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How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Information relating to good clinical practice (GCP) inspections.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance on transitional arrangements for the Clinical Trials Regulations.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Guidance on using non-investigational medicinal products in a clinical trial.
How to conform with the legal requirements for placing medical devices on the market.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
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'
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.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
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