Regulation 17B Manufacturing of POC medicinal productsF1
A person may not manufacture or assemble a POC medicinal product unless—
(a)
it is specified in a manufacturer’s licence (POC); and
(b)
there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.
Annotations
Textual amendments
- F1
Regs. 17A, 17B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 6
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