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Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
Industry must notify the MHRA if they will not be using these flexibilities
How to use RamaXL, including system availability, running reports and how to subscribe.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
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