Members' Research Service By / June 21, 2023

Revision of EU pharmaceutical legislation [EU Legislation in Progress]

EU policy on pharmaceuticals for human use dates back to 1965 (Council Directive 65/65/EEC). The last major revision took place in 2004 (adoption of Regulation (EC) No 726/2004 and revision of Directive 2001/83/EEC, commonly referred to as the ‘EU general pharmaceutical legislation’).

© okskaz / Adobe Stock

Written by Laurence Amand-Eeckhout (1st edition).

On 26 Avril 2023, the European Commission put forward a ‘pharmaceutical package’ to revise the EU’s pharmaceutical legislation and make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards. The package includes proposals for a new directive and a new regulation, which would replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. The package is completed by a communication and a Council recommendation to step up the fight against antimicrobial resistance. The legislative proposals are now in the hands of the co-legislators.


(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
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)
(B) Monika Beňová (S&D, Slovakia)
(A) Annalisa Tardino (ID, Italy)
(B) Elisabetta De Blasis (ID, Italy)

Renew, Greens/EFA, ECR, The Left –  to be appointed
Ordinary legislative
procedure (COD)
(Parliament and Council
on equal footing – formerly ‘co-decision’)

Next steps expected: Publication of draft reports
EU legislation in progress

Related Articles

Leave a Reply

%d bloggers like this: