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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How to get access to MHRA submissions portals, how to use them, where to go for help.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance on labelling for medicinal products used in clinical trials.
How the MHRA processes variations to marketing authorisations.
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 on the various types of modifications that can be made to a clinical trial approval.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
How to conform with the legal requirements for placing medical devices on the market.
How the MHRA makes decisions on what is a medicinal product (borderline products).
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Guidance on transitional arrangements for the Clinical Trials Regulations
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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