Medicines: apply for a variation to your marketing authorisation

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions. Get emails about this page Print this page Overview Variations are either: an administrative change such as a change of company name and/or address a change to the characteristics of a product that can affect its quality, such as a change to its composition, method of manufacture or how it is tested a change which may affect the safety, efficacy or pharmacovigilance requirements of the product Changes are classed as major (Type II) or minor. Minor changes are either Type IA or IB. These classifications are explained further in the minor variations and major variations sections. Applicants can apply for: a single change to one marketing authorisation ( MA ) multiple changes to one or more MAs (refer to the section on submitting multiple changes) From 1 January 2025, the following marketing authorisation ( MA ) types are available in the United Kingdom (UK): UK-wide MA – these products are authorised for sale and supply throughout the United Kingdom as a purely national UK-wide MA regardless of the route of application: direct national, International Recognition Procedure (IRP), Project Orbis, Access. as a UK-wide MA that was granted as part of a Mutual Recognition/Decentralised (MR/DC) procedure involving UK as Concerned Member state ( CMS ) before 1 January 2021. The MA holder has the option to continue to manage the MA in line with the MR/DC procedure with Northern Ireland (NI) remaining as a CMS . Note that UK-wide MAs can no longer be applied for through EU procedures. NI Only MAs (PLNI) – these products are authorised for sale and supply in Northern Ireland only as part of an MR/DC procedure including Northern Ireland only as a concerned member state ( CMS ). Centralised marketing authorisations and subsequent variations ceased to have validity in Northern Ireland from 1 January 2025. For further information on these authorisation types refer to guidance on UK-Wide Licensing of Medicines . The procedures detailed under Chapter IIa of the EU Variations Regulation (EC) No 1234/2008 regarding variations to the terms of marketing authorisations for medicinal products for human use, which applies to variations to purely national marketing authorisations in the European union (EU), were incorporated into UK law on 31 December 2020. They continue to apply to variations to purely national UK marketing authorisations as set out in regulation 65C and Schedule 10A to the Human Medicines Regulations 2012 (as amended) “the HMRs”. Commission Regulation 2024/1701 of 11 March 2024 amending the Variations Regulation (EC) No 1234/2008, has also been implemented in the UK. It entered into force on 7 July 2024 and became applicable on 1 January 2025. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401701 Subsequent to that revision of the Variation Regulation applicable since 1 January 2025, the European Commission (EC) has published a communication which sets out guidance on the various categories of variations and operation of the procedures (Communication 2025/5045 dated 22 September 2025): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045 The new guidance on procedures and categories of variations applies from 15 January 2026. The application procedure which will be followed for the different types of UK marketing authorisations from 1 January 2025 is dependent on the regulatory authority responsible for leading the assessment: Therefore,