Article
The EU Pharma Package: Upcoming Reform Of Regulatory Data Exclusivity And Market Protection For Approved Medicines For Human Use
The European Parliament and Council have agreed on the most significant reform of EU pharmaceutical legislation in two decades, fundamentally restructuring the regulatory data exclusivity and market protection framework for newly approved medicines. While the baseline eight-year data protection period remains unchanged, the market exclusivity system has been overhauled with a new modulated approach that reduces automatic protection and requires pharmaceutical companies to complete specific clinical studies

Penningtons Manches Cooper LLP




