Guidance Documents

Paediatric Regulation: Article 45 and Article 46

• Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (February 2025) [Track version]

• Cover letter for Submission of information about paediatric studies completed after 26 January 2007 in accordance with Article 46 of Regulation 1901/2006, as amended (February 2025) [Track version]

• Line listing (June 2019) 

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, correction May 2024) [Track version]
• Template on compliance statement for the agreed completed PIP (December 2015)

PUMA
 

• Recommendations on Paediatric Use Marketing Authorisations (June 2018) [Track version]

Q&As Paediatric Regulation

Questions & Answers

Further Q&As have been published on the EMA website