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Information about how approved bodies help regulate medical devices and how to apply for approval.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
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.
Apply for and maintain registrations for the brokering of human medicines.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Information relating to the disapplication of falsified medicines under UK Law.
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 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.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Supplementary information for international regulators on packaging changes and the export of UK medicines.
summary
How the ‘Written Confirmation’ 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.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Guidance on moving medicines by air
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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