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Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
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 process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
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
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.
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