Paragraph 14P 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 POC (IMP) site 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)