Overview
- EU Parliament and Council negotiators reached a political deal to require digital access to package information, typically via a QR code, with paper leaflets retained for now.
- Member states may move to digital-only leaflets, with pharmacies providing free printed versions on request, and Germany currently plans to keep paper inserts.
- The reform mandates specific warnings on antibiotics to address resistance driven by overuse.
- To spur antibiotic development, companies that bring a new antibiotic to market may extend the patent of another in-house medicine by one year.
- Manufacturers must notify authorities six months before a potential supply stop, and the rules are expected to take effect from 2028 after formal approval.