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

Please note that if you wish to submit a post-registration change along with this request you must submit the relevant post-registration change documents.


2.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 32 refers to monitoring report version 5 dated 3/3/2022 whereas the applicable monitoring report is version 5 dated 19/2/2022. Kindly clarify.