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Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
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.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
A letter providing guidance on the post-transition conversion process was sent by email on 23 October 2020 to the Community MA holders.
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
MHRA scientific and regulatory advice for COVID-19 vaccine developers
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