Following revisions implementing the political agreement between the Council of the European Union (Council) and the European Parliament (Parliament) of December last year, the two key legislative proposals of the EU pharmaceutical package received the final sign-off from the Council’s COREPER I Committee today.

Attached are copies of the approved proposals, as obtained by Politico:

1. proposal for a Directive on the Union code relating to medicinal products for human use; and
2. proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency.

Politico reports that the Committee on Public Health (SANT) of the Parliament is expected to vote on the proposals on 18 March 2026. If approved, the proposals will be translated into all EU languages and, subsequently, be formally adopted by the Council and the Parliament. Both votes are currently expected to take place in the fall.

The pharmaceutical package was proposed by the European Commission (Commission) in April 2023 (see, Van Bael & Bellis Life Sciences News & Insights of 3 May 2023) and is the first major revision of EU pharmaceutical legislation since 2004.

It significantly revises the regulatory framework in matters as diverse as environmental protection, incentives for developing new antibiotics (transferable exclusivity voucher), labelling, market access and regulatory data protection and shortages. We will address some of the key changes in future editions of this news alert.

The new Directive and Regulation will be complemented by around 100 implementing and delegated acts, which are still to be developed by the Commission.