IUCLID videos on most common mistakes (part 1)

The 6 videos and a high-level description of the content are listed below.

1. Attachments and sanitisation

Add attachments to the literature reference entity:

• Study report
• MSS composer file
• Scientific publication including a citation in the sanitised attachment field

Add attachments to a Flexible Summary – Primo model excel file

Check the size and sanitisation in the attachments report

2. Components of an Active Substance Dossier

How to add the different datasests that make up a IUCLID dossier:

Complete the mixture composition document:

• “Detailed quantitative and qualitative information on the composition of the plant protection product”
• “Information on the active substance/s”
• “Information on safeners, synergists and co-formulants”

Complete the flexible summary Metabolite – “Information on metabolites”

Complete the fixed record “Other Representative Products” 

3. Analytical profile of batches

How to report the Analytical Profile of Batches

Complete the substance composition document

• Active substance – to be reported in section “Constituents”
• Impurities
• Additives

Complete the endpoint summary Analytical Profile of Batches

Check presentation of the 5-batch analysis in Document M Section 1 (Identity)

4. How the dossier is published and what an applicant should do before submission

EFSA must publish the dossier “as submitted by the applicant” after it has been declared admissible by the RMS/EMS à Submit a dossier which can be published without risking disclosure of confidential or personal data

Confidential data

• Check the filter rules when preparing the dossier
• Run dissemination preview before submitting
• Check the critical elements in the excel file

Personal data

• Double-check relevant parts of the dossier (sanitised attachments in particular)
• Find a dossier from OpenEFSA once it has been published

5. Validation rules

Use validation assistant before submitting to check the dossier is technically complete

• Resolve all business rules so that the dossier is not blocked in the submission portal
• Resolve all validation assistant warnings
• If a warning cannot be resolved provide justification in the validation assistant excel report to the RMS but this may result in a request for a dossier update and resubmission

6. Further information section completing the document

How to complete Section 3 of the active substance ToC – “Further information on the active substance”

• Complete the endpoint study record “Effectiveness against target organisms” – section 3.2
• Complete the endpoint summary “Effectiveness against target organisms” – section 3
• Complete the flexible record “Protection measures” – section 3.3

These instructions also apply to the documents in the Product dataset