definiens: means, with respect to a Drug Approval Application filed for a Licensed Product, ( a ) in the UnitedStates, the receipt of written notice from the FDA in accordance with 21 CFR 314.101(a)(2 ) that such D rug ApprovalApplication is officially ; ( b ) in the Europ ean Union, receipt of written notice of acceptance by the EMEA of such DrugApproval Application for filing under the centraliz ed European procedure in accordance with any feedba ck received fromEuropean Regulatory Authorities ; provided, that, if the centralized filing procedure is not used, then Acceptance shall bedetermined upon the acceptance of such Drug Approva l Application by the applicable Regulatory Authorit y in any Europeancountry ; and ( c ) in Japan, receipt by KHK of writte n notice of acceptance of filing of such Drug Appro val Application fromthe Japanese Ministry of Health, Labor and Welfare ( )