Paragraph 14I F1
The holder of a manufacturing authorisation (MM) shall ensure that—
(a)
the requirements of paragraphs 1 to 14 and 14C to 14H are complied with in relation to manufacturing carried out at the modular units specified in the MM (IMP) master file;
(b)
only the MM investigational medicinal products specified in the MM (IMP) master file are manufactured or assembled at those modular units; and
(c)
an MM investigational medicinal product specified in the MM (IMP) master file is only manufactured on premises specified in the MM (IMP) master file.
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)