MHRA: New Guidance on Marketing Authorisation Renewal Under Windsor Framework

• The MHRA has updated its guidance for renewing marketing authorisations, incorporating new arrangements from the Windsor Framework for human medicines.
• From January 1, 2025, all UK-licensed human medicines will be authorised by the MHRA under national UK requirements, ending automatic EU authorisation in Northern Ireland.
• Products previously under the EU centralised procedure in Northern Ireland will now be classified as "Category 1" and require MHRA UK-wide authorisation.
• Marketing authorisations are typically valid for five years, with renewal applications generally due nine months before expiry, unless using the International Recognition Procedure.
• Renewal submissions to the MHRA must align with current EU content requirements, and authorisations remain valid during the review period.

From January 1, 2025, all human medicines licensed in the UK will be authorised by the Medicines and Healthcare products Regulatory Agency under the Human Medicines Regulations 2012, marking a significant shift in the regulatory landscape.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued revised guidance concerning the renewal of marketing authorisations (MAs) for medicinal products within the United Kingdom. This updated advice is crucial for understanding the evolving regulatory landscape, particularly in light of the Windsor Framework. The new directives supersede previous information related to Brexit, including details on Centrally Authorised Products (CAPs), and now explicitly incorporate the arrangements for human medicines established under the Windsor Framework.

This comprehensive update also introduces specific provisions for handling variations pertaining to newly defined Category 1 and Category 2 products. Furthermore, the guidance provides clarified procedures for Conditional Marketing Authorisations (CMAs) and those products authorised via the International Recognition Procedure (IRP). It also addresses changes to submission requirements for products previously under the Mutual Recognition/Decentralised Procedure (MR/DCP), offering applicants clear advice on leveraging the reliance/recognition procedure for both standard MA renewals and the annual renewal of CMAs.

A pivotal aspect of the revised guidance stems from the Windsor Framework arrangements for human medicines, which are set to take effect from January 1, 2025. This date marks a fundamental shift, as all medicines licensed for use in the UK will henceforth be authorised exclusively by the MHRA, operating under the Human Medicines Regulations 2012. This change signifies the end of the previous system where certain products, specifically those under the EU’s centralised procedure, were automatically granted authorisation in Northern Ireland.

Under the new framework, these previously EU-authorised products will no longer benefit from automatic recognition in Northern Ireland. Instead, they will transition to being authorised UK-wide by the MHRA, adhering to national UK requirements. These specific products will be formally designated as "Category 1 products" under UK law. Conversely, any medicinal products that do not fall within this defined Category 1 will be classified as "Category 2," establishing a clear distinction in the regulatory approach for different types of human medicines within the UK market.

Typically, a marketing authorisation remains valid for a period of five years from its initial authorisation date. Holders of these authorisations are generally required to submit their renewal applications nine months prior to the MA's expiry. An exception to this timeline applies when the application is being processed through the International Recognition Procedure, for which specific guidance is provided. The MHRA continues to facilitate submissions through electronic Application Forms (eAFs) for UK medicines licensing applications, making current eAF forms available for download as an interim measure to ensure business continuity. Importantly, the established submission routes, validation criteria, and assessment processes for these eAFs remain unaltered.

Once a renewal application has been duly submitted, the existing marketing authorisation will continue to be legally effective until the Marketing Authorisation Holder (MAH) receives a formal decision regarding their application. The outcome of a renewal application can vary: an authorisation may be renewed indefinitely, or it may be granted for another five-year term if specific pharmacovigilance grounds necessitate such a limitation. In cases of a five-year renewal due to pharmacovigilance concerns, one subsequent five-year renewal application may be permitted. It is also important to note that the requirements for the content of renewal submissions to the MHRA, for products authorised in the UK, will maintain alignment with the current submission standards observed within the European Union.

Lawyers and compliance officers must understand the updated MHRA guidance on renewing marketing authorisations, particularly the new requirements stemming from the Windsor Framework for human medicines, including the distinction between Category 1 and Category 2 products, to ensure clients' timely and compliant submissions in the UK.

Source: Original reporting via GOV.UK guidance