UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
requirements, as set out in Annex I to EU Directive 2001/83, as amended by Schedule 8B of the HMRs. 3.3 Period of Validity of Marketing Authorisations MAs for medicinal products in the UK are granted by the UK Licensing Authority (comprising Health Min- isters) and are then valid for an initial period of five years. However, an MA ceases to be valid if the prod- uct is not placed on the market within three years of the date of authorisation (a provision known as the “sunset” clause). A renewal application should be submitted to the MHRA six months before expiry of the MA and will be considered on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the MA will be valid for an unlimited period, unless there are justi- fied grounds relating to pharmacovigilance to proceed with one additional five-year renewal. The MHRA may revoke, vary or suspend a UK MA in certain situations, including if the MHRA consid- ers that the product is harmful or that the positive therapeutic effects of the product do not outweigh its risks to the health of patients or the public, or that the product’s composition is not as described in the application for the MA or the material supplied with it. With regard to medical devices, a UK Conformity Assessed (UKCA) mark indicates compliance with the requirements with the UK Medical Devices Regu- lations 2002 It requires conformity assessment by a UK Approved Body (the UK equivalent of an EU Noti- fied Body) for higher-risk devices, The UKCA mark is valid indefinitely unless the specifications of the device change. The MHRA has the power to issue various notices to manufacturers to ban the supply of any goods that are considered unsafe or that do not comply with the UK Medical Devices Regulations. 3.4 Procedure for Obtaining a Marketing Authorisation Medicinal Products An application for a UK national MA must be made to the MHRA and must include the particulars and
research data or justifications for exceptions that are described in the HMRs, which is based on the EU Directive 2001/83. Following Brexit, UK MAs were split into various types, depending on the parts of the UK to which they applied. In particular, applications intended to cover the marketing of a product in North- ern Ireland had to comply with the requirements of EU Directive 2001/83 and EU Regulation 726/2004. How- ever, from January 2025, the Windsor Framework pro- vides that applications for a UK-wide product licence can be made to the MHRA under UK law. Some MAs solely for the market in Northern Ireland continue to be granted based on the requirements of EU legislation. Variations to a marketing authorisation must be sub- mitted to the MHRA, with the required supporting data, following the process in the MHRA’s variation guidance for the appropriate classification: • Type IA: minor, usually administrative, “do and tell” changes. • Type IB: minor changes needing prior assessment. • Type II: major changes significantly affecting qual- ity, safety or efficacy. • Extensions: changes so significant that a new mar- keting authorisation is required. A marketing authorisation may be transferred to a new holder by submitting a Change of Ownership applica- tion (with the prescribed form and supporting docu- ments) to the MHRA. Either the new or old holder may make the application. Medical Devices From 1 January 2021, medical devices may be placed on the Great Britain market, with an accompanying UKCA mark, based on the requirements of the UK Medical Devices Regulations 2002. The EU CE mark- ing will continue to be recognised in Great Britain, and certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market, up to June 2030, with different dates depending on the device. The UK government is currently consult- ing on the indefinite recognition of EU CE marking in Great Britain. EU rules will continue to apply in Northern Ireland, and EU CE marking is required. Where the manufacturer
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