Regulatory Open Forum

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  • 1.  Fees for EMA Type 1A variation?

    Posted 10-Mar-2015 15:11
    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?

    Mary Todas RAC
    Regulatory Affairs Manager

    United States

  • 2.  RE: Fees for EMA Type 1A variation?

    Posted 11-Mar-2015 04:04
    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

    Hope this was relevant,

    Sven Hartmann
    Senior Manager Regulatory Affairs



  • 3.  RE: Fees for EMA Type 1A variation?

    Posted 12-Mar-2015 03:49
    It depends on via which procedure the product has received it MA; if it is a centralised procedure product then it is the EMA fee but if it is approved via nationalised procedure and/or MRP/DCP in diffrent countries in Europe then there are national fee legislations to consider.

    Hope this helps.

    Sanna Laine