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Posted Mon, 03 Mar 2025 14:25:50 GMT by Gina Pereira
Could you please confirm if the EMA will no longer issue the procedure number as we currently know it ( e.g. EMEA/H/C/00xx/Variation type/xxxx)? Is the procedure number being replaced by the submission number generated by IRIS?
Posted Thu, 06 Mar 2025 14:36:11 GMT by Paolo Tomasi EMA
Yes, your understanding is correct. 
Posted Fri, 11 Apr 2025 10:13:02 GMT by HRISHIKESH DHONGADE
Thank you for your reply. 
I have one more query. In line with section 14.1 of the IRIS guide for applicants v3.7, should we begin using this Submission Case number in the format defined in the procedure tracking number field for initial submission units, and then subsequently swap them with the actual submission number created by IRIS?
 

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