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, deferral or waiver. Deadlines for submitting applications to the Paediatric Committee are also available below.

Table of contents


Templates and forms

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Document(s) Language Status First published Last updated Effective Date
Early paediatric interaction meeting template (English only)   16/06/2015    
Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (English only)   02/04/2013 01/04/2015  
Template for scientific document (part B-E) for application for paediatric investigation plan including deferral and waiver (English only)   15/02/2013 21/01/2015 22/04/2015
Template for notification of change of the paediatric-investigation-plan / waiver applicant / addressee (English only)   06/10/2010    
Template for letter of intent to submit an application (English only)   04/01/2010 21/01/2015 22/04/2015
Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified (English only)   28/05/2009 06/10/2015 22/04/2015
Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion (English only)   04/01/2010 26/03/2015 22/04/2015
Request for modification of an agreed paediatric investigation plan (English only)   28/05/2009 22/08/2014  
Annual report on deferral granted in the paediatric investigation plan - (PED6) certified (English only)   19/06/2000 06/10/2015  
Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified (English only)   14/06/2010 06/10/2015  
Request for confirmation of the applicability of the Agency's decision on class waivers (English only)   12/03/2010 22/08/2014  
Template letter for applicant - waiving right for a re-examination request (English only)   05/04/2016    
European Medicines Agency / PDCO summary-report template (English only)   14/12/2008 01/02/2012  
PDCO opinion template (annex I and II) (English only)   20/09/2010 16/02/2015  

Submission deadlines

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Document(s) Language Status First published Last updated Effective Date
Submission deadlines for 2014-2015 for submitting request for compliance check (English only)   23/01/2013 14/04/2015  
Submission deadlines for 2014-2015 for submitting a modification to an agreed paediatric investigation plan (English only)   23/01/2013    
Submission deadlines for 2014 and 2015 for paediatric-investigation-plan applications, applications for waivers, and answers to request for modification plan of the application (English only)   23/01/2013    
Submission deadlines for 2015-2016 for submitting a request for compliance check (English only)   10/03/2015 01/04/2015  
Submission deadlines for 2015-2016 for submitting a request for modification to an agreed paediatric investigation plan (English only)   10/03/2015 01/04/2015  
Submission deadlines for 2015 and 2016 for paediatric investigation plan applications, applications for waivers and answers to request for modification plan of the application (English only)   10/03/2015 01/04/2015  
Submission deadlines for 2016-2017 for submitting a request for compliance check (English only)   10/03/2015    
Submission deadlines for 2016-2017 for submitting a request for compliance check (English only)   10/03/2015    
Submission deadlines for 2016-2017 for submitting a request for modification to an agreed paediatric investigation plan (English only)   10/03/2015    
Submission deadlines for 2016 and 2017 for paediatric investigation plan applications, applications for waivers and answers to request for modification plan of the application (English only)   10/03/2015    
Submission deadlines for 2017-2018 for submitting a request for compliance check (English only)   10/03/2015    
Submission deadlines for 2017-2018 for submitting a request for modification to an agreed paediatric investigation plan (English only)   10/03/2015    
Submission deadlines for 2017 and 2018 for paediatric investigation plan applications, applications for waivers and answers to request for modification plan of the application (English only)   10/03/2015    

Related links

Published deadlines refer to the last acceptable day for receipt of electronic documents, either via Eudralink or on CD or DVD.