EU Pharma Package

With the EU Pharmaceutical Package, the European Commission is presenting the most comprehensive reform of European pharmaceutical legislation in over twenty years. The reform aims, in particular, to promote innovation, strengthen the security of supply and modernise the legal framework. The existing provisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 are to be replaced, whilst the special provisions for orphan drugs and paediatric medicines are to be integrated.

In our blog series, we analyse the key elements of the EU Pharmaceutical Package from a practical perspective – from protection periods and market access through regulatory requirements and compliance obligations to procedures and governance. In doing so, we highlight specific areas for action, as well as the timetable, transition periods and implementation steps.