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What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
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 on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information relating to the disapplication of falsified medicines under UK Law.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
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
Industry must notify the MHRA if they will not be using these flexibilities
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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.
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.
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
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