Hi Marc -- I think that is more of a theoretica
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Posted On: 09/15/2021 7:21:13 AM
Hi Marc --
I think that is more of a theoretical version of the process than the actual one. Here is a quote from the EMA (European Medicines Agency) bolding mine:
"The European system of approval of new medicines
comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on
different EU Member States working together and
recognising each other’s evaluations... Today, the purely national procedure
is rarely used by applicants and only when they seek
marketing authorisation in a single Member State."
So perhaps Portugal or Spain would be moved by the Brazil result. Better yet, the EMA would be. As I recall, CYDY has had discussions with the EMA, though I'm not sure if we have an application in -- an application requires a lot of paperwork, as it does for the FDA.
I think that is more of a theoretical version of the process than the actual one. Here is a quote from the EMA (European Medicines Agency) bolding mine:
"The European system of approval of new medicines
comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on
different EU Member States working together and
recognising each other’s evaluations... Today, the purely national procedure
is rarely used by applicants and only when they seek
marketing authorisation in a single Member State."
So perhaps Portugal or Spain would be moved by the Brazil result. Better yet, the EMA would be. As I recall, CYDY has had discussions with the EMA, though I'm not sure if we have an application in -- an application requires a lot of paperwork, as it does for the FDA.
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