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What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
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 the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
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.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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.
Industry must notify the MHRA if they will not be using these flexibilities
Information relating to the disapplication of falsified medicines under UK Law.
How to use RamaXL, including system availability, running reports and how to subscribe.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
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