Article 13 Submission and acceptance of applications
United Kingdom
Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the F1competent 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.
When applying for the renewal of the approval of the active substance, the applicant shall submit:
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
its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.
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Annotations
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)