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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.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
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.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Information relating to the disapplication of falsified medicines under UK Law.
How to use RamaXL, including system availability, running reports and how to subscribe.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
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