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How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
List of Field Safety Notices from15 to 19 April 2024.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
A list of authorised orphan medicinal products registered by the UK Licensing Authority.
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
Marketing authorisations granted in 2024
Parallel import licences granted in 2024
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Information about suspected side effects of e-cigarettes and how to report side effects.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
A list of authorised CAP Bridging Mechanism products registered by the UK Licensing Authority.
Information for healthcare professionals and the public on Moderna's bivalent vaccines. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below)
Information for healthcare professionals and the public about the adapted Spikevax XBB.1.5 vaccine
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.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
MHRA performance metrics for clinical trials and established medicines assessment.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
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