Regulation 37A Manufacturing and assembly of MM medicinal products: additional requirementsF1
In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—
the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and
only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file.
Annotations
Textual amendments
- F1
Regs. 37A, 37B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 14
Notes on Part 3
Textual amendments
- F1
Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4
Notes on Chapter 2
Textual amendments
- F1
Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4