28 Oct, 2024 EU Pharmaceutical Reform: Update on the proposed changes to paediatric medicinal product legislation By Phillipus Putter This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
14 Oct, 2024 Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...
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...
05 Sep, 2024 What do the Political Guidelines for the Next European Commission bring to the life sciences & healthcare industry? By Hester Borgers Ana-Maria Barbu-Nyström On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
27 Aug, 2024 Clinical Trial Update in Ireland: New model Clinical Trial Agreement for Tripartite Clinical Trials in Ireland By Kelly Mackey Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
30 Jul, 2024 New UK government’s plans for life sciences: the people and policies explained By Sally Shorthose Heidi Hurdle Charlotte Getz The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
30 Jul, 2024 New Draft Cybersecurity Act in the Netherlands: What you need to know By Wilfred Steenbruggen Puck van den Bosch In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...
18 Jun, 2024 CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body By Andy van Esdonk On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23...
30 Apr, 2024 Developments in the Netherlands on preventing unwanted influence of healthcare professionals by medical companies By Hester Borgers Jephta Zantinge On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...
18 Dec, 2023 The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023 By Sally Shorthose Pieter Erasmus The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
05 Dec, 2023 AI in healthcare: the World Health Organisation’s regulatory considerations By Hester Borgers Dr. Nils Lölfing The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence (AI) for healthcare in October...
28 Sep, 2023 Circular economy: what impact for healthcare players? By Alexandre Vuchot Johanna Harelimana Nour Saab Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...
14 Sep, 2023 EMA’s envisaged risk-based and human-centric approach to regulate AI By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
09 Aug, 2023 EU Commission’s proposed changes to marketing authorisation procedures By Sophie Vo Sally Shorthose This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
26 Jul, 2023 What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines? By Phillipus Putter 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...
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...