Regulation 44A Variation of MM (IMP) master fileF1
Subject to regulation 45(5), the holder of a manufacturing authorisation (MM) may amend the information in the MM (IMP) master file provided in accordance with paragraph 10(a), (c) and (h) to (k) of Schedule 6 and paragraph 14E(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