![Revision of EU pharmaceutical legislation [EU Legislation in Progress]](https://i0.wp.com/epthinktank.eu/wp-content/uploads/2023/06/EPRS-Briefing-749789-Revision-EU-pharmaceutical-legislation-FINAL.png?fit=1024%2C683&ssl=1)
Written by Laurence Amand-Eeckhout (3rd edition, updated on 31.05.2024).
On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU’s pharmaceutical legislation. The revision seeks to enhance the security of supply of medicines, making them more available, accessible and affordable across EU countries, while supporting the attractiveness of the EU pharmaceutical industry by fostering research and innovation. The ‘pharmaceutical package’ includes proposals for a new directive and a new regulation that would replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. The Council has not yet adopted its position.
Complete version
- May 2024: Revision of EU pharmaceutical legislation (3rd edition)
| (A) 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. (B) 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. |
| Committee responsible: | Committee Environment, Public Health & Food Safety (ENVI) | (A) COM(2023) 193 (B) COM(2023) 192 26.4.2023 |
| Rapporteurs: | (A) Tiemo Wölken (S&D, Germany) (B) Pernille Weiss (EPP, Denmark) | (A) 2023/0131(COD) (B) 2023/0132(COD) |
| Shadow rapporteurs: | (A) Tomislav Sokol (EPP, Croatia); Frédérique Ries (Renew, Belgium); Tilly Metz (Greens/EFA, Luxembourg); Elisabetta De Blasis (ID, Italy); Andrey Slabakov (ECR, Bulgaria); Kateřina Konečná (The Left, Czechia) (B) Monika Beňová (S&D, Slovakia); Catherine Almaric (Renew, France); Margrete Auken (Greens/EFA, Denmark); Annalisa Tardino (ID, Italy); Joanna Kopcińska (ECR, Poland); Kateřina Konečná (The Left, Czechia) | Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’) |
| Next steps expected: Trilogue negotiations |
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