Aisling Casey
William Fry
Articles
Court of Appeal Decision Awaited in Biogen Appeal on Interlocutory Injunction
Ireland - January 3 2023 Twomey J delivered his judgment on 26 October 2022. He discharged the interlocutory injunction, and refused Biogen a new injunction in lieu. Judgment…
Court Dismisses Judicial Review of Marketing Authorisation Grant for Falling Outside Time Limits - A Cautionary Note to Pharmaceutical Manufacturers
Ireland - July 7 2022 On 10 May 2022, the Court of Appeal (COA) dismissed an appeal brought by the veterinary pharmaceutical manufacturer, Arthropharm, over the High…
Colette Brady, Imogen Boles Gray, Charleen O’Keeffe, Laura Scott
Guidance Published on Appropriate Surveillance under Article 120 of the MDR
European Union, Ireland - April 28 2022 The Medical Device Coordination Group (MDCG) has published guidance on the activities to be performed by notified bodies as part of their ongoing…
Progressive Roll Out of the IVDR Confirmed by EU Parliament and Council
European Union - January 7 2022 The In Vitro Medical Devices Regulation (Regulation (EU) 2017/746) (IVDR) sets out the new regulatory framework for in vitro diagnostic (IVD) medical…
New Medicines Supply Agreement Confirmed by IPHA
Ireland - December 20 2021 On 15 December, the Irish Pharmaceutical Healthcare Association (IPHA) announced a new four-year Framework Agreement on the Supply and Pricing of…
Colette Brady, Sinéad Cullen, Charleen O’Keeffe, Laura Scott
