Regulatory Authority

Regulatory Authority. Means the FDA, EMA and any other similar governmental authority, administrative agency or commission of any region, country, state, province or other political subdivision, any applicable government regulatory authority involved in regulating or granting approvals with respect to the manufacture, use, marketing or sale of pharmaceutical products.

Regulatory Authority. Means any domestic or foreign, federal, national, regional, state, county, city, municipal, local or other administrative, legislative regulatory or other governmental authority, agency, department, bureau, commission, or council involved in the granting of Regulatory Approval for the Product in the Territory.

Regulatory Authority. The United States Food and Drug Administration and any divisions thereof, any equivalent agency of any other country and any division thereof, and any other applicable regulatory body.

Regulatory Authority. Shall mean any and all bodies and organizations, including the FDA and DEA, regulating the manufacture, importation, distribution, use and sale of API and Commercial Product in the Territory.

Regulatory Authority. The FDA or any Foreign Regulatory

Regulatory Authority. Any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the research, development, manufacture, commercialization or other use (including the granting of Marketing Approvals) of the Product in any country in the Territory including, with respect to the U.S., the FDA, and with respect to the European Union (the E.U.), the EMEA.

Regulatory Authority. Any local, state, or federal regulatory authority having valid jurisdiction or exercising regulatory or similar oversight with respect to Lender, CSO, or Third Party Service Providers

Regulatory Authority. Means, with respect to a particular country or other regulatory jurisdiction, the regulatory agency, department, bureau or other governmental entity involved in regulating any aspect of the conduct, development, manufacture, market approval, sale, distribution, packaging or use of the Products.

Regulatory Authority. Any agency or authority responsible for regulation of Client Product in the United States or any foreign regulatory jurisdiction in which Client has marketing authorization for the Client Product, provided that Althea shall have no obligation to Produce Client Product in compliance with the requirements of any Regulatory Authority other than the US FDA and the EU EMA, except to the extent expressly specified in the Quality Agreement.

Regulatory Authority. Means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction