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Supplementary information for international regulators on packaging changes and the export of UK medicines.
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.
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
Industry must notify the MHRA if they will not be using these flexibilities
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
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 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).
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
How to use RamaXL, including system availability, running reports and how to subscribe.
MHRA scientific and regulatory advice for COVID-19 vaccine developers
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