10:13 01 Sep 24
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.
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.
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