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Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients.
This report examines the UK鈥檚 current capabilities and identifies where they would need to be strengthened to better enable the UK to develop AMRs.
How to apply for alternative dispute resolution and when you can use it to resolve a tax disagreement with HMRC.
Reviews the available data on concentrations at which selection for antimicrobial resistance has been reported for different antimicrobials and the approaches used to determine these concentrations.
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