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, 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

In March 2012, Celltrion submitted its Marketing Authorization Application to the EMA.

Recommendations: The CPC recommends that FDA clarify that Combination Product Marketing Authorization Holders are accountable for product quality, but would not be required to maintain CAPA procedures, or any other manufacturing procedures, unless they are actually manufacturing products.

That’s because PRIME products can benefit from EMA interactions during later development and may be eligible for accelerated assessment during the Marketing Authorization Application (MAA) review process.Companies seeking to launch new treatments in Europe need to decide which HTA bodies to approach.The HTA landscape in Europe encompasses more than 50 different agencies in 27 EU member states at the national, regional, and local levels.

These EUnetHTA Rolling Collaborative Reviews are not meant to substitute a joint Relative Effectiveness Assessment (REA) adhering to the agreed procedures, aiming at critical appraisal of the clinical evidence based on the Submission Dossier submitted by the Marketing Authorization Holder (MAH).


More Definitions of Marketing Authorization

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 in the United States means final approval of an NDA, sNDA or BLA permitting marketing of such Product in interstate commerce in the United States; and (b) “Marketing Authorization” in Europe means marketing authorization for such Product granted either by a Regulatory Authority in any country in Europe or by the EMA pursuant to Council Directive 2001/83/EC, as amended, or Council Regulation 2309/93/EEC, as amended.
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 receipt of all approvals from the relevant Regulatory Authority necessary to market and sell a Product in the United States (including all applicable approvals or determinations by a Regulatory Authority for the pricing or pricing reimbursement for a pharmaceutical product even if not legally required to sell the Product in the United States).