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Guidance and regulation

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  • Blue Guide: advertising and promoting medicines

    Detailed guidance on advertising and promoting medicines.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • In vitro diagnostic medical devices: guidance on legislation

    Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Register of brokers authorised to deal in human medicines

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Advertise your medicines

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Herbal medicines granted a traditional herbal registration (THR)

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Safeguarding Adults: The role of health services

    These documents remind health services of their duties to safeguard adults.

    • From: Department of Health and Social Care
    • Updated:
  • Register a homeopathic medicine

    Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Managing medical devices

    Guidance for healthcare and social services organisations on managing medical devices in practice.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • SaBTO microbiological safety guidelines

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

    • From: Department of Health and Social Care
    • Updated:
  • Changes to the death certification process

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

    • From: Department of Health and Social Care
    • Updated:
  • Out-of-specification investigations

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: register to manufacture, import or distribute active substances

    Register as a manufacturer, importer or distributor of active substances.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: notes for applicants and holders of a wholesale dealer licence or broker registration

    Guidance to help applicants and licence holders get and maintain a wholesale dealer licence (WDA(H)) or broker registration – MHRA guidance note 6.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Adult safeguarding: statement of government policy

    Sets out government policy on safeguarding vulnerable adults, including a statement of principles for use by local authorities.

    • From: Department of Health and Social Care
    • Updated:
  • Culture change in the NHS

    Sets out the progress made in applying the lessons learned from the failings at Mid Staffordshire NHS Foundation Trust.

    • From: Department of Health and Social Care
    • Updated:
  • MHRA phase I accreditation scheme

    How to join the phase I accreditation scheme.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • FGM: mandatory reporting in healthcare

    Resources explaining healthcare professionals' duty to report cases of female genital mutilation (FGM) in girls under 18.

    • From: Department of Health and Social Care
    • Updated:
  • Custom-made medical devices in Great Britain

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Thirlwall Inquiry: terms of reference

    The Thirlwall Inquiry has been set up to examine events at the Countess of Chester Hospital and their implications following the trial, and subsequent convictions, of former neonatal nurse Lucy Letby of murder and attempted …

    • From: Department of Health and Social Care
    • Updated:
  • Blood: authorisations and safety reporting

    Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated: