Article 7U.K.Application
[F11.An application for the approval of an active substance may be submitted by the producer of the active substance to a competent authority.
1A.An application for an amendment to the conditions of an approval may be submitted by the producer of the active substance to a competent authority for a constituent territory to which the approval applies.
1B.A joint application may be submitted under paragraph 1 or 1A by an association of producers designated by the producers for the purpose of compliance with this Regulation.
1C.For the purposes of this Subsection, “the assessing competent authority” in relation to an application is the competent authority referred to in paragraph 1 or 1A respectively, except where a transfer has been agreed under Article 12A(1).
1D.An application under paragraph 1 or 1A must be submitted together with a summary and a complete dossier as provided for in Article 8(1) and (2) 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.]
F22.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
[F3The assessing competent authority] shall assess the confidentiality requests. Upon a request for access to information, the [F4assessing competent authority] shall decide what information is to be kept confidential.
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.
[F55.When assessing the application the assessing competent authority may obtain independent scientific advice, where the assessing competent authority considers it appropriate to do so.]
Textual Amendments
F1Art. 7(1)-(1D) substituted for Art. 7(1) (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(5)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 7(2) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(5)(b) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 7(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(5)(c)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 7(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(5)(c)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F5Art. 7(5) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(5)(d) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)