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Medicines, medical devices

Guidance and regulation

337 results

337 results sorted by Most viewed
  • Contact MHRA

    How to contact MHRA for specific services or enquiries.

    • 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:
  • Valproate use by women and girls

    Information about the risks of taking valproate medicines during pregnancy.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Supply unlicensed medicinal products (specials)

    Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Ionising Radiation (Medical Exposure) Regulations 2017: guidance

    Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.

    • From: Department of Health and Social Care
    • Updated:
  • 150-day assessment for national applications for medicines

    Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medical devices: conformity assessment and the UKCA mark

    How to conform with the legal requirements for placing medical devices on the market.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Acting as a Responsible Person (import)

    A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Patient group directions (PGDs)

    Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Apply for a traditional herbal registration (THR)

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

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Innovative Licensing and Access Pathway

    A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Prescriptions issued in the EEA and Switzerland: guidance for pharmacists

    Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.

    • From: Department of Health and Social Care
    • Updated:
  • Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

    Pharmacovigilance system requirements

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

    The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Export drugs and medicines: special rules

    You must get permission to export certain drugs and medicines.

    • From: Home Office and 2 others
    • Updated:
  • Medical devices: software applications (apps)

    Information on when software applications are considered to be a medical device and how they are regulated.

    • 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:
  • Medical devices: UK approved bodies

    UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Apply for the early access to medicines scheme (EAMS)

    Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Variations to Marketing Authorisations (MAs)

    How the MHRA processes variations to Marketing Authorisations (MAs)

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