Regulation 37B Manufacturing and assembly of POC medicinal products: additional requirementsF1
In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) 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 POC sites specified in the POC master file;
only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and
a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC 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