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You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Information on comparator products used in studies supporting abridged marketing authorisation application.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
How to use the procedure for medicines licensing applications.
How to conform with the legal requirements for placing medical devices on the market.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
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.
Guidance on transitional arrangements for the Clinical Trials Regulations.
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Detailed guidance on advertising and promoting medicines.
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
How the MHRA makes decisions on what is a medicinal product (borderline products).
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Do not include personal or financial information like your National Insurance number or credit card details.
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