UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
Arnold & Porter Tower 42 25 Old Broad Street London EC2N 1HQ UK
Tel: +44 20 7786 6100 Fax: +44 20 7786 6299 Email: adela.williams@arnoldporter.com Web: www.arnoldporter.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The regulatory authority with statutory responsibility for the application and enforcement of laws concern- ing pharmaceuticals and medical devices in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency sponsored by the Department of Health and Social Care (DHSC). UK regulation of medicinal products derives from EU legislation implemented prior to the withdrawal of the UK from the EU. Following Brexit, the UK is no longer subject to EU single market rules or EU law; however, under the EU–UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, Northern Ireland continues to follow EU rules. The arrangements for supply of medicinal products in Northern Ireland were simplified as a result of the EU-UK Windsor Frame- work which entered into force on 1 January 2025 and provides for the grant of UK-wide authorisations for medicines, pursuant to domestic legislation. Pre-existing domestic legislation that implemented EU law continues to have effect in the UK. The regu- latory framework for medicinal products is therefore based principally on Directive 2001/83/EC and Regu- lation (EC) 726/2004. The key UK legislation is the Human Medicines Regulations 2012 (SI 2012/1916), as amended (HMRs). Similarly, UK regulation of medical devices derives from three EU Directives (the Medical Device Direc- tives):
• Council Directive 93/42/EEC on Medical Devices; • Council Directive 90/385/EEC on Active Implant- able Medical Devices; and • Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD). These Directives are implemented in UK domestic law through the Medical Devices Regulations 2002/618, as amended (the “UK Medical Devices Regulations”). The more recent EU Regulations on medical devices, Regulation (EU) 2017/745 on medical devices (EU MDR) and Regulation (EU) 2017/746 on in vitro diag- nostic medical devices (EU IVDR), do not apply to Great Britain, but do apply in Northern Ireland. The UK government intends to bring the UK Medical Devices Regulations up to date through a series of statutory instruments. The first of these regarding post-market surveillance requirements came into force on 16 June 2025 (Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regula- tions 2024). 1.2 Challenging Decisions of Regulatory Bodies Decisions of the MHRA may be challenged by way of judicial review in the Administrative Court, King’s Bench Division or through statutory review proceed- ings, although this is rarely used. An application for judicial review must be made promptly, and in any event within three months of the decision to be challenged, and the court’s permission is required to proceed with a claim. Applicants must
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