Medicines: apply for a variation to your marketing authorisation

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

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.

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.