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Data, Freedom of Information releases and corporate reports
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Patient factsheet providing information on influenza (flu) and flu vaccination.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
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 make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
This guidance summarises our approach to pharmacovigilance
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
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 on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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