Dear Mary,
My understanding is that in case of a
Central Procedure, fees would only have to be paid to EMA.
In case your customer has the product registered via any of the other routes (
MRP, DCP, purely national), the fees would not go to EMA but to the individual country authorities. These fees would vary widely for type IA submissions (ranging from no fees at all, e.g. UK to some hundred EUR, e.g. Italy 660 EUR). In case of an MRP, the overall sum may be much higher than the 3000 EUR for a type IA(IN) in a CP. There is a nice fee calculator available at
http://regulatory-fees.eu/calculator/. Hope this was relevant,
Sven
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Sven Hartmann
Senior Manager Regulatory Affairs
Germany
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Original Message:
Sent: 03-10-2015 15:11
From: Mary Todas
Subject: Fees for EMA Type 1A variation?
I'm trying to estimate the fees a customer of mine will incur if we ask them to update their European market authorizations with a Type 1A (IN) change. I see the 3000 Euro fee to EMA, but will they have to pay additional fees to the individual market authorization countries?
thanks!
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Mary Todas RAC
Regulatory Affairs Manager
United States
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