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) 191 PUBLIC
26.04.2023
englisch

EU-V: Berichte u. Beratungsergebnisse

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

Erstellt am 26.04.2023

Eingelangt am 26.04.2023, Europäische Kommission - Österr. Parlament

COM: SWD(2023) 191 final PDF

Linkart	Link
COM	COM(2023) 192
COM	SEC(2023) 390
COM	SWD(2023) 192
COM	SWD(2023) 193
RIL	2001/83/EC
RIL	2009/35/EC
VER	1901/2006
VER	2001/83

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: 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) 192	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) 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) 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) 192	EUB	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)
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
26.04.2023	RAT: 8417/23	EUST	Vorschlag für eine EMPFEHLUNG DES RATES zur Intensivierung der EU-Maßnahmen zur Bekämpfung antimikrobieller Resistenzen im Rahmen des Konzepts „Eine Gesundheit“ (138861/EU XXVII.GP)
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)