Posted Fri, 08 Nov 2024 08:58:11 GMT by Federica Mori Senior Global Program Regulatory Manager
Does the field "foreseen date of the next Marketing Authorisation application submission for this RPI" also cover any potential future submission for new indication ?
I am asking as if a product is approved and no additional MAA planned, the most intuitive action would be to consider this field as N/A and insert the date 21/12/2099 as suggested by the system. However the system is then still requiring the compilation of the other two following fields "foreseen legal basis of next MAA" and "foreseen eligibility basis of next MAA" and there is no option to select them as N/A. 
 
Posted Mon, 11 Nov 2024 11:35:36 GMT by Paolo Tomasi EMA
The field "foreseen date of the next Marketing Authorisation application submission for this RPI" does NOT cover variations for an existing Marketing authorisation, but only new MAAs, for example a new MAA for an orphan condition when the same RPI already is linked to a "standard" (non-orphan) authorisation product, or when a generic version is developed for an existing "standard" authorisation product. If no new MAA are foreseen for the RPI in the future, then 31/12/2099 should be specified (not 21/12/2099). 
The fields "foreseen legal basis of next MAA" and "foreseen eligibility basis of next MAA" should include the option to select "N/A" for these situations, this is a known bug and it is scheduled to be fixed soon; until then, please select the existing legal basis and eligibility basis. 

You must be signed in to post in this forum.