Critical Medicines Act
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In interinstitutional negotiations (trilogues). Parliament and Council are working toward a provisional agreement, which would still need formal adoption to become law.
Last active 16 Jun 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal aims to reduce medicine shortages by supporting EU production, coordinated purchasing, and stronger supply chains for critical and hard-to-access medicines.
Who it affects
It affects patients who rely on essential or hard-to-access medicines, pharmaceutical manufacturers, medicine suppliers, and public health systems buying medicines.
Core of the proposal
- Creates “strategic projects” for EU manufacturing of critical medicines, active substances, and key inputs.
- Fast-tracks permits, support, and possible funding for qualifying strategic manufacturing projects.
- Requires public buyers to consider supply resilience, not only price, when buying critical medicines.
- Allows Commission-supported cross-border, joint, or central purchasing for eligible medicines.
Key provisions
- Takes effect
- It enters into force on the twentieth day after publication in the Official Journal; the application date is left blank in the proposal.
Articles changed · 5 across 1 law
- Regulation (EU) 2024/795 (32024R0795)
- art. 2(1)(a)(iii): replaces subparagraph (iii) on biotechnologies and technologies relevant for critical medicines manufacturing
- art. 2(3): adds subparagraph on value chains for critical medicinal products
- art. 2(8): adds paragraph deeming certain Critical Medicines Act strategic projects to contribute to STEP objectives
- art. 4(7): replaces paragraph to include Critical Medicines Act strategic projects in cumulative Union funding rules
- art. 6(1)(c): replaces point to include Critical Medicines Act strategic projects in Sovereignty Portal details
Latest update
06 Jun 2026The most recent development in this bill's progress.
1st reading – European Parliament → Trilogues (interinstitutional negotiations)
1st reading – European Parliament → Trilogues (interinstitutional negotiations)
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker