Forms and templates

Pre-submission interaction letter of intent form

Reference Number: Version 1.0.4 Legal effective date: 22/04/2015 Summary:

Pre-submission interaction letter of intent form

English (EN) (119.86 KB - PDF)

First published: 04/01/2010 Last updated: 04/10/2018

Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified

Legal effective date: 22/04/2015

English (EN) (269.72 KB - PDF)

First published: 28/05/2009 Last updated: 11/10/2021

Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion

Reference Number: EMA/283362/2012 Version 7

English (EN) (283.61 KB - DOCX)

First published: 04/01/2010 Last updated: 08/08/2025

Annual report on deferral granted in the paediatric investigation plan - (PED6) certified

Reference Number: Version 1.0.6

English (EN) (171.63 KB - PDF)

First published: 19/06/2000 Last updated: 22/05/2017

Template to change applicant name or details

English (EN) (36 KB - DOC)

First published: 04/01/2010 Last updated: 21/03/2017

Request for modification of an agreed paediatric investigation plan

English (EN) (32.2 KB - DOCX)

First published: 28/05/2009 Last updated: 26/11/2025

Request for confirmation of the applicability of the Agency's decision on class waivers

English (EN) (103.26 KB - DOCX)

First published: 12/03/2010 Last updated: 20/03/2019

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