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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.
Fees payable to the MHRA from 2025.
Guidance on the process for ending a clinical trial.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
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.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Keep up to date with the latest information from the UK GLP monitoring authority.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.
How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Clinical trial applications that need expert advice from a specialist group or committee.
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