definiens: means ( a ) a New Drug Application, submitted to th e FDA pursuant to 21 CFR § 314.50 ( ) ; ( b ) a Biologics License Application submitted t o the FDA pursuant to Section 351(a ) of the Public Health Service Act and the regulations promulgated thereunder ( ) ; ( c ) an application for authorization to market and/ or sell a biological or pharmaceutical product submitted to a Regulatory Authority in any country or jurisdiction other than the U.S., includi ng, with respect to the European Union, a marketing authoriz ation application filed with the EMA pursuant to the Centralized Approval Procedure or with the appl icable Regulatory Authority of a country in the European Economic Area with respect to the decen tralized procedure, mutual recognition or any national approval procedure ( ) ; or ( d ) with respect to any biological or pharmaceutical pr oduct for which a NDA, BLA or MAA has been approved by th e applicable Regulatory Authority, an application to suppl ement or amend such NDA, BLA or MAA to expand the a pproved label for such biological product to include use of such biologica l product for an additional Indication