CRAD BLOG

BRIEF UPDATE ON KKDIK REGISTRATION PROCESS AND ASSIGNMENT OF LEAD REGISTRANT (LR)

Recently MoEU had published an announcement giving some details and guidance on the LR assignment with in the KKDİK SIEF Structures and conditions on individual submission. 

Please find below the bullet points from this briefing; 

  • When a SIEF concludes the identification of the Lead Registrant (LR), the LR submits a statement on this via KKS. When this is approved by the Competent Authority (CA) no other SIEF member can make an assignment as LR for the same substance and the LR can not resign from the LR role. If a case rises regarding the LR to resign from the role, this should be submitted formally to the CA for the case to be assessed and decided by the CA. The submission of LR assignment via KKS will start as of 15 February 2021 and any earlier assignments will be disregarded. 


CRAD’s comment: The CA still not yet decided what will be accepted as proof of acceptance of the LR by the SIEF communication so there is a gap here about the conditions to be accepted/rejected as a LR in case of conflicts.

  • The LR should first contact with all members of the SIEF prior to submitting a LR assignment via KKS. As well the LR should keep the communication live even after LR assignment for the late pre-registrants to be included in the SIEF communication loop too. 
     
  • When the LR assignment is completed; the members of the SIEF will be able to view ‘’who the LR is’’ via the KKS system. 
     
  •  After the LR assignment the dossier submission tool will be enabled for the LR. 
     
  • Companies who wish to submit an individual submission should apply the CA formally (with a hard copy dossier submission) along with the reasons for Individual Submission. After the Review of the CA if Individual Submission is approved by CA the Individual submission tool will be enabled for the Company. 
     
  • Individual submitters are also obliged to share the data they own with the SIEF. In contrary CA can apply enforcement measures.   


Source: Help Desk web page of MoEU.

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