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Patient safety

Guidance and regulation

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  • Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.

  • How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.

  • How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.

  • Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.

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

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

  • How mental health practitioners can manage risk including self-harm and harm to others.

  • Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.

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

  • How to submit a notification of intent to import an unlicensed medicine to the MHRA.

  • Information on the safety of transplanting human organs, tissues and cells from the advisory committee on the Safety of Blood, Tissues and Organs (SaBTO).

  • How to manage medical devices used in health and social care services.

  • How to comply with the regulatory requirements for manufacturing custom-made medical devices.

  • Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.

  • How to join the phase I accreditation scheme.

  • Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).

  • Information about ensuring blood and blood component safety.

  • Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

  • Information to help all NHS staff and allied healthcare partners in their response to victims of domestic violence and abuse.

  • How the death certification process in England and Wales will change from 9 September 2024, including the introduction of medical examiners.