Health Registration

Health Registration. Shall mean the technical, medical and scientific licenses, registrations, authorizations and/or approvals of a Product that are required by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local Governmental Authority or other governmental entity, for the manufacture, use or sale of the subject Product.

Health Registration. Means, with respect to a pharmaceutical product containing Product, all registrations with and approvals from the relevant Governmental Authority necessary to market and sell such pharmaceutical product in a given country or group of countries, including the technical, medical and scientific licenses, registrations, authorizations and/or approvals of such medicinal product (including any marketing authorizations, pricing approvals, reimbursement approvals, and labeling approvals, as... applicable). For the United States, the term Health Registration shall include a New Drug Application (NDA), for such pharmaceutical product and any amendments thereto.. For a Product in this Agreement, "Health Registration" shall also refer to the Health Registration for the Product's final finished form, as applicable. For clarity, Health Registrations shall exclude any permits specific to the Facility. View More