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What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Information relating to parallel imports and the implementation of the Windsor Framework.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
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.
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 regulations.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
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 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.
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
How to move medicines safely by air, following good distribution practice (GDP).
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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Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
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