Paragraph 14E F1
An MM (IMP) master file shall contain, as a minimum, the following information:
(a)
the information specified in paragraph 10 of Schedule 6; and
(b)
the location of any modular units at which manufacturing or assembly of the MM investigational medicinal product has commenced, has been suspended or has ceased, and the date on which manufacturing or assembly commenced, the dates on which it is suspended, or the date from which it has ceased.
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)