Commission Staff Working Document/Impact Assessment Report/Accompanying the documents 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 and 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 (138824/EU XXVII.GP)

COM: SWD(2023) 192 PUBLIC
26.04.2023
englisch

EU-V: Berichte u. Beratungsergebnisse

Commission Staff Working Document/Impact Assessment Report/Accompanying the documents 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 and 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

Erstellt am 26.04.2023

Eingelangt am 26.04.2023, Europäische Kommission - Österr. Parlament

COM: SWD(2023) 192 final PDF

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COM	COM (2019) 640
COM	COM(2014) 188
COM	COM(2017) 626
COM	COM(2019) 128
COM	COM(2020) 66
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COM	COM(2020) 724
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COM	COM(2021) 350
COM	COM(2021) 497
COM	COM/2021/400
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COM	COM(2022) 197
COM	COM(2023) 192
COM	COM(2023) 193
COM	SEC(2023) 390
COM	SWD(2012) 29
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COM	SWD(2021) 351
COM	SWD(2022) 131
COM	SWD(2023) 191
COM	SWD(2023) 193
EGH	Case T-140/12
INT	2016/2057 (INI)
INT	2020/2071 (INI)
RMA	A 1
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ABL	OJ L 102, 7.4.2004, p. 48
ABL	OJ L 107, 10.4.2014, p. 1
ABL	OJ L 117, 5.5.2017, p. 1
ABL	OJ L 117, 5.5.2017, p. 176
ABL	OJ L 135, 30.5.1991, p. 40
ABL	OJ L 152, 16.6.2009, p. 1
ABL	OJ L 153, 11.6.2019, p. 1
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ABL	OJ L 189, 27.6.2014, p. 112
ABL	OJ L 20, 31.1.2022, p. 1
ABL	OJ L 299, 27.10.2012, p. 1
ABL	OJ L 311, 28.11.2001
ABL	OJ L 321, 10.12.2007, p. 121
ABL	OJ L 327, 22.12.2000
ABL	OJ L 33, 8.2.2003, p. 30
ABL	OJ L 334, 12.12.2008, p. 7
ABL	OJ L 334, 17.12.2010, p. 17
ABL	OJ L 348, 31.12.2010, p. 74
ABL	OJ L 35, 15.2.1995, p. 1
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ABL	OJ L 40, 11.2.89, p. 8
ABL	OJ L 458, 22.12.2021, p. 1
ABL	OJ L136, 30.4.2004
ABL	OJ L427, 30.11.2021, p. 17
BES	2010/227/EU
BES	2014/286/EU
BES	2014/287/EU
BES	2021/2282
EMP	2003/361
RIL	2001/20/EC
RIL	2001/83/EC
RIL	2002/98/EC
RIL	2004/23/EC
RIL	2004/27/EC
RIL	2009/35/EC
RIL	2010/75/EU
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RIL	2011/24/EU
RIL	2011/62/EU
RIL	2012/26/EU
RIL	89/105/EEC
RIL	90/385/EEC
RIL	91/271/EEC
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VER	1223/2009
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Dok.Nr.	Betreff
COM: COM(2023) 192	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 (Text with EEA relevance) (138821/EU XXVII.GP)
COM: COM(2023) 193	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 (Text with EEA relevance) (138819/EU XXVII.GP)
COM: SEC(2023) 390	Regulatory Scrutiny Board Opinions/Revision of the general pharmaceutical legislation/Revision of the EU legislation on medicines for children and rare diseases (138822/EU XXVII.GP)
COM: SWD(2023) 191	Commission Staff Working Document/Subsidiarity Grid/Accompanying the document 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 (138825/EU XXVII.GP)
COM: SWD(2023) 193	Commission Staff Working Document/Executive Summary of the Impact Assessment Report/Accompanying the documents 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 and 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 (138823/EU XXVII.GP)

Thema
Gesundheitswesen
Verbraucher- und Lebensmittelsicherheit

Datum	Dok.Nr.	Art	Betreff
26.04.2023	COM: COM(2023) 193	EUVE	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 (Text with EEA relevance) (138819/EU XXVII.GP)
29.11.2022	COM: SEC(2023) 390	EUES	Regulatory Scrutiny Board Opinions/Revision of the general pharmaceutical legislation/Revision of the EU legislation on medicines for children and rare diseases (138822/EU XXVII.GP)
26.04.2023	COM: SWD(2023) 191	EUB	Commission Staff Working Document/Subsidiarity Grid/Accompanying the document 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 (138825/EU XXVII.GP)
26.04.2023	COM: SWD(2023) 194	EUB	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 (138820/EU XXVII.GP)
26.04.2023	COM: COM(2023) 192	EURE	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 (Text with EEA relevance) (138821/EU XXVII.GP)
26.04.2023	COM: SWD(2023) 193	EUB	Commission Staff Working Document/Executive Summary of the Impact Assessment Report/Accompanying the documents 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 and 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 (138823/EU XXVII.GP)

Datum	Dok.Nr.	Art	Betreff
28.04.2023	RAT: 8759/23	EUST	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 (139088/EU XXVII.GP)