Posted Thu, 25 Mar 2021 12:34:29 GMT by Bénédicte Perret
Dears,
I would like some clarification regarding the process for requesting a RPI for a product in development including several substances already available in SMS.
Could you please confirm that the Company is allowed to select multiple substances available from SMS to relate to one RPI identifying the product in development for which the Company wish to submit a scientific advice application in the future?
It seems that the Company need to provide a product name to relate to the requested RPI. Would you please clarify the process on where or how to provide such name? Would you please clarify whether this name will become public at some point?
Thanks in advance for the clarifications
Posted Thu, 25 Mar 2021 21:46:12 GMT by Paolo Tomasi EMA
Your understanding is correct: an RPI is intended for a single medicinal product/development, including fixed-dose combination products (FDCs). It is thus possible in IRIS to select more than one SMS substance when requesting a new RPI.
However, for separate products to be co-administered, or for so-called combination packs, separate RPIs should be requested.
There is no need for the requester to provide a "product name" to relate to the requested RPI: the name of the RPI is simply the name of the active substance, or the concatenation of the active substances in alphabetical order (if more than one). 
Finally, there are currently no plans to make the list of EMA RPIs public.  

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