Marketing Authorization definition

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 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, with respect to a Country, the ----------------------- regulatory authorization required to market and sell a Collaboration Product in such Country as granted by the relevant Governmental Authority.

Examples of Marketing Authorization in a sentence

  • Time to Entry for New Cancer Medicines: From European Union–Wide Marketing Authorization to Patient Access in Belgium, Estonia, Scotland, and Sweden.

  • In pursuance to Public Health Act 2012, Act 851, Part 7, Section 125, subsection, these guidelines are hereby promulgated for information, guidance and strict compliance by Healthcare Professionals, Local Representatives appointed by Marketing Authorization Holders and Manufacturers and the Food and Drugs Authority to help in the continuous safety monitoring of products granted marketing authorization in Ghana.

  • 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.

  • In such a situation, the Local Representative or Marketing Authorization Holder shall provide all the available details making appropriate references to the information provided by the initial reporter, in order to aid identification of the duplicate.

  • When the Local Representative or Marketing Authorization Holder is involved in relationships including those that are contractual, arrangements for meeting safety monitoring obligations shall be clearly specified in writing to the Food and Drugs Authority.

More Definitions of Marketing Authorization

Marketing Authorization means the authorization to market Finished Product in a jurisdiction issued by the appropriate Regulatory Agency in such jurisdiction.
Marketing Authorization means a Regulatory Authority approval necessary to commercially promote and distribute the Product for a Licensed Indication in the Territory including where applicable, price and reimbursement approval which must be granted for the Product to be sold in such country. Marketing Authorization as applied to any country within the Territory does not include the approval of a treatment IND, pre-approval human use trials under a protocol or distribution of a product under an emergency use program, e.g., distribution on a Named Patient Basis.
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 any Product in a country or regulatory jurisdiction in the Territory other than the United States, including applicable pricing and reimbursement approvals.
Marketing Authorization means any governmental approval by the FDA or other applicable governmental agency which is legally required under applicable laws, regulations or administrative decisions to put a pharmaceutical product on the market in such country for use in the treatment of any Indication (including pricing and reimbursement approvals, if applicable).
Marketing Authorization means the requisite governmental approval for the marketing and sale of a COMMERCIAL PRODUCT in a given country.
Marketing Authorization means an MAA that has been approved by the applicable Governmental Authority to market the applicable product in a country or group of countries.