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Article 10 Joining or replacing participants by mutual agreement

United Kingdom

Original text. Later amendments are not shown.

1.

The role of participant may be taken over or shared by mutual agreement between an existing participant and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant.

2.

A notification for the purpose of this Article shall be submitted jointly to the F1competent authority by the prospective and the existing participant through F2the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 F3..., and shall include all relevant letters of access.

3.

Upon receipt of a notification complying with paragraph 2, the competent authority shall update F4its records with respect to the identity of the participant.

4.

A person established in the F5United Kingdom having taken over or joined the role of participant pursuant to this Article shall be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation (EU) No 528/2012.

Annotations

Textual amendments

F1

Words in Art. 10 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. 222(2); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in Art. 10(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. 222(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in Art. 10(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. 222(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F4

Words in Art. 10(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. 222(4); 2020 c. 1, Sch. 5 para. 1(1)

F5

Words in Art. 10(4) 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. 222(5); 2020 c. 1, Sch. 5 para. 1(1)