Paediatric investigation plans: questions and answers

This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.

Applicants should consult this procedural advice in conjunction with the following key document:

For general enquiries, including general information on PIP and waiver applications, modification procedures and compliance checks, please send a question to the EMA.

Submitting documents

When making submissions to the Agency, applicants should follow the guidance published on the eSubmission Gateway and eSubmission Web Client\paediatric submissions page.

Updated: EMA does not accept submissions that do not follow the published submission guidance, including Eudralink submissions.

EMA will ask applicants to resubmit their application. If the resubmission falls outside the targeted deadline, it will be not be accepted for that start of procedure.

EMA advises applicants new to the esubmission Gateway to submit their application well in advance of the targeted deadline.

Applying for a PIP, waiver or deferral

Articles 7 and 8: Definitions

Articles 33 and 35: Marketing a medicine authorised for a paediatric indication

Re-examination

Compliance statement

Modifying an agreed PIP

Request for confirmation of the applicability of the Agency decision on class waivers

PIP decisions

Transfers and changes in contact details

European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA)

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