in force 2021-03-27 MODIFIED+316 −102§
Amended by Regulation (EU) 2019/1381 32019R1381 · Regulation (EU) 2021/383 32021R0383
applies from: unchanged
The heading changes from "Access to the information for renewal" to "Public access to the information for renewal".
The article now states that the Authority shall assess any confidentiality request without delay and make available the applicant's Article 15 information plus any other supplementary information submitted, excluding only information for which confidential treatment has been requested and granted by the Authority under Article 63, replacing the earlier wording that excluded information for which confidential treatment had merely been requested and justified under Article 63 unless there was an overriding public interest in disclosure.
A new paragraph is added stating that the Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.
Cited: Art. 16, v1 · Art. 16, v2
text before / after
02009R1107-20191214 → 02009R1107-20210327
Article 16
Access Public access to the information for renewal
The Authority shall, shall assess, without delay, any confidentiality request and make available to the public the information provided by the applicant under Article 15, excluding 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and justified granted by the Authority pursuant to Article 63, unless there is an overriding public interest in its disclosure. 63.
The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.