MHRA updates CAP conversion guidance

by | Dec 1, 2020 | News Items

The Medicines and Healthcare products Regulatory Agency has updated its post-Brexit transition guidance regarding the conversion of Centrally Authorised Products to UK Marketing Authorisations. 

The MHRA has updated sections 6–8 and the associated Annex table to include additional potential scenarios and clarified various options available to applicants regarding the MHRA’s processing and determination of pending Type IB and II variations at the time of the baseline submission, and any subsequently submitted.  

 

The updated guidance is available here

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