UK BREXIT – eCTD BASELINE for Converting CAPs into UK MAs
9 October 2020
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s stand-alone medicines and medical devices regulator.
In this context MHRA has released the following guidance – “Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes” focused on:
In this context, BlueReg has already worked on the guidance and set up the support and solutions so that its clients can convert their procedures from centralized procedures to National MAs while limiting the impact on their business as much as possible.
Thus, BlueReg can help you on:
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