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).