Documentation of review of PV documents after PSUR review by EMA

[Louise Boppert]

Dear Colleagues,

Once a PSUR is approved by the EMA and there is no action to be taken with the other relevant PV documents (e.g. RMP, SmPC, PIL, label, CCDS) is it good practice to document this, and what would be the best way to document it, in a form?

Thank you for the support

[janine.gavinp82@gmail.com]

Dear PIPA Member,

Thank you for posting your question.

I would say that if you already have a regulatory tracking and archiving system or a different type of procedural tracking tool in place, then there is no reason why some kind of checklist/form cannot be implemented to show evidence that no further updates were required to the relevant PV documents. I would recommend that when a document is being written or an update to the PV document is needed, an Impact Analysis Report could be utilized to document how it was assessed that other documents did not require an update. This could then be signed off by the QPPV, Head of PV etc who is confirming  that no further updates were required and the reason why this decision was made. Should you go down this path, document this process in your local SOP.

I do hope this helps with your enquiry.

Kindest regards

PIPA

 

 

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