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Medicines, medical devices

Guidance and regulation

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  • How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.

  • How to write clear and effective field safety notices (FSNs) for medical devices.

  • Detailing the information you need to provide the MHRA when you notify us of your clinical investigation plans.

  • How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

  • How the MHRA decides whether to approve a clinical investigation for medical devices.

  • How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.

  • How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines

  • Information about ensuring blood and blood component safety.

  • Guidance on the deadlines for initial and response submissions.

  • The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.

  • Information about the MHRA graduate scheme which is currently closed for applications.

  • Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.

  • These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.

  • A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).

  • The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.

  • How to register as a manufacturer, importer or distributor of active substances.

  • The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.

  • Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.

  • Information on comparator products used in studies supporting abridged marketing authorisation application.

  • The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.