foreign regulatory authority definition

foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

foreign regulatory authority means any applicable regulatory agency, department, bureau or other governmental entity or authority of any country or regulatory jurisdiction in the Territory (other than the FDA in the United States), having responsibility in such country or regulatory jurisdiction for any Regulatory Approvals of any kind necessary for the development, pre-clinical and/or human clinical testing, manufacture, supply, marketing and/or sale of Licensed Products in such country or other regulatory jurisdiction.

foreign regulatory authority means any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory (other than the FDA in the United States), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

Examples of foreign regulatory authority in a sentence

• Notification to FDA (or such other Foreign Regulatory Authority or Government Authority) and conducting such Recall shall be the responsibility of Santarus.

• Further, Patheon shall fully and appropriately investigate and report to Santarus on all complaints and notices of quality issues concerning the Finished Products from the FDA, any Foreign Regulatory Authority or Government Authority of which Santarus shall have given Patheon notice.

• If an amendment to the Specifications requires FDA approval and/or the approval of a Foreign Regulatory Authority, Patheon shall not implement such change unless and until the necessary approval has been obtained by Santarus in writing.

• Notifications of Serious Adverse Events and Unexpected Adverse Events shall be given contemporaneously with notifications of such Serious Adverse Events or Unexpected Adverse Events to any regulatory authority, including the FDA or any Foreign Regulatory Authority.

• Except with regard to clinical trials conducted by SG on SGN 11&12, all data produced as a result of clinical trials conducted under this Agreement shall be owned by GNE, except to the extent in conflict with the requirements of the FDA or any Foreign Regulatory Authority, and all such data shall be considered Confidential Information of GNE.

More Definitions of foreign regulatory authority

foreign regulatory authority means an authority which, in a foreign country, exercises any function corresponding to any regulatory or supervisory function of the Bank in terms of this Act;

foreign regulatory authority means an authority in a foreign jurisdiction that exercises regulatory or supervisory functions over entities carrying on banking, insurance, securities or other financial services

foreign regulatory authority means an authority in a jurisdiction outside Montserrat which exercises a regulatory function;

foreign regulatory authority means, for each country other than the United States of America, the authority or authorities having jurisdiction over the Finished Product that correspond to the FDA.

foreign regulatory authority means an authority in a foreign jurisdiction that exercises regulatory, supervisory, enforcement or similar functions and includes-

foreign regulatory authority means a regulatory authority outside Namibia, which performs the same or substantially the same functions as the Authority and whose standards are acceptable to the Authority;

foreign regulatory authority means an authority in a jurisdiction outside Belize which exercises a regulatory function similar to that of the Registrar;