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Guidance on what approved bodies are, what they do and how you can become one.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Approved countries for batch testing and importation of medicines
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
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 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 for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Information relating to the disapplication of falsified medicines under UK Law.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
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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.
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