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Information relating to the disapplication of falsified medicines under UK Law.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
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.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
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.
The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
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.
MHRA scientific and regulatory advice for COVID-19 vaccine developers
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
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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