5/8/2024 10:12:00 AM SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin - interplay with the ATMP Legislation By Marc Martens Lora Arifagic Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...
7/10/2023 9:10:00 PM Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance By Sarah Faircliffe Nour Saab Johanna Harelimana This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
6/27/2023 9:17:00 PM Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation By Anna Koster Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
6/23/2023 9:22:00 PM Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use By Emma Stok Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
4/28/2023 2:15:00 PM Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework By Marc Martens Lora Arifagic Kevin Munungu Lungungu On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of the pharmaceutical legislative...
4/3/2023 10:14:00 AM The Windsor Framework: One Step Closer to a Single UK market By Pieter Erasmus Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this means in practice for the UK...