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Medicines, medical devices

Guidance and regulation

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  • How to contact MHRA for specific services or enquiries.

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

  • Information about the risks of taking valproate medicines during pregnancy.

  • Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.

  • How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

  • 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'

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

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

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

  • You must get permission to export certain drugs and medicines.

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

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

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

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

  • This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.

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

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

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

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

  • A list of herbal ingredients which are banned or restricted for unlicensed medicines.