Zusätzliche Dokumente, auf die im Text Bezug genommen oder verwiesen wird (Vordokumente und sonstige Verweise)
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Mit den Sachgebietscodes werden die in einem Dokument behandelten Themenbereiche des Rates ausgewiesen. Der Link führt zu Dokumenten mit dem gleichen Sachgebiet
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Dieser Link führt zum Filter für die Dokumentenauswahl nach übergeordneten Themen
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