Completeness Check
Submission incomplete:
1.The request for issuance form is not signed.


2.Appendix 2 of the validation report for post-registration changes and appendix 2 of the verification/certification report are not completed.


3.The revised PDD (in track changes) submitted for post-registration changes does not indicate the track change mark-ups of the PDD, including the version number and date on page 1.



4.There is an inconsistency in the cross-referencing of the post-registration changes. The post-registration changes submission page, the post-registration changes request form, the validation report for post-registration changes and verification/certification report refer to post-registration type: corrections and permanent changes whereas the monitoring report refers to temporary deviation and permanent changes.