definiens: shall mean : ( a ) a Biologics License Application submitted to the FDApursuant to Section 351(a ) of the Public Health Service Act ( ) or a New Drug Application ( as more fully deﬁned in21 CFR 314.5, et seq . ) ﬁled with the FDA, or any successor a pplication thereto in the U.S. ( ) ; ( b ) an application forauthorization to market or sell a pharmaceutical or biol ogical product submitted to a Regulatory Authority in any country orjurisdiction other than the U.S., including, with respect to the EU, a marketing authorization application ﬁled w ith the EMApursuant to the Centralized Approval Procedure or with th e applicable Regulatory Authority of a country in the Euro peanEconomic Area with respect to the decentralized procedure, m utual recognition or any national approval procedure ( ) ; or ( c ) with respect to any product for which a BLA, NDA or M AA has been approved by the applicable Regulatory Authority, an application to supplement or amend such BLA, NDA or MAA t o expand the approved label for such pharmaceutical orbiological product to include use of such pharmaceutical or biological product for an additional indication