Regulatory Approval

Regulatory Approval. Means all authorizations by the competent Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of a Product in a given country or regulatory jurisdiction in the Territory.

Regulatory Approval. Means, with respect to a Product, all approvals, licenses, registrations or authorizations necessary for the commercialization of such Product in a particular jurisdiction.

Regulatory Approval. The approval, registration, license or authorization of a Governmental Authority necessary for the manufacturing, distribution, use, promotion or sale of a Product for one or more indications in a country or other regulatory jurisdiction, including approval of Biologics License Applications (as defined by applicable Law) in the United States and Marketing Authorizations in the European Union or other European countries.

Regulatory Approval. With respect to any jurisdiction, those approvals or authorizations of a regulatory authority that are necessary for the commercial marketing and sale of a pharmaceutical product in such jurisdiction.

Regulatory Approval. All approvals, licenses, registrations, and authorizations of any federal, national, multinational, state, provincial, or local Regulatory Authority, department, bureau, and other governmental entity that are necessary and sufficient for the marketing and sale of a product in a country or group of countries

Regulatory Approval. The approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations or authorizations of Regulatory Authorities necessary for the development, manufacture, use, offer for sale, sale or importation of a product in a country or territory

Regulatory Approval. All authorizations by the appropriate Regulatory Authority necessary for commercial sale of Finished Product in a jurisdiction

Regulatory Approval. Shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals of any national (e.g., the FDA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the Research, Development, Manufacture and Commercialization of Licensed Product(s) in the Territory, including, without limitation, INDs and other submissions and approvals necessary to conduct clinical studies, approvals of ND As, •... supplements and amendments, pre- and post- approvals, and labeling approvals. View More

Regulatory Approval. Means receipt of all approvals, licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, ministry, department, bureau or other government entity that are necessary for the use or sale of a particular Product in the jurisdiction for a particular indication, including any approvals for importation, manufacture, pricing, and/or reimbursement where necessary for effective market entry.

Regulatory Approval. Means, for a particular country, approval by the applicable Regulatory Authority of any and all filings required for the commercial marketing or sales of any product (or component thereof) in such country, along with satisfaction of any related applicable regulatory requirements.