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Departments, agencies and public bodies
News stories, speeches, letters and notices
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Consultations and strategy
Data, Freedom of Information releases and corporate reports
Marketing authorisations granted in 2024
Parallel import licences granted in 2024
List of Field Safety Notices from 29 April to 3 May 2024.
A list of authorised orphan medicinal products registered by the UK licensing authority.
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
List of sites granted a manufacturer or wholesale dealer licence
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
A research report on attitudes to digital mental health technology.
The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
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