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How to write clear and effective field safety notices (FSNs) for medical devices.
Keep up to date with the latest information from the UK GLP monitoring authority.
How to change the ownership from one marketing authorisation (MA) holder to another.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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.
How to use the procedure for medicines licensing applications.
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.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
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.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Clinical trial applications that need expert advice from a specialist group or committee.
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 we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
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