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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

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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