European Medicines Agency updates Questions and answers on the Paediatric Regulation

European Medicines Agency updates Questions and answers on the Paediatric Regulation (Regulation of the European Parliament and of the Council (EC) no 1901/2006, as amended)

Response to question no 13 has been updated. Track change version of guidance can be found in below link.

https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_007_2007_Rev10_2021_03_TC_-_Q_A_on_the_Paediatric_Regulation_TC.pdf