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Data, Freedom of Information releases and corporate reports
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Information relating to parallel imports and the implementation of the Windsor Framework.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
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Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Information relating to the disapplication of falsified medicines under UK Law.
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.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
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