Paediatric Data

Paediatric Regulation: Article 45

• Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006 (April 2025) [Track version]

• Template for Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006 (June 2022)

Paediatric Regulation: Article 46
 

• Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (April 2025) [Track version]

• Template for Public AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (June 2022) 

Comments from the Competent Authority on the Paediatric work sharing  Assessment Reports

 

• Member states comments on the Paediatric Work Sharing assessment reports for Article 45 and Article 46 (February 2025) [Track version]