backOn April 26, 2023, the European Commission published lengthy legislative proposals (“Revision”) for an updated: (i) Directive on the Union code relating to medicinal products for human use; and (ii) Regulation setting out the centralized procedure and establishing the EMA. If finalized, these proposals will replace the current Directive 2001/83 and Regulation 726/2004, respectively.
This client alert supplies a series of summaries that explain the main changes proposed by the European Commission in the following areas:
- Marketing authorization procedures
- Regulatory exclusivities
- Environmental obligations and risks
- Shortages and critical medicinal products
- Orphan regime
- Pediatric regime
- Specific categories of products such as antimicrobials, ATMPs, and combination products
- Relevant Miscellaneous
King & Spalding’s regulatory Life Sciences lawyers can help you better understand the changes that may result from the Revision, and anticipate their impact on the development and, in the future, marketing of products in Europe.
Companies involved in the development of orphan and pediatric medicinal products, as well as antibiotics, should closely follow future discussions around revision of the legislative framework and, whenever needed, be involved in those discussions.
Companies also should anticipate evolution of the EU legal framework and its impacts on current development and investment.