Johanna Bracken

Based on this recommended practice of 'one condition per PIP submission', what will it's impact be in the circumstances where a PIP modification is required to an existing PIP which had been submitted with more than one condition already noted in the PIP? 

Thank you so much for this clarification- we will simply file the communications based on the  understanding  that no follow up action needs to be taken on our part.
Thanks again for your prompt response. Kind regards, Johanna

Dear EMA IRIS support team,
We have received a number of Notification messages  from <EMA-IRIS@id.ema.europa.eu>.
The messages are in acknowledgement of PIP modification submissions, however they  relate to previously approved PIP modifications and not recently submitted information.
It would be helpful if you can explain why we are receiving such messages-  does it relate to testing of EMA's communication system via IRIS?

Please advise if these messages are to be treated as 'FYI' and require no further action from the sponsor.
With thanks,
Johanna

When using IRIS, it appears that the section on Scientific information – drop down menus do not accommodate sufficiently for sPIP application as certain information remains unknown based on the nature of stepwise PIP process e.g. potential controls are unknown at this time but drop down menu only allows for set selection of controls to be chosen and does not have category for ‘unknown’
Planned submission date is also undetermined as per nature of sPIP but calendar date needs to be entered.
It seems that for an sPIP application,  there are challenges posed by the requirement to 'Please provide all details on each proposed study/measure to be included in the new PIP Decision. Please provide advice on how to progress with an sPIP application when data may be deficient at time of submission. Thank you.