Paragraph 14F F1
An MM master file must contain, as a minimum, the following information—
(a)
the information specified in paragraph 1A(2) of Schedule 3; and
(b)
the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.
Annotations
Textual amendments
- F1
Sch. 4 Pts. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 35