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: SEC(2023) 390 PUBLIC
29.11.2022
englisch

EU-V: Empfehlungen und Stellungnahmen

Regulatory Scrutiny Board Opinions/Revision of the general pharmaceutical legislation/Revision of the EU legislation on medicines for children and rare diseases

Erstellt am 29.11.2022

Eingelangt am 26.04.2023, Europäische Kommission - Österr. Parlament

  • COM: SEC(2023) 390 final PDF

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Linkart Link
RIL
2001/83/EC
VER
141/2000
VER
1901/2006
VER
726/2004
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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: 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)
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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: 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)
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: 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)
Dok.Nr.
Links
COM: SEC(2023) 390 EUR-Lex IPEX