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Dear Forum,
Regarding the Centralised Procedure in EMA, I can easily see the advantages (1 EU assessment, 1 approval in all EU, safety for all EU, availability of the drug for all EU citizens, less work for regulators...).
But, in case our product is NOT mandatory for CP but is eligible for CP under the optional CP pathway and considering the case that we intend to launch the product in more than 1 EU country, what will be the parameters to choose between the CP and the MRP/DCP?
What are the pros (and cons) of the MRP/DCP over the CP?
Regarding DCP: my understanding is that we submit simultaneously a new application in a few countries and we chose an RMS.
Regarding the MRP: we can use this pathway once the application is already approved in one country. But, under which procedure the product is already approved? Are we doing a national procedure prior to the MRP? Or, are we doing an MRP in 2 stages: the first one to the RMS and then afterwards the second stage to all other countries?
What are the pros and cons of MRP vs DCP?
Thank you in advance for your assistance.