Dear Applicants!
For the purpose of correct processing of registration materials by the Center, we ask you to follow the recommendations on the algorithm for the movement of registration materials submitted in eCTD format:
- The registration form is filled out only in the Applicant's personal account, where the UUID is additionally indicated; it is generated in Pdf in the Applicant's account and its paper version (together with appendices) is submitted to the Service Center;
- The materials of the registration dossier are uploaded in the Applicant's personal account;
- If it is necessary to update the information in the registration form, before submitting the materials of the registration dossier, it is necessary to provide a letter to the general department through the Service Center, and when submitting the dossier to upload in the Applicant's personal account the updated registration form with all letters that were provided to it;
We also emphasize – all materials after uploading the dossier in eCTD format (responses to comments, additional materials, letters of justification regarding extension of deadlines, information letters regarding the registration form, requests for referral to the laboratory, etc.) are uploaded in the Applicant's personal account, without submitting a paper version to the Service Center.
In addition, we would like to draw your attention to the fact that the "User Guide for the Applicant's electronic cabinet" is available on the Center's website, in the For applicants section – Approved documents on the implementation of eCTD in Ukraine.
