The EU “Pharma Package” is the most substantial overhaul of medicines legislation in more than 20 years. The political agreement reached on 11 December 2025 confirms the baseline protection model with capped extensions, a broadened Bolar exemption enabling full “day-one” readiness, including participation in procurement tenders, and strengthened supply security obligations. Although formal adoption and national transposition are still pending, the legislative objective is clear: to establish streamlined pathways for immediate post-exclusivity market entry, coupled with enhanced obligations to prevent and manage shortages.
When: 12 February, 16:30
Where: One Gallery., Dyakon Ignatiy 1A
How is this reshaping market entry dynamics, shortage obligations, and regulatory procedures in ways that affect the generics and biosimilars sector?
Join Schönherr for a focused discussion and practical takeaways.
Reserve your place by emailing office.bulgaria@schoenherr.eu or yo.pencheva@schoenherr.eu and receive a complimentary report covering all the topics.
