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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.
How the MHRA processes variations to marketing authorisations.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
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 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 the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Keep up to date with the latest information from the UK GLP monitoring authority.
Information about the MHRA graduate scheme which is currently closed for applications.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
You must get permission to export certain drugs and medicines.
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