Article 5 Information requirements
United Kingdom
An application submitted in accordance with Article 50(2) of Regulation (EU) No 528/2012 shall contain the following:
- (1)
- (2)
a description of all the changes sought;
- (3)
where a change leads to or is the consequence of other changes of the terms of the same authorisation, a description of the relation between these changes;
- (4)
all relevant supporting documents to demonstrate that the proposed change would not adversely affect the conclusions previously reached concerning the compliance with the conditions set out in Article 19 or 25 of Regulation (EU) No 528/2012; F6, including any further information requested by the competent authority.
- (5)
F7...
Annotations
Textual amendments
- F1
Words in Art. 5(1) 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. 182(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Art. 5(1)(b)-(d) 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. 182(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Words in Art. 5(1)(e) 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. 182(2)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F4
Art. 5(1)(e)(1) 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. 182(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
- F5
Art. 5(1)(e)(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. 182(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
- F6
Words in Art. 5(4) inserted (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. 182(3); 2020 c. 1, Sch. 5 para. 1(1)
- F7
Art. 5(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. 182(4); 2020 c. 1, Sch. 5 para. 1(1)