Regulation 44B Variation of POC (IMP) master fileF1
Subject to regulation 45(6), the holder of a manufacturing authorisation (POC) may amend the information in the POC (IMP) master file provided in accordance with paragraph 11(a), (b) and (g) to (i) of Schedule 6 and paragraph 14M(a) of Schedule 7 without applying to the licensing authority for a variation under regulation 44.
Annotations
Textual amendments
- F1
Regs. 44A, 44B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 46