22 Apr, 2024 Portugal implements Regulation (EU) 2017/745, on Medical Devices By Inês Santana Metello Mariana Ricardo It has been just over three years since the respective notification procedure to the European Commission (reported here), the Portuguese...
08 Jan, 2024 Portugal | Removal of the retail price of medicines from labelling and packaging By Mariana Ricardo Since 2006, when the Medicines Code was approved in Portugal, marketing authorisation holders had to include the retail selling price of...
23 Nov, 2023 UK CMA publishes Competition Law Guidance for Cooperations on Combination Therapies By Alexandra Kamerling Executive Summary Combination therapies involve the use of two or more separate medicines in combination to treat a disease. It can be...
17 Nov, 2023 UK Healthcare Procurement: Provider selection regime regulations overview By Sammi King Saman Anwar Mark Vipan It is currently intended that the Provider Selection Regime (PSR) will come into force on 1 January 2024. The PSR Regulations are a new...
25 Oct, 2023 Artificial Intelligence and healthcare: the Italian DPA adopts a decalogue on GDPR compliance of national healthcare services using AI By Cristina Criscuoli The use of artificial intelligence (‘AI’) systems in the pharmaceutical and healthcare sectors is growing exponentially, with...
06 Oct, 2023 Poland - Life Sciences Monthly Brief, September 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our September monthly briefing for Poland, which covers key updates and insights in the following areas: Medicinal...
29 Aug, 2023 Going green, literally – (slow) legalization of cannabis in Germany By Philip Weyand Guido Kleve Dylan Kennett Cannabis for adult-use is no longer a clandestine indulgence anymore, but a thriving industry in certain countries globally. Germany...
28 Apr, 2023 The UK voluntary scheme for branded medicines pricing and access (VPAS): just what the doctor ordered, or a bitter pill to swallow? By Michael Stead Martha Pownall On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
25 Apr, 2023 The Czech government is planning a regulated cannabis market By Jan Metelka Dylan Kennett The Czech government has announced its plan to introduce a highly regulated cannabis market in the Czech Republic. Currently, cannabis is...
20 Apr, 2023 Cross-border considerations for privacy in clinical trials - At the Intersection of Sciences and Law Podcast Series By James Clark Paula Gonzalez de Castejón Llano-Ponte David Kopans In this episode of At the Intersection of Sciences and Law Podcast Series, in light of the recent publication of our Cross-border Guide...
17 Apr, 2023 Plausibility of inventions: the decision of the EPO Enlarged Board of Appeal in G 2/21 By Massimiliano Tiberio Introduction On March 23rd, 2023, the Enlarged Board of Appeal of the EPO issued the long-awaited decision concerning the concept of...
12 Apr, 2023 The New Italian Public Contracts Code By Giorgia Romitelli Roberta Moffa Anna Mazzoncini Riccardo Scioscia +1 more... Show less As of March 28, The Italian Council of Ministers have approved the new Public Contracts Code. The Legislative Decree No. 36 of March 31,...
11 Apr, 2023 Italy modifies medical device payback system for 2015-2018: Companies have to make quick and important choices By Giorgia Romitelli Giovanni Iaselli Roberta Moffa With Law Decree no. 34/2023, the Italian government has approved significant changes to the Italian medical devices payback system for...
03 Apr, 2023 New Guidance from the Medicines & Healthcare products Regulatory Agency (MHRA) on the Intended Purpose Statement for Medical Device Software By Poppy Williams As part of the MHRA’s Software and AI as a Medical Device Change Programme, the MHRA has recently published guidance on crafting an...
20 Mar, 2023 Extended transition period gives medical device industry extra time to comply with EU MDR By Marco de Morpurgo Nicola Landolfi A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the...
10 Mar, 2023 Poland - Life Sciences monthly brief, February 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Medicinal productsClinical...