Completeness Check
Submission incomplete:
1.There is an inconsistency in the cross-referencing of the post-registration changes. The issuance request form, monitoring report and verification/certification report refer to post-registration change type temporary deviation whereas the submission does not include a post-registration change and there are no related documents submitted.


2.There is an inconsistency in the cross-referencing of the monitoring report template. The submitted monitoring report is in form version 9 whereas the verification and certification report on page 9 refers to monitoring report form version 8.


3.The submission is based on VVS version 2 which is no longer valid.



4.Scope: The cross-referencing and versioning within and between the document are not correct and accurate.


Issue: There is an inconsistency in the cross-referencing of the monitoring report. The verification and certification report on page 50 refers to monitoring report version 1, on pages 33 and 39 refers to MR version 2, and on pages 65 and 100 refers to MR version 4 dated 07/06/2021 whereas the applicable monitoring report is version 4 dated 08/02/2022.