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Paragraph 14H F1

The holder of the authorisation shall conduct regular reviews of the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and ensure that, where appropriate, remedial action is taken as soon as reasonably practicable.

Annotations

Textual amendments

F1

Sch. 7 Pts. 2A, 2B 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(7)