Paragraph 1
The holder of the authorisation shall—
provide and maintain such staff, premises and plant (including technical equipment) as are necessary for the carrying out of such stages of the manufacture and assembly of the investigational medicinal products or EAMs medicinal products as are undertaken by the holder, in accordance with the following—
the holder’s authorisation;
the product specification;
the MM (IMP) master file, in the case of an MM investigational medicinal product; and
the POC (IMP) master file, in the case of a POC investigational medicinal product;
F2except in the case of an MM investigational medicinal product and a POC investigational medicinal product, not carry out any such manufacture or assembly except at the premises specified in his manufacturing authorisation.
Annotations
Textual amendments
- F1
Sch. 7 Pt. 2 para. 1(a) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 52(2)(a)
- F2
Words in Sch. 7 Pt. 2 para. 1(b) 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(2)(b)