Paragraph 14P F1
The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.
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