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A list of authorised orphan medicinal products registered by the UK Licensing Authority.
Orphan registered products are listed in alphabetical order by trade name.…
A list of orphan authorisations previously registered by the UK Licensing…
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
BSI Assurance UK Ltd (0086) BSI Assurance UK Ltd Kitemark Court Davy…
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.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months af…
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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