How to renew marketing authorisations for products granted through different routes and at different times.
1. Overview
This guidance provides information on how to renew marketing authorisations (MA) for products granted through different routes in the UK following the agreement of the Windsor Framework arrangements for human medicines. It also includes guidance for 5-year renewal of full authorisation and the annual renewal of a conditional marketing authorisation (CMA).
The Medicines and Healthcare products Regulatory Agency (MHRA) acts as the regulator for products placed on the market in Northern Ireland (NI). There are some different requirements for products placed on the market in the UK with respect to Great Britain (England, Scotland, Wales) and Northern Ireland.
New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework. From that date all medicines licensed in the UK will be authorised by the MHRA under the Human Medicines Regulations 2012.
Products that fall under the EU’s centralised procedure that were previously automatically granted by the EU in NI (as a centrally authorised product (CAP)) will no longer be authorised in this manner. Instead, these products will be authorised UK-wide under national UK requirements by the MHRA. These products will be known as category 1 products under UK law. Products which do not fall under this category will be known as category 2.
2. Renewal of a marketing authorisation
An MA will be valid for 5 years from the date of authorisation and market authorisation holders (MAH) should continue to submit renewal applications 9 months before expiry, unless the application is being submitted via the International Recognition Procedure (IRP). For advice on this procedure please see below, together with further guidance on International Recognition Procedure.
The MHRA continues to accept electronic Application Forms (eAFs) for UK medicines licensing applications. As an interim business continuity measure, MHRA is making the current eAF forms available for applicants to download and use. Existing submission routes, validation requirements and assessment processes remain unchanged.
Once an application has been submitted for renewal, the authorisation will remain in force until the MAH is informed of the decision on the application.
The authorisation may be renewed for an unlimited period or, where there are pharmacovigilance grounds which require it, for a period of 5 years, after which one further renewal application may be made.
The requirements for the content renewal submissions to the MHRA for products authorised in the UK will remain aligned with current EU submission requirements, dependent on the route of authorisation, as detailed below.
2.1 Renewal of MAs for category 1 products
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗