Regulatory Approval

Regulatory Approval. Approval by the domiciliary insurance regulator of each insurance company under the management of GMACI under statutes and regulations which govern the management of insurers within a holding company system.

Regulatory Approval. Shall mean any registration submission or regulatory approval for a Product held by Siemens, its Affiliate or its Third Party designee

Regulatory Approval. All required regulatory approvals and consents by the GLC and any other governmental agency, quasi governmental agency, regulatory authority or legislative authority in the State of Georgia for the approval of the Georgia Project and grant of the VLT License to Owner.

Regulatory Approval. The national or multinational approval necessary to market, use, or sell a new medical device product to the public at large in a particular country or multi-national group of countries including without limitation throughout the European Union

Regulatory Approval. Means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations, clearances, or authorizations of any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are reasonably necessary for the manufacture, distribution, use or sale of a drug, biological, pharmaceutical, or medical device, as applicable, for human therapeutic or... prophylactic use in a particular jurisdiction. View More

Regulatory Approval. Means any technical, medical, scientific or other license, registration, authorization or approval of any Regulatory Authority regarding the research, development, clinical testing, commercial manufacture, distribution, marketing, pricing, reimbursement, Promotion, offer for sale, use, import, export or sale of any pharmaceutical product, proposed pharmaceutical product, medical device, proposed medical device, or any combination thereof.

Regulatory Approval. The authorization by an appropriate Regulatory Agency to market and sell a Licensed Product in a jurisdiction

Regulatory Approval. All approvals (including pricing and reimbursement approvals), and/or establishment licenses, registrations or authorizations of any regional, federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, storage, import, export, transport or sale of a Therapeutic Product or Diagnostic Product in a regulatory jurisdiction.

Regulatory Approval. Means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

Regulatory Approval. The permission or consent granted by the FDA for the Marketing of the Licensed Product in the Territory