Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und zur Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG (Text von Bedeutung für den EWR) (108659/EU XXVII.GP)

COM: COM(2022) 338 PUBLIC
14.07.2022
deutsch
Frist: 13.10.2022

EU-V: Verordnungsentwürfe

Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und zur Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG (Text von Bedeutung für den EWR)

Erstellt am 14.07.2022

Eingelangt am 14.07.2022, Europäische Kommission - Österr. Parlament

COM: COM(2022) 338 final PDF

Linkart	Link
COM	COM(2019) 196
COM	COM(2020) 726
COM	C(2016) 3301
COM	SEC(2022) 304
COM	SWD(2019) 376
COM	SWD(2022) 189
COM	SWD(2022) 190
COM	SWD(2022) 191
INT	2022/0216 (COD)
RAT	2004/23
RAG	Verkehr
ABL	ABl. L 102 vom 7.4.2004, S. 48
ABL	ABl. L 107 vom 26.3.2021, S. 1
ABL	ABl. L 117 vom 5.5.2017, S. 1
ABL	ABl. L 123 vom 12.5.2016, S. 1
ABL	ABl. L 136 vom 30.4.2004, S. 1
ABL	ABl. L 142 vom 30.4.2004, S. 1
ABL	ABl. L 145 vom 31.5.2001, S. 43
ABL	ABl. L 158 vom 25.6.1994, S. 17
ABL	ABl. L 158 vom 27.5.2014, S. 1
ABL	ABl. L 159 vom 27.6.2003, S. 46
ABL	ABl. L 207 vom 6.8.2010, S. 14
ABL	ABl. L 311 vom 28.11.2001, S. 67
ABL	ABl. L 324 vom 10.12.2007, S. 121
ABL	ABl. L 33 vom 8.2.2003, S. 30
ABL	ABl. L 404 vom 30.12.2006, S. 26
ABL	ABl. L 55 vom 28.2.2011, S. 13
ABL	ABl. L 57 vom 18.2.2021, S. 1
BES	94/358/EG
RIL	2001/20/EG
RIL	2001/83/EG
RIL	2002/98/EG
RIL	2003/63/EG
RIL	2004/23/EG
RIL	2006/86/EG
RIL	2010/53/EU
RIL	90/385/EWG
RIL	93/42/EWG
VER	1049/2001
VER	1223/2009
VER	1394/2007
VER	178/2002
VER	182/2011
VER	1925/2006
VER	2001/83
VER	2010/53
VER	2016/67
VER	2017/74
VER	2018/1725
VER	2021/240
VER	2021/52
VER	282/2014
VER	536/2014
VER	726/2004
VER	851/2004

Interinstitutionelle Zahl	Link
2022/0216 COD	Legislative Observatory

Dok.Nr.	Betreff
COM: SEC(2022) 304	Regulatory Scrutiny Board Opinion/Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108660/EU XXVII.GP)
COM: SWD(2022) 189	Commission Staff Working Document/Subsidiarity Grid/Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108663/EU XXVII.GP)
COM: SWD(2022) 190	Commission Staff Working Document/Impact Assessment Report/Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108662/EU XXVII.GP)
COM: SWD(2022) 191	Arbeitsunterlage der Kommissionsdienststellen/Bericht über die Folgenabschätzung (Zusammenfassung)/Begleitunterlage zum Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und zur Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG (108661/EU XXVII.GP)

Thema
Gesundheitswesen

Datum	Dok.Nr.	Art	Betreff
18.07.2022	COM: D(2022) 13291	EUUS	Übermittlungsschreiben/COM(2022) 338/Fristbeginn: 18.7.2022 (109098/EU XXVII.GP)
10.12.2021	COM: SEC(2022) 304	EUES	Regulatory Scrutiny Board Opinion/Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108660/EU XXVII.GP)
14.07.2022	COM: SWD(2022) 189	EUB	Commission Staff Working Document/Subsidiarity Grid/Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108663/EU XXVII.GP)
14.07.2022	COM: SWD(2022) 190	EUB	Commission Staff Working Document/Impact Assessment Report/Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (108662/EU XXVII.GP)
14.07.2022	COM: SWD(2022) 191	EUB	Arbeitsunterlage der Kommissionsdienststellen/Bericht über die Folgenabschätzung (Zusammenfassung)/Begleitunterlage zum Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und zur Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG (108661/EU XXVII.GP)
23.02.2023	RAT: WK 2726/23	EUB	Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC/Presentation by the Commission (134066/EU XXVII.GP)
01.03.2023	RAT: WK 2950/23	EUB	Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC/Presentation by the Commission (134067/EU XXVII.GP)
25.01.2023	RAT: WK 1067/23	EUB	Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC ("SOHO" proposal)/Presentation by the Commission (129081/EU XXVII.GP)
19.09.2022	RAT: WK 12105/22	EUB	Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC/Presentation by the Commission (112946/EU XXVII.GP)
18.10.2022	RAT: WK 14032/22	EUB	Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC/Presentation by the Commission (116726/EU XXVII.GP)
06.10.2022	RAT: 13266/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish Parliament (Cortes Generales) (115020/EU XXVII.GP)
11.10.2022	RAT: 13409/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Portuguese Parliament (Assembleia da República) (115576/EU XXVII.GP)
19.10.2022	RAT: 13596/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Parliament of the Czech Republic (116744/EU XXVII.GP)
18.07.2022	RAT: CM 4049/22	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 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [ref. 2022/0216 (COD) - COM(2022) 338 final - 11396/22 + ADD 1-6] (109940/EU XXVII.GP)
06.10.2022	RAT: 13266/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish Parliament (Cortes Generales) (115020/EU XXVII.GP)
11.10.2022	RAT: 13409/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Portuguese Parliament (Assembleia da República) (115576/EU XXVII.GP)
19.10.2022	RAT: 13596/22	EUST	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC [11396/22 - COM(2022) 338 final] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Parliament of the Czech Republic (116744/EU XXVII.GP)

Datum	Dok.Nr.	Art	Betreff
15.07.2022	RAT: 11396/22	EUST	Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und zur Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG (108760/EU XXVII.GP)

Dok.Nr.	Links
COM: COM(2022) 338	EUR-Lex IPEX