UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
mission to the UK, Australia, Canada, Singapore and/ or Switzerland, for an internationally co-ordinated review. The standard procedure takes up to 210 days (excluding stop-clocks). In addition, the Innovative Licensing and Access Path- way (ILAP) is an initiative aimed at bringing innova- tive medicines and medicine-device combinations to the UK market more quickly. Successful applicants are awarded an Innovation Passport, which enables developers to work collaboratively with various part- ners, including the national health services (NHS), MHRA, and UK Health Technology Assessment (HTA) bodies to accelerate the time to patient care for In relation to medical devices, the UK has launched the Innovative Devices Access Pathway (IDAP) pilot that is designed to accelerate the development of innovative medical devices that meet an unmet clini- cal need in the NHS and support their integration into the UK market. Eight technologies were selected that will receive tailored regulatory and access support. 4.2 Regulatory Reliance On 1 January 2024, an International Recognition Pro- cedure (IRP) for medicinal products came into force in the UK, which enables the MHRA to consider the expertise of “reference regulators” in certain other countries (Australia, Canada, EU/EEA, Japan, Singa- pore, Switzerland and USA) and utilise pre-existing approvals to speed up authorisation in the UK. To be eligible for the IRP route, the product must be clas- sified as a medicinal product in accordance with the HMRs and the IRP application must relate to the same product for which authorisation has already been granted by an RR. The IRP can be used for multi- ple types of MA applications, including chemical and biological new active substances, known active sub- stances, generics, hybrids, biosimilars and new fixed combination products. There are two recognition routes under the IRP: Rec- ognition A (60-day timetable) and Recognition B (110-day timetable), to which different eligibility cri- teria apply. The main criteria for Recognition A are that the RR approval was granted within the previous selected products. Medical Devices
two years and manufacturing processes are the same, with evidence of GMP compliance. For Recognition B, possible applicable criteria are more numerous, but the main criterion is that the RR approval has been granted in the previous ten years, subject to excep- tional circumstances. While MHRA will conduct a tar- geted assessment of IRP applications based on the assessment by the RR, it may reject applications on the basis that evidence supplied by the applicant is not sufficiently robust. For medical devices, as discussed in 3.4 Procedure for Obtaining a Marketing Authorisation , EU CE marks are currently recognised in Great Britain until 30 June 2030 at the latest depending upon the type of device and MHRA is consulting on potential continu- ation of this arrangement indefinitely. In 2024, the MHRA published a statement of policy intent for international recognition of medical devices, which was most recently updated in December 2025. This describes the MHRA’s intentions for recognition by the UK of international regulators’ approvals for medical devices, including, initially, Australia, Canada and the USA, as well as the EU, subject to meeting various criteria. The proposed framework would pro- vide a certificate of international recognition that will grant devices access to the Great Britain market. It is anticipated that certain devices, for example custom- made and certain software devices, will be excluded from eligibility. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants A manufacturer’s licence issued by the MHRA is required in order to manufacture, assemble or import licensed, unlicensed or investigational medicinal products. The process involves the submission of an application and the inspection of the designated manufacturing site by the MHRA to verify compliance with good manufacturing practice (GMP). A manufac- turer’s licence remains in force until it is revoked or surrendered.
394 CHAMBERS.COM
Powered by FlippingBook