15:59 10 Feb 25
Completeness Check
Submission incomplete:
The issuance request form, the monitoring report and the verification/certification report refer to a post registration change (temporary deviation) however, there is no post registration changes submitted with this request for issuance. We understand that the applicable period for proposed deviations is 11 Mar 2019 - 03 Oct 2019 and technically this would only be applicable under MP 01 Jan 18 - 31 Dec 20. However, being a TM Twin case, although this TDEV is not applicable for MP 01 Jan 21 - 09 Jul 21, on the ground that same set of docs need to be submitted this request for issuance will be marked as incomplete.
The issuance request form, the monitoring report and the verification/certification report refer to a post registration change (temporary deviation) however, there is no post registration changes submitted with this request for issuance. We understand that the applicable period for proposed deviations is 11 Mar 2019 - 03 Oct 2019 and technically this would only be applicable under MP 01 Jan 18 - 31 Dec 20. However, being a TM Twin case, although this TDEV is not applicable for MP 01 Jan 21 - 09 Jul 21, on the ground that same set of docs need to be submitted this request for issuance will be marked as incomplete.
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