Marketing Authorization definition

Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed 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

• Marketing Authorization Holder: The company or legal entity in whose name the marketing authorization for a product has been granted and is responsible for all aspects of the product and compliance with the conditions of marketing authorization.

• This is due to the occurrence of very deep groundwater volumes, whereas the groundwater volume in the upper 100 m is more limited.

• BI shall be solely responsible for, and shall use Diligent Efforts in the Major Markets in connection with, the submission of information, communicating with, and seeking Marketing Authorization Approvals from, Governmental Authorities in respect of Products and will keep Vitae informed, through the Joint Steering Committee or applicable subcommittee, of all significant issues arising therefrom.

• An MA is thus granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorization) Regulations, under the Medicines Act, 2003, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004].

• For drugs, the Local Representative or the Marketing Authorization Holder shall permanently and continuously have at his disposal an appropriately Qualified Person Responsible for Pharmacovigilance resident in Ghana.

More Definitions of Marketing Authorization

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.

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 any approvals, authorizations, licenses or registrations from a relevant health authority for the distribution, promotion, marketing and sale of a drug product.

Marketing Authorization means an approved New Drug Application as defined in the FDA Act and the regulations promulgated thereunder, or any corresponding foreign application, registration, or certification, necessary or reasonably useful to market any Product in a country or regulatory jurisdiction other than the United States, including applicable pricing and reimbursement approvals, and all supplements and amendments thereto.

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 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 a particular jurisdiction in the Territory, any authorization which is legally required under applicable laws, regulations, administrative decisions, or otherwise to put a pharmaceutical product on the market or for commercial sale in the jurisdiction for use in treatment of any indication. It is understood that, as used herein, Marketing Authorization does not include pricing or reimbursement approval.