Marketing Authorization definition

Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).

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Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

Marketing Authorization means approval from the relevant Governmental Authority necessary to market and sell Product in the Territory as a pharmaceutical or commercial product in any formulation or dosage form, together with ah subsequent submissions, supplements and amendments thereto.

Examples of Marketing Authorization in a sentence

• Unless otherwise set out in the Quality Agreement, Purchaser shall have the right to audit, on at least [***] prior written notice, (a) the sites of registered starting materials manufacturers, API manufacturers, CDMOs and Supplier, (b) warehouses where the Product may be stored, and (c) all Facilities listed in the Marketing Authorization or involved in the Product Manufacture and supply, [***].

• Within [***] Business Days of Supplier’s receipt of Purchaser’s request to meet, or such shorter time period as may be required by such Regulatory Authority, the Parties shall meet and determine if such Manufacturing Change would (i) impact Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (ii) require notice to or approval of a Regulatory Authority in the Territory or (iii) require approval of Purchaser under the terms of the Quality Agreement.

• If Purchaser believes such proposed Manufacturing Change (x) impacts Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (y) requires notice to or approval of a Regulatory Authority in the Territory or (z) requires approval of Purchaser under the terms of the Quality Agreement, then Purchaser shall include in the Change Response a request to meet with Supplier to determine if such proposed Manufacturing Change meets subclauses (x) through (z) above.

• Any Major Manufacturing Change that impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization or requires the approval of a Regulatory Authority in the Territory or approval of Purchaser under the terms of the Quality Agreement shall require the mutual agreement of the Parties and the approval of the Regulatory Authority (as applicable) prior to implementation.

More Definitions of Marketing Authorization

Marketing Authorization or "MA" means the authorization granted by the relevant Governmental Authority for the marketing, sale and/or distribution of the Product.

Marketing Authorization means the procurement of registrations and permits required by applicable government authorities in a country in the Territory for the marketing, sale, and distribution of a Product in such country;

Marketing Authorization means an approved New Drug Application as defined in the FFDCA and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification, necessary or reasonably useful to market the Product in countries or regulatory jurisdictions in the Territory other than the United States, including applicable pricing and reimbursement approvals.

Marketing Authorization means such governmental approval (including pricing approval, where required) for the marketing of a Product in a country of the Territory as is necessary to enable sale and distribution of the Product in such country, which approval results from an NDA Filing or an equivalent filing.

Marketing Authorization means the granting or authorization, by an appropriate governmental agency, to commercialize a pharmaceutical product; by way of example, the FDA is an appropriate governmental agency.

Marketing Authorization means the certificate of registration issued by the competent health product regulatory authority in the country of origin for the purpose of marketing or free distribution of a health product after evaluation for safety, efficacy and quality;

Marketing Authorization means all allowances and approvals (including pricing and reimbursement approvals) granted by the appropriate federal, state and local regulatory agencies, departments, bureaus or other governmental entities within a country necessary to market and SELL PRODUCT.