Completeness Check
Submission incomplete:
1.Scope: The monitoring period throughout the documentation is not consistent.
Issue: There is an inconsistency in the cross-referencing of the monitoring period. The verification/certification report on page 46 refers to period 01/01/2018 31/03/2020 whereas the applicable monitoring period is 01/01/2018 31/03/2019.


2.Scope: Cross-referencing and versioning within and between the document is not correct and accurate.
Issue: There is an inconsistency in the cross-referencing of the PDD completion date. The validation report for post-registration changes refers on page 13 to PDD version 7.1 dated 02/12/2012 whereas the applicable PDD is dated 02/10/2012.