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Information on MHRA's enforcement duties and how to report a non-compliant medical device.
How to contact MHRA for specific services or enquiries.
Information on 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'
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.
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.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
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