Paediatric investigation plans: Templates, forms and submission dates

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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

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Document(s) Language Status First published Last updated Effective Date
Early paediatric interaction meeting template (English only)   2015-06-16 2017-02-16  
Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (English only)   2013-04-02 2015-04-01  
Template for scientific document (part B-F) (English only)   2013-02-15 2018-07-04 2015-04-22
Template for notification of change of the paediatric-investigation-plan / waiver applicant / addressee (English only)   2010-10-06 2017-03-21  
Template for letter of intent to submit an application (English only)   2010-01-04 2015-01-21 2015-04-22
Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified (English only)   2009-05-28 2017-05-22 2015-04-22
Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion (English only)   2010-01-04 2015-03-26 2015-04-22
Request for modification of an agreed paediatric investigation plan (English only)   2009-05-28 2018-05-28  
Annual report on deferral granted in the paediatric investigation plan - (PED6) certified (English only)   2000-06-19 2017-05-22  
Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified (English only)   2010-06-14 2017-05-22  
Request for confirmation of the applicability of the Agency's decision on class waivers (English only)   2010-03-12 2018-05-28  
Template letter for applicant - waiving right for a re-examination request (English only)   2016-04-05    
European Medicines Agency / PDCO summary-report template (English only)   2008-12-14 2012-02-01  
PDCO opinion template (annex I and II) (English only)   2010-09-20 2015-02-16