Article 11a F1

For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605^f1, in relation to applications submitted in accordance with Article 1 before 10 November 2018 for which the draft renewal assessment report has not been submitted by that date, where the information available in the supplementary dossiers is not sufficient for the F2assessing competent authority to conclude the assessment on whether these approval criteria are met and, where applicable, whether application of Article 4(7) is justified, the assessing competent authority shall specify in the draft renewal assessment report, in a detailed way, the additional information which is necessary in order to make the assessment concerned.