UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
be able to show a sufficient interest in the matter to which the application relates. The grounds for judicial review may be summarised as: • illegality; • irrationality; • procedural unfairness; and • legitimate expectation. 1.3 Categories of Pharmaceuticals and There are three legal classifications of medicinal prod- ucts, each of which determines the level of control over their supply: • prescription-only medicines (POMs) – these have to be prescribed by a doctor or other authorised healthcare professional (HCP) and have to be dispensed from a pharmacy or another specifically licensed place; • pharmacy (also known as P) – these have an intermediate level of control and, while they are available over the counter or OTC, they can be purchased only from pharmacies and under a phar- macist’s supervision; and Medical Devices Medicinal Products • general sales list (GSL) – these medicines are also categorised as OTC, but may be bought from gen- eral retail stores or vending machines. Medical Devices Medical devices are classified based on the level of risk associated with their use. The classification relates to the regulatory pathway for the product rather than the conditions of supply, including factors such as: • the intended purpose of the device; • how long it is intended to be in use; and • if the device is invasive/surgically invasive, implant- able or active, or contains a substance which in its own right is considered to be a medicinal sub- stance. General medical devices and active implantable devices fall within the following categories:
• Class I – low risk; • Class IIa – medium risk; • Class IIb – medium risk; and • Class III – high risk.
In vitro diagnostic (IVD) medical devices in Great Brit- ain are currently categorised within four main groups. Those: • considered as general IVD medical devices; • within the classifications stated in Annex II List A of the IVDD (which is referred to in UK legislation); • within the classifications stated in Annex II List B of the IVDD; and • for “self-test” intended to be used by a person at home. There are different classifications under the EU IVDR that applies in Northern Ireland. Clinical trials of medicinal products in the UK are regu- lated by the Medicines for Human Use (Clinical Tri- als) Regulations 2004/1031, which transposed the EU Clinical Trials Directive 2001/20/EC into UK law, and which have been amended to reflect the UK’s with- drawal from the EU. Clinical trials must be conducted in accordance with good clinical practice (GCP), the terms of the approved protocol, clinical trial authorisa- tion and research ethics committee (REC) approval. The EU Clinical Trials Regulation 536/2014, which came into full effect on 31 January 2022, does not apply in Great Britain but, as a result of the Northern Ireland Protocol, certain parts apply in Northern Ire- land. 2. Clinical Trials 2.1 Regulation of Clinical Trials Amendments to the 2004 Regulations, effected through the Medicines for Human Use (Clinical Tri- als) (Amendment) Regulations 2024, will come into force on 28 April 2026. These reforms are intended to streamline clinical trial approvals, enable innova- tion, enhance clinical trial transparency, enable greater risk proportionality, and promote patient and public involvement.
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