11 Sep, 2024 EU Pharmaceutical Reform: Update on the proposed changes to marketing authorisation procedures By Sally Shorthose Sophie Vo This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
24 Nov, 2023 Polish government, business associations respond to EU pharmaceutical law reform By Andrzej Stelmachowski Following the EC’s announcement of the European Pharmaceutical Strategy[1], the Polish government and the country’s business associations...
27 Sep, 2023 Public Procurement for Biological Medicines in Belgium By Lora Arifagic Marc Martens Introduction The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care...
10 Jul, 2023 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...
27 Jun, 2023 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...
23 Jun, 2023 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...
31 Jan, 2023 Guide to EU and UK Pharmaceutical Regulatory Law 2023 By Sally Shorthose Eighth Edition, Edited by Sally Shorthose The Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides...