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Departments, agencies and public bodies
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Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Information about how approved bodies help regulate medical devices and how to apply for approval.
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.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
summary
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
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.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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