The EU's revised pharmaceutical legislation

Join us to explore the EU's revised pharmaceutical legislation, unlocking insights into pivotal regulatory changes and sector impacts

03 December 2024

Event

The EU's revised pharmaceutical legislation composes of a Directive and a Regulation proposal, is part of the European Commission's pharmaceutical strategy announced in November 2020, which outlined a series of actions to revise the basic pharmaceutical legislation, including Directive 2001/83/EC and Regulation (EC) No726/2004.

After the publication of the proposed text by the European Commission, the European Parliament, during the April plenary session, adopted a modified version, at first reading for the proposed directive and for the proposed regulation.

To navigate these changes in the version adopted by the Parliament and to understand the next steps, join our conference where our healthcare and life sciences experts dissect the critical topics of this legislative reform and in particular:

  • Regulatory Data Protection and Market Exclusivity Orphan medicinal products
  • Paediatric incentives
  • Advertising
  • Management of medicinal product shortages
  • Package leaflet
  • Environmental consideration
  • Antimicrobials Development and Stewardship
  • Hospital Exemption

This event is designed to provide a comprehensive understanding of the revised legislation's impact on the pharmaceutical sector, from regulatory changes to environmental considerations.

Event details