Version in force , Modified +163 −162§
Amended by Regulation (EU) 2019/1381 32019R1381 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2021/383 32021R0383 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
The heading changes from access to the summary dossier to public access to the dossiers, and the body now refers to the dossiers referred to in Article 8, rather than the summary dossier referred to in Article 8(1), and adds any supplementary information supplied by the applicant to what is made available.
The confidentiality exception no longer refers to information for which confidential treatment was requested and justified with an override for overriding public interest, but instead refers to information to which the rapporteur Member State has granted confidential treatment under Article 63.
Cited: Art. 10, v1 (external, EUR-Lex) · Art. 10, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 14 December 2019 02009R1107-20191214 → this version, in force 27 March 2021 02009R1107-20210327
Article 10
Access Public access to the summary dossier dossiers
The Authority shall without delay make the summary dossier dossiers referred to in Article 8(1) 8, including any supplementary information supplied by the applicant, available to the public, excluding with the exception of any information in respect of to which the rapporteur Member State has granted confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure. 63.