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How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to conform with the legal requirements for placing medical devices on the market.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Provides a standard framework for NHS procurement professionals to assess non-financial value when buying medical technology.
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.
Fees payable to the MHRA from 2025.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
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.
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 the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Detailed guidance on advertising and promoting medicines.
Do not include personal or financial information like your National Insurance number or credit card details.
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