Guidance Documents

Paediatric Worksharing

• Recommendations on submission and assessment in paediatric worksharing (March 2013)  [Track version]

Paediatric Regulation: Article 45

• Best Practice Guide Article 45 - EU Worksharing procedure (February 2012)  [Track version]

Paediatric Regulation: Article 46

• Best Practice Guide Article 46 - EU Worksharing procedure (September 2016) [Track version]

• 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 (November 2008) 

Paediatric Regulation: Article 29

• Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation (May 2016) [Track version]

Compliance statement for the agreed completed PIP

• Recommendation for implementation of compliance statement for the agreed completed PIP (December 2015) [Track version]
• Template on compliance statement for the agreed completed PIP (December 2015)

PUMA

• Recommendations on Paediatric Use Marketing Authorisations (February 2012) [Track version]

Q&As Paediatric Regulation

Questions & Answers

Further Q&As have been published on the EMA website