OpenLegislation

Paragraph 3

The holder of the authorisation shall place the quality control system referred to in Article 11(1) of Commission Directive 2003/94/EC F1in respect of Great Britain, or Article 10(1) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland, under the authority of the person notified to the licensing authority in accordance with paragraph 6(3) of Schedule 6 as being responsible for quality control.

Annotations

Textual amendments

F1

Words in Sch. 7 Pt. 2 para. 3 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 42(3)(a)