EU Pharma Package: Final Texts officially published

The Committee of Permanent Representatives of the EU Member States (COREPER I) has approved the trilogue outcome reached in December 2025. The final texts have now been officially published:

• The new 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 
• The new 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 

The European Parliament's SANT Committee will vote on both texts on 18 March 2026. This is a formal but politically relevant intermediate stage. This will be followed by final approval by the EU Parliament and Council, and translation into all EU languages, publication in the Official Journal and then entry into force with corresponding transition periods.

Numbering: COD numbers must not change during the legislative process. They are assigned once at the beginning and do not change (2023/0132 (COD) for the directive and 2023/0131 (COD) for the regulation). However, the final legal acts adopted at the end of the procedure will be given their own new EU numbers, for example: Directive (EU) 2026/XYZ or Regulation (EU) 2026/XYZ.
These new numbers then replace the old legal acts (2001/83/EC and 726/2004/EC), with the original COD number continuing to serve as a reference.

This new pharmaceutical legislation represents the most significant revision of the legal framework in over two decades. It aims to modernise the development, authorisation and supply of medicines to patients across the EU.

At the beginning of the year, the European Medicines Agency (EMA) set up a website dedicated to the implementation of the reform of EU pharmaceutical legislation. The newly created website serves as a central source of information for all EMA stakeholders and provides up-to-date guidance and resources. It highlights the key benefits of the new medicines legislation and, once the new legislative text is adopted in 2026, will provide detailed insights into the implementation process for specific technical and procedural aspects.

ECA is organising a live online seminar (in English) on 17 March with an overview and focus on GMP-relevant changes.