Guidance Documents


Paediatric Regulation: Article 45 and Article 46
 

  • Cover letter (March 2015) [.doc]
    Submission of information about paediatric studies completed after 26 January 2007 in accordance with Article 46 of Regulation No 1901/2006, as amended


Q&As Paediatric Regulation

Questions & Answers

Further Q&As have been published on the EMA website