Definition
A study which is intended to complement the data available at the time of authorization with information on the effectiveness of a drug, if questions arise that could not be clarified before the granting of the marketing authorization.
The European Medicines Agency or the European Commission may require a post-authorization efficacy study to be carried out by the holder of a marketing authorization in accordance with the requirements of Regulation No. 357/2014 of 3 February 2014.
The European Medicines Agency or the European Commission may require a post-authorization efficacy study to be carried out by the holder of a marketing authorization in accordance with the requirements of Regulation No. 357/2014 of 3 February 2014.
