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 use AskEMA. The paediatrics ( inbox is no longer in use (as of 31 May 2020).

Submitting documents

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. Applicants should follow the revised guidance on paediatric submissions published on eSubmission\paediatric submissions page.

EMA does not accept submissions that do not follow the published guidance on paediatric submissions, including using the correct submission channel.

Update: Applicants should note that the xml delivery files for paediatric submissions is changing in on 19 November 2020. An overview of changes is provided in the following presentation, with further information in an updated guidance on paediatric submissions valid from 19 November 2020.

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

1. Applying for a PIP, waiver or deferral

2. Articles 7 and 8: Definitions

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

4. Re-examination

5. Compliance statement

6. Modifying an agreed PIP

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

8. EMA decisions on PDCO opinions

9. Transfers and changes in contact details

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


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