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Information about how approved bodies help regulate medical devices and how to apply for approval.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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 the MHRA treats traditional herbal medicines and homeopathic medicines.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Information relating to the disapplication of falsified medicines under UK Law.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
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).
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.
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