Medicinal products for human use
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Provisional agreement reached, awaiting formal adoption by Parliament and Council.
Last active 18 Mar 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal rewrites EU rules for human medicines to improve access, supply, innovation, safety oversight, and environmental protection.
Who it affects
It affects patients across the EU, pharmaceutical companies, generic and biosimilar manufacturers, medicine manufacturers and distributors, healthcare systems, and people needing rare-disease or children’s medicines.
Core of the proposal
- Creates variable data-protection incentives for EU-wide launch, unmet medical needs, comparative trials, and new indications.
- Strengthens shortage duties, including earlier notifications and marketing-authorisation transfer offers before withdrawal.
- Expands environmental risk assessment, including antimicrobial-resistance risks across an antimicrobial’s lifecycle.
- Simplifies authorisation rules for generics, biosimilars, electronic submissions, product information, and some post-authorisation procedures.
Key provisions
- Transitional law
- The proposal includes temporary UK-supply derogations for Cyprus, Ireland, Malta and Northern Ireland, and risk-based ERA updates for older authorised medicines.
Articles changed · 2 across 2 laws
- Directive 2001/83/EC (32001L0083)
- entire act: repeals and replaces the existing Community code on medicinal products for human use
- Directive 2009/35/EC (32009L0035)
- entire act: repeals the directive on colouring matters added to medicinal products
Latest update
05 Jun 2026The most recent development in this bill's progress.
Trilogues (interinstitutional negotiations) → Trilogues (interinstitutional negotiations)
Trilogues (interinstitutional negotiations) → Trilogues (interinstitutional negotiations)
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker