Paediatric requirements for marketing-authorisation applications

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 the relevant section on paediatric requirements in the Pre-authorisation guidance.

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.

Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards

AdoptedLegal effective date: 08/06/2011Reference Number: EMA/PDCO/179892/2011 Rev. 2

Standard operating procedure for compliance check of an agreed paediatric investigation plan

AdoptedLegal effective date: 15/12/2017Reference Number: SOP/H/3456

• General guidance, templates and forms and deadlines for submission