Quo vadis Arzneimittelrecht – ein Überblick zur Überarbeitung der EU-Arzneimittelvorschriften, PharmR 6/2023

On April 27, 2023, the EU Commission presented a proposal for the reform of the pharmaceutical legislation in the EU. The proposal would lead to broad and far-reaching changes to the Regulation and the Directive, providing, for example for variable protection periods (standard and conditional periods), a balance between innovation protection and rapid access to medicines, as well as provisions on the early notification of supply shortages and the introduction of the ERA. The article published in PharmR 6/2023 by Dr Marco Stief and Dr Gisela Grabow is intended to shed light on some central issues relevant to market access (data protection, marketing protection, bolar exemption, vouchers) and marketing of medicinal products.