A path towards a crisis-proof EU pharmaceutical legislation? The European Commission proposal, MIP 2023

On April 27 2023, the European Commission presented a proposal for the reform of the general pharmaceutical legislation in the EU. The proposal is based on the Pharmaceutical Strategy for Europe and is divided into a Directive on the creation of an EU code for medicinal products for human use and a proposal for a Regulation establishing EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules for the European Medicines Agency. In her contribution, Dr Gisela Grabow not only deals with the possible changes, but also with the most important questions that arise for those affected.