in force 2021-03-27 MODIFIED+509 −92§
Amended by Regulation (EU) 2019/1381 32019R1381 · Regulation (EU) 2021/383 32021R0383
applies from: unchanged
Paragraph 1 now adds a requirement that applications be submitted in accordance with standard data formats where they exist under Article 39f of Regulation (EC) No 178/2002, applied mutatis mutandis, alongside references to the dossier and approval criteria now specifying 'of this Regulation'.
Paragraph 3 changes the confidentiality request wording from a request to keep information confidential to a request to treat it as confidential, and now specifies that the rapporteur Member State decides after consultation with the Authority and in accordance with Article 63, rather than simply deciding upon a request for access.
Paragraph 3 also adds a new sentence stating that the Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.
Cited: Art. 7, v2 · Art. 7, v1
text before / after
02009R1107-20191214 → 02009R1107-20210327
Article 7
Application
1. An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, State (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. 4 of this Regulation. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.
2. Assessment of an application may be performed by a number of Member States together under a co-rapporteur system.
3. When submitting the application, the applicant may submit a request, pursuant to Article 63 request 63, to treat certain information, including certain parts of the dossier, to be kept as confidential and shall physically separate that information.
Member States shall assess the confidentiality requests. Upon a request for access to information, After consultation with the Authority, the rapporteur Member State States shall decide what information is to be kept confidential. treated as confidential, in accordance with Article 63.
The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.
4. When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59.
5. When assessing the application the rapporteur Member State may at any time consult the Authority.