Renewing marketing authorisations for medicines

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance for renewing marketing authorisations (MAs) following the implementation of the Windsor Framework. Effective January 1, 2025, all human medicines in the UK will be authorised by the MHRA under the Human Medicines Regulations 2012. This transition shifts products previously managed under the EU’s centralised procedure to a UK-wide national system. Products are now classified as Category 1 (formerly EU-centralised) or Category 2. Standard MAs require renewal every five years, with applications generally due nine months before expiration. Conditional MAs must be renewed annually, with submissions due six months prior. Under the new framework, Category 1 renewals will align with EU submission requirements, while Category 2 renewals will follow mutual recognition procedures. In many cases, Category 2 submissions can be simplified to a cover letter and application form, provided there are no changes to the product’s benefit-risk profile. The guidance also details the International Recognition Procedure (IRP), allowing companies to align UK renewals with decisions from reference regulators, provided they submit to the MHRA within 60 days of the external decision. Companies must immediately report any safety concerns identified by reference regulators and are responsible for ensuring all product information remains scientifically current. Fees apply for renewals involving new active substances.