Paediatric investigation plans: Templates, forms and submission dates
Table of contents
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.
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.
Important
The forms and templates should be downloaded and saved first before being completed, using for example “Save target as” function. To report any technical issues with the form, please use the EMA Service Desk portal.
An improved key elements form, which applicants must use from 12 September 2023, is available below.
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Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion - September 2023 (DOCX/148.46 KB)
First published: 09/06/2023
Legal effective date: 12/09/2023
Version 1.1.1 -
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Notification of discontinuation of an agreed PIP decision (DOC/40 KB)
First published: 02/04/2013
Last updated: 09/04/2019 -
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Template for scientific document (part B-F) (DOC/318 KB)
First published: 15/02/2013
Last updated: 20/03/2019 -
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Form: Notification of change for paediatric procedures (PDF/4.08 MB)
First published: 03/11/2020 -
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Pre-submission interaction letter of intent form (PDF/119.86 KB)
First published: 04/01/2010
Last updated: 04/10/2018
Legal effective date: 22/04/2015
Version 1.0.4 -
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Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified (PDF/269.72 KB)
First published: 28/05/2009
Last updated: 11/10/2021
Legal effective date: 22/04/2015 -
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Request for modification of an agreed paediatric investigation plan (DOC/58.5 KB)
First published: 28/05/2009
Last updated: 04/10/2018 -
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Annual report on deferral granted in the paediatric investigation plan - (PED6) certified (PDF/171.63 KB)
First published: 19/06/2000
Last updated: 22/05/2017
Version 1.0.6 -
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Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified (PDF/176.39 KB)
First published: 14/06/2010
Last updated: 22/05/2017
Version 1.0.8 -
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Request for confirmation of the applicability of the Agency's decision on class waivers (DOCX/103.26 KB)
First published: 12/03/2010
Last updated: 20/03/2019 -
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Template letter for applicant - waiving right for a re-examination request (DOC/25 KB)
First published: 05/04/2016
Last updated: 20/03/2019 -
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European Medicines Agency / PDCO summary-report template (DOC/434 KB)
First published: 15/12/2008
Last updated: 20/03/2019 -
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PDCO opinion template (annex I and II) (DOC/264.5 KB)
First published: 20/09/2010
Last updated: 20/03/2019