Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 13 U.K. Submission and acceptance of applications

1. Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the [F1 competent authority] at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.

2. When applying for the renewal of the approval of the active substance, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.

F2 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 13(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. 74(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 13(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. 74(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 13(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. 74(c); 2020 c. 1, Sch. 5 para. 1(1)