The use of the newest xml delivery apply for articles toward PSUR Databases is mandatory for everyone PSURs and people relevant distribution through the eSubmission Gateway and you can/or the Internet Buyer. PSURs and people associated distribution making use of the current document naming exhibitions are no stretched possible. The mandatory utilization of the PSUR xml birth file try brought so you’re able to harmonise the newest submission process for everyone PSURs and it also applies to all form of PSURs and one associated distribution. For additional tips towards production of the fresh new xml birth document, please refer to brand new MAH PSUR Repository Member Pointers file.
The official contact person with the PSUR procedure is but one provided in the xml delivery document. This person may be the best recipient of any interaction out-of EMA during this process, including the PRAC Recommendation, CHMP/CMDh production, and you can Fee Choice, just like the relevant. The latest contact info given from the xml beginning file will always be override people guidance given throughout the employment cover letter.
twenty five. Just what fee manage I need to shell out? Rev.
On the PSUR comparison lower than good PSUSA process associated with more you to definitely MAH, the quantity of the fee will be split certainly the new MAHs alarmed proportionately to your number of chargeable gadgets.
The fresh new MAHs worried would-be depending in line with the obligation to submit the brand new PSUR(s) and never based on the real PSUR submitting(s) obtained by the EMA.
The total out-of rechargeable systems in the procedure is understood about Artwork. 57 databases. This new show payable because of the for every product sales authorisation is computed of the the latest EMA.
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