Regulatory Authority definition

Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

Regulatory Authority means any applicable Government Authority responsible for granting Regulatory Approvals for Products, including the FDA, the EMA and any corresponding national or regional regulatory authorities.

Examples of Regulatory Authority in a sentence

• Any additional Data or report requested by Viking beyond the scope of GMP and customary FDA, EMEA or other Regulatory Authority requirements will be subject to an additional reasonable fee to be agreed upon between Corden and Viking.

• Dealer represents that it is a broker-dealer properly registered and qualified under all applicable federal, state and local laws to engage in the business and transactions described in this agreement and is a member in good standing of the Financial Industry Regulatory Authority (“FINRA”) and the Securities Investor Protection Corporation (“SIPC”).

• Notwithstanding the foregoing, (i) any preparatory audits conducted in preparation for an approval inspection by a Regulatory Authority may be conducted in addition to the foregoing audit and (ii) Viking may conduct additional audits more frequently than [...***...] in the event any audit conducted by Viking (and with respect to which Viking has provided a copy of the audit findings to Corden) or an audit by a Regulatory Authority reveals a material compliance deficiency.

• Viking may review Xxxxxx’s responses to any such reports and communications, and, if practicable, and, insofar as timely received, Viking’s comments, views and requests shall be taken into account prior to submission of such reports and communications to the relevant Regulatory Authority.

• Notification to the applicable Regulatory Authority, such as the FDA or EMEA, and compliance with Applicable Laws in conducting such Recall, shall be the responsibility of [...***...].

More Definitions of Regulatory Authority

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

Regulatory Authority means any federal or state banking, other regulatory, self-regulatory or enforcement authority or any court, administrative agency or commission or other governmental authority or instrumentality.

Regulatory Authority means (a) the FDA, (b) the EMA or the European Commission, or (c) any regulatory body with similar regulatory authority over pharmaceutical or biotechnology products in any other jurisdiction anywhere in the world.

Regulatory Authority means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

Regulatory Authority means, with respect to a country in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of Regulatory Approvals or Price Approvals for pharmaceutical products in such country or countries.

Regulatory Authority means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or regulatory jurisdiction, including (i) in the U.S., the FDA, and (ii) in the EU, the EMA, the European Commission and relevant national medicines regulatory authorities.

Regulatory Authority means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other Governmental Authority with authority over the Development, Manufacture, or Commercialization of the Licensed Product in a country.