Paediatric investigation plans: Templates, forms and submission dates

  • Email
  • Help

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

Back to top

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-E) for application for paediatric investigation plan including deferral and waiver (English only)   2013-02-15 2015-01-21 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 2014-08-22  
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 2014-08-22  
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  

Submission deadlines

Back to top

Document(s) Language Status First published Last updated Effective Date
Submission deadlines for 2016-2017 for submitting a request for compliance check (English only)   2015-03-10    
Submission deadlines for 2016-2017 for submitting a request for compliance check (English only)   2015-03-10    
Submission deadlines for 2016-2017 for submitting a request for modification to an agreed paediatric investigation plan (English only)   2015-03-10    
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)   2015-03-10    
Submission deadlines for 2017-2018 for submitting a request for compliance check (English only)   2015-03-10    
Submission deadlines for 2017-2018 for submitting a request for modification to an agreed paediatric investigation plan (English only)   2015-03-10    
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)   2015-03-10    

Related links

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