CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

Submission and validation of applications
Article 7
1
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.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Within 30 days of the competent authority receiving an application, it 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 ... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
The ... competent authority shall, as soon as possible after it has received an application, inform the applicant of the fees payable ... 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 ... 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 ... 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 ... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant .... In such cases, part of the fees paid ... shall be reimbursed.
5
On validating an application in accordance with paragraph 3 or 4, the ... competent authority shall without delay inform the applicant ... accordingly, indicating the date of the validation.
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 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)
Art. 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)
Words 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)
Word 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)
Word 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)
Word 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)
Words 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)
Words 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)
Word 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)
Words 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)
Words 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)
Word 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)
Words 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)(b); 2020 c. 1, Sch. 5 para. 1(1)
Art. 7(6) 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(7); 2020 c. 1, Sch. 5 para. 1(1)