Paragraph 6

The holder of the authorisation shall—

(a)

F1except in the case of an MM investigational medicinal product or a POC investigational medicinal product, inform the licensing authority before making any material alteration in the premises or plant used under his authorisation, or in the operations for which they are used; and

(b)

inform the licensing authority of any change that he proposes to make in any personnel named in his authorisation as respectively—

(i)

responsible for supervising the production operations, or

(ii)

responsible for quality control of the investigational medicinal products being manufactured or assembled including the person named as the qualified person for the purposes of regulation 43 and paragraph 14.

Annotations

Textual amendments

F1: Words in Sch. 7 Pt. 2 para. 6(a) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 52(5)