Module232025

07/05/2025

PIP Modification request form Add rows and comment boxes as needed. Ensure a separate row for each key binding element followed by a comment box. In case of new study list all key binding elements and add “Study to be added”.

Study N. and identifier:

Current key binding element

Proposed change(s)

Justification for change Provide a concise and comprehensive explanation for each proposed change. Additional information can be provided in a separate document only when necessary (e.g. including graphs or tables).

Change the key binding element as desired, where possible highlight the change (e.g. bold font, highlight, strike through but do not use track-changes.

Copy the exact wording of the key binding element you request to change from the Annex I of the preceding opinion.

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

The Organisation for Professionals in Regulatory Affairs

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Procedure for modification of an agreed PIP

No formal validation: if application is incomplete / insufficiently justified, risk of negative opinion (but possible to withdraw) Clarifications and interactions possible after D30 Summary Report. However, opinion at D30 possible Opinion adopted: positive even if only one of the modifications requested has been accepted New opinion replaces previous opinion and contains all key binding elements, not just those modified Opinion and decision process is the same as for original opinion (EMA decision; re-examination possible).

From P. Tomasi, EMA

The Organisation for Professionals in Regulatory Affairs

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