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Data, Freedom of Information releases and corporate reports
How to use the procedure for medicines licensing applications.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
You must get permission to export certain drugs and medicines.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
Guidance on clinical trials that are categorised as ‘notifiable’.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Keep up to date with the latest information from the UK GLP monitoring authority.
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
Information on comparator products used in studies supporting abridged marketing authorisation application.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Fees payable to the MHRA from 2025.
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.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Detailed guidance on advertising and promoting medicines.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
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