Paediatric investigation plans: Templates, forms and submission dates

This page lists the templates and forms required by companies wishing to apply for a paediatric investigation plan (PIP), deferral or waiver. Deadlines for submitting applications to the Paediatric Committee (PDCO) are also available below.

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. For more information, see the revised submission guidance for applicants.

Update: 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.

For general information on how to apply for a PIP, waiver or deferral, see Paediatric investigation plans: questions and answers.

Synchronised submission deadlines

EMA has synchronised the submission deadlines for paediatric procedures, to streamline the process for applicants and the PDCO. This will enable the PDCO to hold its August plenary meetings by written procedure. A new submission deadline document replaces the three pre-existing ones.

From July 2018, these submission deadlines will cover all paediatric procedures, unless otherwise specified. However, procedure-specific deadlines will continue to apply in May and June of each year.

Templates and forms

How useful was this page?

Add your rating
Average
1 rating
1 rating