IUCLID videos on most common mistakes (parts 1 & 2)

The 12 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

7. Completing the flexible summaries in the residues section

Complete the endpoint summary of Stability of residues in stored commodities – section 6.1

• Complete the endpoint summary metabolism of residues in plants and rotational crops –section 6.2.1 
• Complete the endpoint summary metabolism of residues in livestock –section 6.2.2
• Complete the endpoint summary magnitude of residues in plants –section 6.3 
• Complete the flexible summary “Feeding studies” – section 6.4
• Complete the endpoint summary  Nature and Magnitude of residues in processed commodities 6.5 
• Complete the flexible summary “Proposed residue definitions” – section 6.7.1
• Complete the flexible summary “Proposed maximum residue levels” – section 6.7.2
• Complete the flexible summary “Estimation of the potential and actual exposure through diet and other sources” – section 6.9

8. Legal Entity

Use of legal entities in PPP dossiers and in the Submission Portal

• What is a Legal Entity
• Where are legal entities are used in the dossier
• The role of Legal entities in the submission Portal

9. Requesting confidential treatment

• Clear identification of the information claimed confidential and its location
• Identification of the legal basis of the request
• Submission of a compliant justification for the request

10. Analytical methods (also for Section 5 of the Product dataset)

• How to complete the Endpoint Study Record “Analytical methods”
• How to cross-reference the analytical methods in the corresponding studies
• How to generate Document M – Section 4 (Analytical methods) using Report Generator

11. Assessment by other authorities

The document is in the summary and evaluation section

• How to report information on Assessments in Europe and Assessments Outside Europe
• How to report information on existing MRLs
• How to provide additional information ONLY for Import Tolerance applications

12. Dossier submission

• Ensure that all the pre-submission checks are carried out to enable a successful submission
• Create and export a dossier
• Submit a dossier
• Successfully re-submit a dossier