Paediatric investigation plans: Templates, forms and submission dates
HumanRegulatory and procedural guidancePaediatricsResearch and development
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.
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.
Submission deadlines
EMA has revised the deadlines for paediatric applications to allow for any type of submission. This has affected submission deadlines in June 2020, September 2020 and June 2021, as well as the dates of the PDCO plenary in September 2020.
Applicants should observe the revised deadlines when preparing paediatric submissions.
Templates and forms
Important
The forms and templates should be downloaded and saved first before being completed. To report any technical issues with the form, please use the EMA Service Desk portal.
It is mandatory to use the latest published version of all templates and forms unless stated otherwise. Please do not re-use previously downloaded documents.
A new scientific document template is published and should be used from now on. Paediatric investigation plan submissions drafted using the old template will be accepted until 25 March 2024.