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Apply for and maintain registrations for the brokering of human medicines.
Information about how approved bodies help regulate medical devices and how to apply for approval.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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.
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.
How the 鈥榃ritten Confirmation鈥� process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
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.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
summary
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance on moving medicines by air
UK businesses can apply for a share of up to 拢8 million from the Industrial Strategy Challenge Fund for capital projects to improve medicines manufacturing.
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