24. Tips identify the state get in touch with person into PSUR?
The utilization of the latest xml delivery apply for submissions on PSUR Databases are necessary for everybody PSURs and you will one associated submissions through the eSubmission Portal and you will/and/or Web Visitors. PSURs and you will people related articles by using the present file naming conventions are not any lengthened you’ll be able to. The required use of the PSUR xml delivery file try lead so you’re able to harmonise the new submission device for everyone PSURs and it also applies to any or all sort of PSURs and you will any associated articles. For additional guidelines to your production of the newest xml beginning file, delight reference the new MAH PSUR Databases Associate Guidance document.
The official contact individual towards the PSUR techniques is but one considering from the xml beginning file. This individual is the only receiver of every communication out-of EMA throughout this technique, for instance the PRAC Recommendation, CHMP/CMDh efficiency, and Commission Decision, given that applicable. This new contact details given regarding xml birth file are always bypass one recommendations provided about cover letter.
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With the PSUR review not as much as an excellent PSUSA process involving more than you to definitely MAH, the amount of the price tag is divided among every brand new MAHs worried proportionately toward number of chargeable gadgets. (tovább…)
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