Paediatric Data

Paediatric Regulation: Article 45

• Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006 (December 2016)

• Template for Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006(April 2014)

Paediatric Regulation: Article 46

• Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (December 2016)

• Template for Public AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006 (April 2014) 

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 (October 2014)