08:04 27 Dec 24
Completeness Check
Submission incomplete:
1.The post-registration changes form is not submitted.
2.The DOE is requested to submit the respective validation report for post-registration changes using the valid version of the applicable validation report form for post-registration changes, taking into account the grace period of the form if it has been revised as per VVS version 01.0 paragraph 21 and 250.
3.2. The verification/certification report on page 15 section E.3.2.1 and monitoring report on page 15 section C.3.1 refer to post-registration changes "Temporary deviations" however, no reference is made to PRC in the signed form and no PRC is submitted with this request for issuance.
4.1. There is an inconsistency in the cross-referencing of the monitoring report. The verification/certification report refers on page 27 to monitoring report version 4 dated 07/06/2019 whereas the applicable monitoring report is dated version 4 dated 27/05/2020. Kindly clarify.
1.The post-registration changes form is not submitted.
2.The DOE is requested to submit the respective validation report for post-registration changes using the valid version of the applicable validation report form for post-registration changes, taking into account the grace period of the form if it has been revised as per VVS version 01.0 paragraph 21 and 250.
3.2. The verification/certification report on page 15 section E.3.2.1 and monitoring report on page 15 section C.3.1 refer to post-registration changes "Temporary deviations" however, no reference is made to PRC in the signed form and no PRC is submitted with this request for issuance.
4.1. There is an inconsistency in the cross-referencing of the monitoring report. The verification/certification report refers on page 27 to monitoring report version 4 dated 07/06/2019 whereas the applicable monitoring report is dated version 4 dated 27/05/2020. Kindly clarify.
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