Drug Approval Application

Drug Approval Application. Shall mean an application for Regulatory Approval required before commercial sale or use of Product as a drug in a regulatory jurisdiction.

Drug Approval Application. Means (i) a Biologics License Application or a New Drug Application, as defined in the Act, and the regulations promulgated thereunder, or (ii) any corresponding foreign application in or with respect to the European Union, including a Marketing Authorization Application filed with the EMEA pursuant to the centralized approval procedure or with the applicable regulatory authority of a country in the European Union with respect to the mutual recognition or any other national approval procedure,... or (iii) any corresponding foreign application in or with respect to Japan, including a Japanese New Drug Application filed with the Japan Ministry of Health, or (iv) any corresponding application in or with respect to any other country that is required by the country's Regulatory Authority or other applicable health authority to obtain marketing approval for a pharmaceutical product. View More

Drug Approval Application. Means an application for Regulatory Approval required before commercial sale or use of a product as a drug in the Territory.

Drug Approval Application. An application for product license approvals, health registrations, marketing authorizations, regulatory submissions, notices of compliance and other licenses and permits (NDA and the like) required to be approved before commercial sale or use of a PRODUCT as a drug in a regulatory jurisdiction.

Drug Approval Application. Any application for Regulatory Approval, including, without limitation, (a) any application filed with the FDA and (b) any equivalent application filed with any Foreign Regulatory Authority for Regulatory Approval required prior to any sale or use or any Commercialization of a Licensed Product in any country or jurisdiction in the Territory

Drug Approval Application. An application to a Regulatory Authority for Regulatory Approval of the Covered Product in the Territory.