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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)

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