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Patient safety

Guidance and regulation

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  • 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:
  • MHRA Portal: register to submit forms

    How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.

    • 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:
  • 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:
  • 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:
  • 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:
  • MHRA phase I accreditation scheme

    How to join the phase I accreditation scheme.

    • From: Medicines and Healthcare products Regulatory Agency
    • 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:
  • 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:
  • Duty of candour review: terms of reference

    The Department of Health and Social Care will lead a review into the duty of candour for health and social care providers in England.

    • From: Department of Health and Social Care
    • 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:
  • Managing medical devices

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

    • 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:
  • 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:
  • Legal requirements for children's medicines

    An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.

    • 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:
  • Cancel a medicine's marketing authorisation or other licence

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Magnetic resonance imaging equipment in clinical use: safety guidelines

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • A guide to defective medicinal products

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

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