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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 on the process for ending a clinical trial.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
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 makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to use the procedure for medicines licensing applications.
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 to help comply with ICH guidelines, if you are running clinical trials in the UK.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
You must get permission to export certain drugs and medicines.
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)’
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Clinical trial applications that need expert advice from a specialist group or committee.
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