EU Pharma Package: Key Legal And Practical Implications For Malta's Pharmaceutical Sector

The European Union is on the cusp of enacting its most significant overhaul of pharmaceutical legislation in over two decades. The proposed EU Pharma Package, introduced by the European Commission in April 2023, is currently advancing through the legislative process and is expected to come into force between 2026 and 2028. This reform will have far-reaching consequences for all stakeholders in the pharmaceutical sector, including those operating in Malta.

Overview and Objectives

The Pharma Package comprises a new Directive and Regulation, which together will replace the existing general pharmaceutical legislation, including rules on medicines for children and rare diseases. The reform aims to modernise the EU's approach to medicines, with a focus on: