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
- Line listing (June 2019)
Paediatric Regulation: Article 29
Compliance statement for the agreed completed PIP
PUMA