Initial Regulatory Authorization definition

Initial Regulatory Authorization of a Licensed Product for an indication means (a) with respect to the United States, the approval by the FDA and, (b) with respect to a country or jurisdiction other than the United States, the approval by the applicable Regulatory Authorities of the NDA with respect to such Licensed Product for such indication in the applicable regulatory jurisdiction.
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Initial Regulatory Authorization of the Licensed Product for an indication means the approval by the FDA.
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Related to Initial Regulatory Authorization

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • national regulatory authority means a national regulatory authority designated in accordance with Article 39(1) of Directive 2009/73/EC;

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the ▇▇▇▇ ▇▇▇.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Regulatory Authorities means the Commissions and the Exchange;