The employment of the fresh xml delivery file for distribution to the PSUR Data source are necessary for everyone PSURs and one associated distribution through the eSubmission Portal and you may/or even the Internet Client. PSURs and you can one relevant articles by using the established document naming events are no expanded you are able to. The mandatory utilization of the PSUR xml delivery document was put so you’re able to harmonise the brand new submission mechanism for all PSURs and it also is applicable to all or any form of PSURs and you can any associated submissions. For additional rules with the creation of new xml beginning document, excite consider new MAH PSUR Data source Associate Suggestions file.
The state contact person with the PSUR procedure is certainly one considering throughout the xml birth document. This person will be the just recipient of any communication out-of EMA throughout the this process, such as the PRAC Recommendation, CHMP/CMDh production, and you can Commission Decision, since applicable. Read More