Published March 22, 2021 | Version v1
Video/Audio Open

EFSA: IUCLID Training for applicants (sessions 18/3 & 22/3)


This presentation was performed on 18/3 & 22/3 (available in PDF and .mp4) and covers the following contents:
◼ Overview of ECHA Cloud Services including registering for and accessing the full IUCLID Cloud service and the ECHA submission portal:

  • The use of Foreign entity is explained for applicants using regulatory affairs consultants or preparing a joint submission.
  • The purpose of the Legal Entity is described and the importance of maintaining legal entities for companies submitting under different EU legislations emphasised

◼ The key concepts of an IUCLID dossier:

  • Dossier header,
  • Mixture/Product dataset,
  • Active substance dataset,
  • Other substance assessment dataset,
  • Other mixture dataset.

◼ The purpose of IUCLID entities:

  • Reference substance,
  • Contact,
  • Sites,
  • Reference substance,
  • Test Material
  • Literature reference. For literature reference the use of ‘Other study identifier(s)’ to the Notification of Studies database and the separation of original and sanitised attachments is explained.

◼ Create dossier. The key steps are described:

  • + New mixture / product
  • Selecting ‘Working context’ and switching ‘Working context’ in cases where datasets are already available
  • Completing “Mixture Composition” and “Metabolites Information” documents (Reference substance with active substance function, Reference substance, only substance)
  • Accessing the datasets in the TOC.

◼ The difference between Endpoint study records, Endpoint summaries, Flexible records and Flexible summaries is explained.
◼ Complete a dossier:

  • Add new endpoint study record, include a Literature reference and Test material, set confidentiality flags, option to complete data waiving
  • Add a new endpoint summary, link to an endpoint study record
  • Add a Flexible record
  • Use of “Copy data from …” feature

◼ Use of IUCLID features:

  • Create dossier and completion of the dossier header
  • Validation assistant
  • Dissemination preview

◼ Submit a dossier:

  • Export dossier
  • Upload/submission within the submission portal

Finally, the respective Q&A sessions have been attached in .mp4 for ease of reference.


EU; MP4;


Training IUCLID for applicants.pdf

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