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A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
A letter providing guidance on the post-transition conversion process was sent by email on 23 October 2020 to the Community MA holders.
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
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.
MHRA scientific and regulatory advice for COVID-19 vaccine developers
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
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