in force 2021-03-27 MODIFIED+229 −22§
Amended by Regulation (EU) 2019/1381 32019R1381 · Regulation (EU) 2021/383 32021R0383
applies from: unchanged
The reference to Article 14 is now specified as Article 14 of this Regulation, and the order in which copies are listed changes to the Commission, then the other Member States, then the Authority.
A new sentence is added stating that 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.
Cited: Art. 15, v1 · Art. 15, v2
text before / after
02009R1107-20191214 → 02009R1107-20210327
Article 15
Application for renewal
1. The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the Commission, to the other Member States, the Commission States and to the Authority, no later than three years before the expiry of the approval.
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.
2. When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval. The applicant shall at the same time submit a timetable of any new and ongoing studies.
The applicant shall identify, giving reasons, the parts of the information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data protection claims pursuant to Article 59.