PIP modification guidance documents

We have an existing PIP approved ex-IRIS

We are now looking to submit a modification submission. Having set up a new draft submission I am working my way through the information required to complete the various screens, however most of the information being requested does not seem to directly relate to a modification but seem more in line with an initial PIP submission. This is making it difficult to complete mandatory fields since there is no context  in relation to a modification e.g. list the proposed indication - we are not proposing a new indication, we are trying to modify KBE of an existing PIP ??

I have looked at the IRIS for applicants document and the procedural advice document, however neither of these documents provide any detail on complete the individual fields. Hovering over these fields does in some cases provide a brief explanation, but again this appears in the context of an initial submission and not a modification. Is there any other guidance document or training that provides this more detailed information? 

 

In the various fields of the IRIS form you need to enter the regulatory and scientific information applicable to your procedure. What to enter is in most cases self-explanatory. For example, you must enter the condition your application refers to, even if you do not request to modify it. Same for the paediatric indication. If you request changes to a certain element of the PIP, you need to enter it as you would like it to be in the future PIP Opinion.

For guidance on modification procedures, please refer to section 5.2 (Modification of an agreed paediatric investigation plan (PIP)) of the document entitled Procedural advice on paediatric applications, where, among other things, it is specified that “Key elements must be completed in the IRIS portal. Include only the proposed modified key elements. If a key element is not changing please add N/A in the mandatory field”.

Please also refer to the document entitled “Paediatric investigation plan (PIP) - Key elements guidance”

You can find guidance on how to apply for paediatric procedures here.

We have done one PIP Annual report and are doing a PIP modification. We have reported to the EMA that the button "generate form" does not generate a form with the data of the PIP included instead it generates a form that is called ODD and that does not include all fields filled in by the submitter/ sponsor. 

The EMA has advised that this button will be removed for PIP submissions. We do worry about this as this button is the ONLY way to get the fields filled into the KEF form out of IRIS. The Submitter / Sponsor would require to store the information submitted and if the EMA would remove the button "generate form" this is very difficult. Could the EMA fix the button so that when we generate the form in IRIS this would include the information the Submitter / Sponsor has filled in in the IRIS platform for their PIP submissions?