Paragraph 14C F1
The holder of the authorisation shall maintain and make available on request of the licensing authority an MM (IMP) master file for each MM investigational medicinal product to which the authorisation relates.
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)