Paediatric requirements for marketing-authorisation applications

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Applications for marketing authorisation submitted to the European Medicines Agency (EMA) that concern medicines not authorised in the European Union (EU) on 26 July 2008 must include the results of studies carried out as part of an agreed paediatric investigation plan (PIP) or information on a PIP deferral or waiver.

For more information, see question 59 of the Pre-submission guidance: questions and answers: 'Do I need to address any paediatric requirements in my application?'

Compliance check

Applicants can request that a PIP compliance check is carried out before submitting a marketing-authorisation application. Alternatively, compliance check will be carried out as part of the validation of the application. Applicants are strongly recommended to apply for the compliance check before submission of the marketing-authorisation application to not delay the validation phase.

This check verifies that all the measures mentioned in the PIP decision, including the timelines for the conduct of the studies or collection of the data, have been completed in accordance with the key elements specified in the PIP decision.

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards (English only) adopted 08/03/2011 21/01/2015 08/06/2011
Standard operating procedure for compliance check of an agreed paediatric investigation plan (English only) adopted 26/05/2010 09/10/2015 05/10/2015