Paragraph 14O F1
A POC master file must contain, as a minimum, the following information:
(a)
the information specified in paragraph 1B(2) of Schedule 3; and
(b)
the location of any POC sites at which manufacturing or assembly of the POC 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