definiens: shall mean a New Animal Drug Application and any related supplemental applications and an Abbreviated New AnimalDrug Application submitted to the FDA pursuant to 21 U.S.C. 360b ( or its successor statutory provision ), a Conditional New Animal Drug Applicationsubmitted to the FDA pursuant to 21 U.S.C. 360ccc ( or its successor statutory provision ), a request for an index listing submitted to the FDA pursuant to21 U.S.C. 360ccc-1 ( or its successor statutory provision ), a request for authorization for veterinary medical products for use in emergencies submitted tothe FDA pursuant to 21 U.S.C. 360bbb-3 ( or its successor statutory provision ), and a Veterinary Master File, or the equivalent application or filing filedwith any equivalent regulatory agency or governmental authority outside the U.S. necessary to sell a Regulated Product in such jurisdiction ( including amarketing authorization application or dossier filed with the applicable regulatory agency of a European Union member state or with the EuropeanMedicines Agency for a veterinary medicinal product )