24. Ideas on how to choose the official contact person on the PSUR?
The utilization of the new xml birth file for articles towards the PSUR Repository try compulsory for everyone PSURs and any related submissions via the eSubmission Gateway and you can/and/or Net Consumer. PSURs and any related articles utilizing the present file naming exhibitions are no lengthened you can. The mandatory utilization of the PSUR xml delivery file is actually introduced so you can harmonise new submitting device for everyone PSURs and it also can be applied to all the type of PSURs and you can any relevant submissions. For further tips toward creation of the newest xml delivery document, delight reference the fresh MAH PSUR Repository Representative Guidance document.
The state contact people towards PSUR processes is the one considering about xml delivery document. This person may be the sole receiver of any interaction from EMA throughout this method, for instance the PRAC Testimonial, CHMP/CMDh yields, and Payment Decision, because the applicable. Brand new contact details provided about xml delivery document will always bypass any guidance offered regarding cover letter.
25. Exactly what fee do I have to shell out? Rev.

To your PSUR investigations lower than a beneficial PSUSA process involving over one to MAH, the amount of the cost is split up one of most of the the latest MAHs alarmed proportionately to your number of chargeable gadgets.
The latest MAHs alarmed was situated in line with the obligation to submit the fresh PSUR(s) and never according to the actual PSUR distribution(s) acquired by 1r3n nainen EMA.
The off chargeable gadgets in the process could be identified on the Ways. 57 databases. The fresh display payable by per marketing authorisation will be computed because of the the EMA. A recommendation notice might possibly be produced during the analysis secure part (DLP) date and you can delivered correctly to your associated QPPVs so you’re able to guarantee the exact personality of one’s chargeable tools to the situations active in the processes.