Regulatory Authority

Regulatory Authority. With respect to any particular country, territory or union, the governmental authority, body, commission, agency or other instrumentality of such country, territory or union with the primary responsibility for the evaluation or approval of medical products before such medical product can be tested, marketed, promoted, distributed or sold in such country, territory or union including such governmental bodies that have jurisdiction over the pricing of such medical product. The term "Regulatory... Authority" includes, but is not limited to the FDA, the European Agency for the Evaluation of Medicinal Products (EMEA), European Member State Competent Authorities and the Ministry of Health, Labour and Welfare (MHLW) View More

Regulatory Authority. Means any and all bodies and organizations, including, without limitation, the FDA regulating the manufacture, importation, distribution, use and sale of the API and the Finished Products in the Territory.

Regulatory Authority. Any applicable supra-national, federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils, or other government entities, including without limitation the FDA, EMA and DCGI, regulating or otherwise exercising authority with respect to the Development, Manufacture or Commercialization of the Products in the Territory

Regulatory Authority. Means, with respect to any country or jurisdiction, any governmental authority involved in granting approval of the investigation, manufacture, distribution, marketing, sale, pricing or reimbursement of the Products in that country or jurisdiction, including the FDA in the United States.

Regulatory Authority. Means any Governmental Entity or authority responsible for granting Marketing Authorizations for Products and any successor entity thereto, and any corresponding national or regional regulatory authorities.

Regulatory Authority. The government of the United States or any foreign jurisdiction, any state, county, municipality or other governmental or quasi governmental unit or sub-unit, or any agency, board, bureau, instrumentality, department or commission (including any court or other tribunal) of any of the foregoing.

Regulatory Authority. The FDA or any other state or governing national or multinational regulatory authority or government agency that is equivalent to or has any similar regulatory functions and responsibilities as the FDA.

Regulatory Authority. The Food and Drug Administration of the United States (the FDA) or, any successor agency or, if applicable in the context, the government agency performing the same regulatory functions as the FDA in another country.

Regulatory Authority. Any federal, state or local governmental regulatory authority in the United States involved in regulating any aspect of the development, market approval, sale, distribution or use of the Product, the Packaging Materials or the Packaged Product. For purposes of this Agreement, the parties acknowledge and agree that notwithstanding anything to the contrary herein contained, Sharp shall only be subject to the authority of Regulatory Authorities of the United States and the Commonwealth of... Pennsylvania that have proper jurisdiction over the storage and packaging of the Product or Packaged Product and shall have no obligations with respect to any other Regulatory Authorities. View More

Regulatory Authority. Any U.S. regulatory or governmental authority, such as the U.S. Food and Drug Administration, and the European Agency for the Evaluation of Medicinal Products, or any successor agencies thereto.