1. Relevant information to this application
EMA PIP number (latest agreed PIP):
EMA decision number (latest agreed PIP): Dated:
(A copy of the EMA decision should be annexed)
2. Reasons for applying for a modification of the Agency's decision
(Please provide the main reasons in the table below [ref. Art. 22]. The detailed scientific justification should be elaborated in the separate scientific documentation (Parts B-E). Tick all that apply.)
A.
Is the modification required for administrative changes?
Yes No
B.
Is the modification required for changes in either measures or timelines as stated in the decision?1
Yes No
If yes, please specify:
New/changed waiver request:
New/changed condition or indication to be waived
Change in subset(s) of the paediatric population, pharmaceutical form(s) and route(s) of administration covered
Changes in the deferral(s) (e.g. new deferral[s] asked)
Changes in the PIP measures as stated in the decision:
Additional new condition/indication to be investigated
1 Modifications may not be necessary for changes that increase the scientific strength as per the current key binding elements, e.g., double-blind instead of open-label study, or changes that would no impact compliance check, such as “210 patients evaluable” when the key binding element was “At least 175 evaluable patients”.
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Modification of condition/indication to be investigated
Modification of subset(s) covered
Modification of key binding elements (not time lines) of studies/measures
Changes in the timelines for initiation/completion of studies
Other (please specify: )
3. List of the modification(s) of the measures and timelines as stated in the Decision
One table per study – one row per key element to be modified. Only include studies where key elements are to be modified, and only include those key elements; add more lines in the table, if necessary. If a whole study is to be deleted or a new one inserted, just write “study deleted” or “study added” after study N./identifier; justifications and PDF Studies file also to be provided accordingly.
Study N. and identifier:
Current key binding element
Copy the exact wording of the agreed elements from the previous PIP opinion.
Please use a separate line for each key element
Do not include elements that you do not wish to change
Proposed change(s)
Please reword the key binding element as desired for the new opinion.
Do not include any explanation in this column.
Justification for change (max. 250 words)
Include a concise justification only; use the scientific document (Parts B-
E) for more extensive justification if necessary.
4. Part(s) of the scientific documentation that have been modified and are submitted (B to F)
Please indicate which are all the revised sections of the documentation (tick all that apply)
Part A; please specify the relevant sections
Part B; please specify the relevant sections
Part C; please specify the relevant sections
Part D; please specify the relevant sections
Part E; please specify the relevant sections
Part F
Date:
Name on Signature:
Request for Modification of an agreed Paediatric Investigation Plan
EMA/264007/2011 Page 2/2