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Paragraph 6A F1

The holder of the authorisation shall inform the licensing authority before making a material alteration to the premises or plant used at the MM (IMP) control site or to any modular unit specified in the MM (IMP) master file, or to the operations for which they are used.

Annotations

Textual amendments

F1

Sch. 7 Pt. 2 paras. 6A, 6B 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(6)