Article 50 Amendment of an authorisation at the request of the authorisation holder

United Kingdom

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An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent F2authority. F3The competent authority shall decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.

The application shall be accompanied by the F4appropriate fees.

An amendment to an existing authorisation shall fall under one of the following categories of changes:

(a)

administrative change;

(b)

minor change; or

(c)

major change.

Annotations

Textual amendments

F1: Art. 50(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. 97(2); 2020 c. 1, Sch. 5 para. 1(1)
F2: Word in Art. 50(2) 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. 97(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in Art. 50(2) 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. 97(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in Art. 50(2) 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. 97(3)(c); 2020 c. 1, Sch. 5 para. 1(1)