Paediatric Worksharing

• Recommendations on submission and assessment in paediatric worksharing (December 2009)
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Paediatric Regulation: Article 45

• Best Practice Guide Article 45 - EU Worksharing procedure (Latest update: October 2009)
  Clean version click here
  Track changes click here

Paediatric Regulation: Article 46

• Best Practice Guide Article 46 - EU Worksharing procedure (Latest update: June 2010)
  Clean version Click here
  
  Track changes Click here

• Cover letter (last update: November 2008)
  Submission of information about paediatric studies completed after 26 January 2007 in accordance with Article 46 of Regulation No 1901/2006, as amended
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  Editable version: .doc

• Line listing (last update: November 2008)
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  Editable version: .xls

Public Assessment Reports

• Best Practice Guide for the preparation of the Public Assessment Report in the EU Worksharing project for the assessment of paediatric data (Latest update: March 2007)
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Paediatric Regulation: Article 29

• Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation
  (February 2009)
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Compliance statement for the agreed completed PIP

• Recommendation for implementation of compliance statement for the agreed completed PIP (September 2009)
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• Template on compliance statement for the agreed completed PIP (September 2009)
  doc. / dot.
  

PUMA

• Recommendations on Paediatric Use Marketing Authorisations (July 2009)
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Q&A Paediatric Regulation

• Questions and Answers on the Paediatric Regulation (Latest update: November 2009)
  Clean version click here
  Track changes click here