definiens: means, with respect to an NDA, MAA, or JNDA filed for a Product, ( a ) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. § 314.101(a)(2 ) that su ch NDA is officially, ( b ) in the European Union, receipt of written no tice of validation by the EMA of such MAA under the centralized European procedure in accorda nce with any feedback received from European Regula tory Authorities ; provided that if the centralized filing procedure is not used, t hen Acceptance of Filing will be determined upon the validation of such MAA by the a pplicable Regulatory Authority in a Major Market in Europe, and ( c ) in Japan, receipt of written notice of acce ptance of filing of such JNDA from the Koseisho ( i. e., the Japanese Ministry of Health and Welfare, or any successor ag ency thereto )