Regulatory Authority

Regulatory Authority. Means any national, state, provincial, or local or any foreign or supranational government, governmental, regulatory or administrative authority, agency or commission of any court, tribunal or judicial or arbitral body.

Regulatory Authority. Any governmental authority with jurisdiction over the manufacture, distribution, use, and marketing of in vitro diagnostics and/or new drug products intended for human use, including the FDA.

Regulatory Authority. Any governmental agency or authority responsible for regulation of Client Product in the Territory that have jurisdiction over the Client Product, whether relating to the development, manufacture, handling, storage transportation, destruction or otherwise. Althea shall have no obligation to Produce Client Product in compliance with the requirements of any non-U.S. Regulatory Authority, except as expressly specified in a Project Scope.

Regulatory Authority. Any applicable federal, state, local, or foreign regulatory agency, department, bureau, or other governmental agency (including a court of competent jurisdiction) and includes for the purposes of this Agreement an ISO Certified Body.

Regulatory Authority. The United States Food and Drug Administration or any successor entity and its equivalent in other countries of the Territory, including, but not limited to, EMEA

Regulatory Authority. The applicable government regulatory authority in any country in the Territory involved in granting the Health Registrations for Drug Product or otherwise having authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of Drug Product. Such term includes, without limitation, the FDA, the Committee for Medicinal Products for Human Use (CHMP) within the European Union and the national medicines agencies of countries... within the European Union, and any successors thereto. View More

Regulatory Authority. The FDA or EMA, or a regulatory authority in other jurisdictions with equivalent authority

Regulatory Authority. As applicable, the FDA, the European Medicines Agency, and/or any other analogous regulatory authority or agency in a country or region in the Markets.

Regulatory Authority. Any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, manufacture, use, storage, import, promotion, marketing and sale of a pharmaceutical product in a country, including but not limited to the FDA and EMEA

Regulatory Authority. Means the FDA or other governmental entity in the Territory responsible for Regulatory Approval.