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3.2.1: About CMDh (ALT-O)
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3.2.10: Paediatric Regulation (ALT-N)
- 3.2.10.1: Guidance Documents
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3.2.14: What's new history (ALT-W)

Paediatric Worksharing

Recommendations on submission and assessment in paediatric worksharing (October 2010) [Track version]

Paediatric Regulation: Article 45

Best Practice Guide Article 45 - EU Worksharing procedure (July 2010) [Track version]

Paediatric Regulation: Article 46

Best Practice Guide Article 46 - EU Worksharing procedure (June 2010) [Track version]

Cover letter (November 2008) [.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) [.xls]

Paediatric Regulation: Article 29

Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation (October 2010) [Track version]

Compliance statement for the agreed completed PIP

PUMA

Recommendations on Paediatric Use Marketing Authorisations (July 2009)

Q&As Paediatric Regulation

Questions and Answers on the Paediatric Regulation (January 2011) [Track version]

Further Q&As have been published on the

EMA website