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A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
A letter providing guidance on the post-transition conversion process was sent by email on 23 October 2020 to the Community MA holders.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
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
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
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