Paragraph 14Q F1
The holder of a manufacturing authorisation (POC) shall ensure that—
(a)
the requirements of paragraphs 1 to 14 and 14K to 14P are complied with in relation to manufacturing carried out at the POC (IMP) sites specified in the POC (IMP) master file;
(b)
only the POC investigational medicinal products specified in the authorisation are manufactured or assembled at those sites; and
(c)
a POC investigational medicinal product specified in the authorisation is only manufactured at a POC (IMP) site specified in the POC (IMP) master file.
Annotations
Textual amendments
- F1
Sch. 7 Pts. 2A, 2B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 52(7)