Bioequivalence and Bioavailability Forum

Dear Sir,
This is wrt synapse CRO issue Article 31 is triggered by AEMPS, procedure being already started, impacting authorised MAA and ongoing procedures using Synapse BE study. We would like to know ur expert opinion on the MHRA authorisations in case of the negative outcome of this procedure (revocations/ suspensions of MAA), or how it was handled by MHRA in similar case of Synchron BE studies and EU suspended all the related product! May I request your kind advice wrt impact on UK licenses in this scenario ! Thank you!

Regards,
Ajay Gupta

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]