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).
Marketing Authorization means the permit, authorization and/or license for the Products issued by the relevant health authorities in the Territory, the underlying applications thereto, and any supplements and amendments to such Government Authorizations that authorize the holder of such license to market and sell the Products in the Territory.
Marketing Authorization means the grant of all necessary final or conditional permits, registrations, authorizations, licenses, and approvals (or waivers) required for the Commercialization of the Licensed Product for use in the Field and in the Territory, including any Regulatory Approval for sale or marketing, and, where applicable, Pricing and Reimbursement Approvals.
Examples of Marketing Authorization in a sentence
Effective as of the Effective Date and during the term, HARROW shall use Commercially Reasonable Efforts to Commercialize the Licensed Product in the Field in the Territory for which the Marketing Authorization has been obtained.
More Definitions of Marketing Authorization
Marketing Authorization means any approvals, authorizations, licenses or registrations from a relevant health authority for the distribution, promotion, marketing and sale of a drug product.
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 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 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 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, with respect to any Product, an applicable Regulatory Authorization to market and sell the Product in an applicable market, including all post-approval commitments, supplements and amendments to such an application, but excluding any pricing and reimbursement approvals.
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.