On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published
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Parallel imports: identicality of products when repackaging
On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer…
Evaluation of New Active Substance Status for Biological Products in the EU
On 18 November 2022, the European Medicines Agency (EMA) published a draft reflection paper (Paper) for public consultation on the criteria for the evaluation of new active substance (NAS) status for biological substances. The Paper provides guidance for applicants on…
Delay to EU MDR is on the horizon
It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the…
The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues
Synopsis
On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards…
Demystifying the UPC and the Unitary Patent – answers to some common questions
The Unified Patent Court (UPC) and the unitary patent system are expected to commence on 1 June 2023. Until early December 2022, the UPC was advocating 1 April 2023 as the date of entry into force of the Agreement on a Unified…
Adoption of New Procurement Regulations in the UK
The procurement landscape in the UK is due to change next year. A draft procurement bill (Bill) seeks to consolidate a number of different procurement regulations that originate from EU legislation, including the Public Contracts Regulations 2015 (PCR), into a…
Virtual and Digital Health Digest
Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and…
Latest on software and AI devices from the MHRA
The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates…
ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry
The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member…