Paediatric requirements for variations and extensions to marketing authorisations

Applications for new indications, new pharmaceutical forms or new routes of administration concerning an authorised medicine protected either by a supplementary protection certificate or by a patent that qualifies for the granting of such a certificate 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 regarding variations applications, see question 17 of Type-II variations: questions and answers: Do I need to address any paediatric requirements in my type-II variation application?

For more information regarding extension applications, see question 14 of the Extension applications: questions and answers: Do I need to address any paediatric requirements in my extension 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.

For guidance on the compliance check, see Paediatric requirements for marketing-authorisation applications.


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