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Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
Detailed guidance on advertising and promoting medicines.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
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.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
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.
Fees payable to the MHRA from 2025.
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