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Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
Apply for and maintain registrations for the brokering of human medicines.
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How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Information relating to the disapplication of falsified medicines under UK Law.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Guidance on moving medicines by air
UK businesses can apply for a share of up to £8 million from the Industrial Strategy Challenge Fund for capital projects to improve medicines manufacturing.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Don’t include personal or financial information like your National Insurance number or credit card details.
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