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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.
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.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
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
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
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.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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.
Information relating to the disapplication of falsified medicines under UK Law.
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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.
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.
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