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Medicines, medical devices

Guidance and regulation

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327 results sorted by Most viewed
  • Regulating medical devices in the UK

    What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Find product information about medicines

    Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Register medical devices to place on the market

    How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines that you cannot export from the UK or hoard

    Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.

    • From: Department of Health and Social Care and 1 others
    • Updated:
  • Drug Safety Update: monthly PDF newsletter

    Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Clinical trials for medicines: apply for authorisation in the UK

    How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Apply for a licence to market a medicine in the UK

    An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Valproate use by women and girls

    Information about the risks of taking valproate medicines during pregnancy.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Good manufacturing practice and good distribution practice

    Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.

    • From: Department of Health and Social Care and 1 others
    • Updated:
  • The Yellow Card scheme: guidance for healthcare professionals, patients and the public

    Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • E-cigarettes: regulations for consumer products

    Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • The Innovative Devices Access Pathway (IDAP)

    The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Clinical trials for medicines: manage your authorisation, report safety issues

    Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: packaging, labelling and patient information leaflets

    How to package medicines for sale and what information you must provide to consumers and healthcare professionals.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Notify the MHRA about a clinical investigation for a medical device

    How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: reclassify your product

    Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Good clinical practice for clinical trials

    How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: apply for a variation to your marketing authorisation

    Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medical devices regulations: compliance and enforcement

    Information on MHRA's enforcement duties and how to report a non-compliant medical device.

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

    How to contact MHRA for specific services or enquiries.

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