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Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Information relating to the disapplication of falsified medicines under UK Law.
Industry must notify the MHRA if they will not be using these flexibilities
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
How to use RamaXL, including system availability, running reports and how to subscribe.
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
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