Article 15U.K.Application for renewal
1.The application provided for in Article 14 shall be submitted by a producer of the active substance to a [F1competent authority for a constituent territory in relation to which the active substance is approved], no later than three years before the expiry of the approval.
[F21A.For the purposes of this Subsection, “the assessing competent authority” in relation to an application is the competent authority referred to in paragraph 1, except where a transfer has been agreed under Article 15A(1).]
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.
[F33.The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of an application under paragraph 1.
4.A competent authority which receives a notification under paragraph 3 may request in writing from the applicant a copy of the application and any accompanying information, which the applicant must provide as soon as reasonably practicable.]
Textual Amendments
F1Words in Art. 15(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(22)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 15(1A) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(22)(b) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F3Art. 15(3)(4) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(22)(c) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)