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EU Pharmaceutical Legislation Improves Medicine Access

The EU Commission, Council, and Parliament reached a political agreement on a major reform of EU pharmaceutical legislation on December 11, 2025. The new rules aim to improve equitable access to medicines across the EU/EEA, strengthen supply chain security, and boost Europe's competitiveness through modified market protection rules. Key changes include reduced market protection (one year down from two), maintained eight-year data protection baseline, new transferable exclusivity vouchers for antibiotic development, and stricter environmental requirements for pharmaceutical manufacturing. Assessment timelines for new marketing authorisations are reduced to 180 days.

Nordic Language Pilot Expands to 49 Substances, 19 Medicines Approved

The Nordic language pilot for English-language hospital medicine packages has expanded to 49 active substances, up from 20 when launched on January 1, 2025, with 19 medicines now approved for use across two or more participating countries. NOMA reports positive response from marketing authorisation holders, with applications encouraged for eligible products. The initiative aims to strengthen supply security and availability for low-volume essential hospital products across Denmark, Finland, Iceland, Norway, and Sweden.

Norway RMS DCP Slots Fully Allocated for 2026

The Norwegian Medical Products Agency (NOMA) has announced that all Reference Member State (RMS) slots for decentralised procedure (DCP) assessment of human medicinal products for 2026 have been fully allocated. Requests received after 5 March 2026 will not be considered. Exceptions may be made for medicinal products of significant public health importance, particularly those on the announced list of needed products. NOMA will begin accepting requests for 2027 RMS DCP slots from the fourth quarter of 2026. This notice does not apply to veterinary DCP applications.