Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).
Marketing Authorization means the grant of any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use and sale of a Product in a regulatory jurisdiction, including where required, pricing and reimbursement approvals.
Marketing Authorization or "MA" means the authorization granted by the relevant Governmental Authority for the marketing, sale and/or distribution of the Product.
Examples of Marketing Authorization in a sentence
In October, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.
More Definitions of Marketing Authorization
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 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 a necessary approval from the FDA or other Regulatory Authority to market and sell a biologics or pharmaceutical product in any country or region, as applicable.
Marketing Authorization means all approvals (including labeling, price and reimbursement approvals, if applicable), licenses, registrations or authorizations of any Regulatory Authority necessary for the commercial marketing, sale and use of the Product inside or outside of the Territory, as the case may be.
Marketing Authorization means all approvals (including pricing and reimbursement approvals) and licenses, registrations or authorizations of a Regulatory Authority, necessary for the use, import, storage, export, transport, filling, labeling, packaging, manufacture or sale of a Product in a regulatory jurisdiction in the Territory.
Marketing Authorization means the marketing authorization, or such other permission having similar effect, in respect of the Product granted by both (a) (i) the FDA, or (ii) European Commission, and (b) (i) NAM or (ii) the Minister of Health and Social Protection from time to time, that allows the Product to be placed on the market in such country or territory according to Law.