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How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Information about the MHRA graduate scheme which is currently closed for applications.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
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)’
Clinical trial applications that need expert advice from a specialist group or committee.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Keep up to date with the latest information from the UK GLP monitoring authority.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
You must get permission to export certain drugs and medicines.
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.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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