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Information about how approved bodies help regulate medical devices and how to apply for approval.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information relating to the disapplication of falsified medicines under UK Law.
How to use RamaXL, including system availability, running reports and how to subscribe.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Industry must notify the MHRA if they will not be using these flexibilities
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