[F11.The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the competent authority.]
F22.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.Within 30 days of the [F3competent authority receiving] an application, [F4it] shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.
In the context of the validation referred to in the first subparagraph, the F5... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
The F6... competent authority shall, as soon as possible after [F7it has received] an application, inform the applicant of the fees payable F8... and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
4.Where the F9... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.
The F9... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.
The F9... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F10.... In such cases, part of the fees paid F11... shall be reimbursed.
5.On validating an application in accordance with paragraph 3 or 4, the F12... competent authority shall without delay inform the applicant F13... accordingly, indicating the date of the validation.
F146.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Art. 7(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(2); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 7(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(3); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 7(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Art. 7(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Art. 7(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Art. 7(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 7(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Art. 7(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(4)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F9Word in Art. 7(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Art. 7(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(5)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Art. 7(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(5)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F12Word in Art. 7(5) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 67(6)(a); 2020 c. 1, Sch. 5 para. 1(1)