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How the MHRA treats traditional herbal medicines and homeopathic medicines.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
An overview of the legal requirements for children鈥檚 medicines that Marketing Authorisation Holders (MAHs) need to abide by.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
This guidance covers 鈥榞randfathering鈥� and managing the lifecycle changes of medicinal products.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
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.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
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