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Medicines, medical devices

Guidance and regulation

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  • Medical devices: how to comply with the legal requirements in Great Britain

    What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Import a human medicine

    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.

    • From: Department of Health and Social Care and 1 others
    • Updated:
  • Variations to Marketing Authorisations (MAs)

    How the MHRA processes variations to Marketing Authorisations (MAs)

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Implementation of medical devices future regime

    The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

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

    The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.

    • 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:
  • Pregabalin and risks in pregnancy

    Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Procedures for UK Paediatric Investigation Plan (PIPs)

    The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Drugs and pharmaceutical electronic market information tool (eMIT)

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

    • From: Department of Health and Social Care
    • Updated:
  • Medicines: get scientific advice from MHRA

    How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.

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

    Fees payable to the MHRA for 2023 to 2024

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Guidance on substantial amendments to a clinical trial

    Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines

    Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Safety Public Assessment Reports

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Make a payment to MHRA

    How to make a payment to MHRA by credit or debit card or a bank transfer.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Borderlines with medical devices and other products in Great Britain

    Guidance on whether or not your product is a medical device.

    • From: Medicines and Healthcare products Regulatory Agency
    • 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:
  • Borderline products: how to tell if your product is a medical device and which risk class applies

    How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Parental Leave policy and procedures

    Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Blue Guide: advertising and promoting medicines

    Detailed guidance on advertising and promoting medicines.

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