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This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
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.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information relating to parallel imports and the implementation of the Windsor Framework.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
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
Supplementary information for international regulators on packaging changes and the export of UK medicines.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
summary
Information relating to the disapplication of falsified medicines under UK Law.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Guidance on moving medicines by air
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