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RE: PIP modification to remove Studies
Yours is a case we see rarely: you would like to delete two studies from the PIP without proposing any study to replace them or any change in the other PIP studies.
The IRIS form requires at least one study to be entered and there is no way to bypass it. Thus, you could enter the details of all the studies that you request to remain in the PIP Opinion, even though you do not ask for any change in them.
In the scientific part you will send with your request of PIP modification, please make the above clear and explain what you have entered in the IRIS form and why. -
RE: PIP modification to remove Studies
In IRIS you should only include the key elements of the studies that are proposed to remain in the PIP.
You should also fill-in the form entitled "Request for Modification of an agreed Paediatric Investigation Plan", where you should specify all the requested changes, including the studies that you want to be removed and justify why. If you want to remove an entire study, you need to mention the study number in the form; you don't need to write down each key element.
Please also refer to the guidance document published on the EMA web site entitled "Procedural advice on paediatric applications". -
RE: PIP modification guidance documents
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.
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