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)

COM: SWD(2023) 194 PUBLIC
26.04.2023
englisch

EU-V: Berichte u. Beratungsergebnisse

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

Erstellt am 26.04.2023

Eingelangt am 26.04.2023, Europäische Kommission - Österr. Parlament

  • COM: SWD(2023) 194 final PDF

 Aufklappen
Linkart Link
COM
COM(2023) 193
COM
SEC(2023) 390
COM
SWD(2023) 192
COM
SWD(2023) 193
VER
1394/2007
VER
141/2000
VER
1901/2006
VER
536/2014
VER
726/2004
 Aufklappen
Dok.Nr.
Betreff
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) 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)
 Aufklappen
 Aufklappen
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)
 Aufklappen
Datum Dok.Nr.
Art Betreff
28.04.2023 RAT: 8758/23 EUST
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)