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How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
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.
Information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
How to use the procedure for medicines licensing applications.
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…
Keep up to date with the latest information from the UK GLP monitoring authority.
Information on comparator products used in studies supporting abridged marketing authorisation application.
You must get permission to export certain drugs and medicines.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Guidance on clinical trials that are categorised as ‘notifiable’.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
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