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Territory – United Kingom
Medicines and Healthcare products Regulatory Agency (MHRA)
Language – English
- About MHRA
- All MHRA services and information
- Marketing authorisations and licensing guidance
- Product information about medicines
- Medical devices regulation and safety
- Export medical devices
- Register medical devices to place on the market
- Medical devices: guidance for manufacturers on vigilance Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA
- Orphan registered medicinal products – A list of authorised orphan medicinal products registered by the UK Licensing Authority.
- Medicines and Healthcare products Regulatory Agency – Social media use – MHRA social media community guidelines.
- CE marking recognition for medical devices and in vitro diagnostics The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
- Field Safety Notices: 24 to 28 July 2023Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 2023
- Updated: 1 August 2023
- The Windsor Framework – further detail and publicationsFurther detail on the arrangements giving effect to the Windsor Framework.
- Updated: 28 July 2023
- Labelling and packaging of medicinal products for human use following agreement of the Windsor FrameworkInformation on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
- Updated: 28 July 2023
- Renewing Marketing Authorisations for medicines How to renew marketing authorisations for products granted through different routes and at different times.
- Updated: 28 July 2023
- Implementation of medical devices future regime We are aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.
- Software and Artificial Intelligence (AI) as a Medical Device Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
- MHRA: policy for handling conflicts of interest Information about how we handle potential conflicts of interest (COI) between MHRA, NIBSC and CPRD.
- Marketing authorisations granted in 2023 Marketing authorisations granted in 2023