Following receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the study reports, and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
La Commission a évalué toutes les informations fournies par le demandeur et estime que celui-ci a suffisamment démontré le respect des exigences énoncées à l'article 26, paragraphe 2, du règlement (UE) 2015/2283.