Regulation 36A Manufacture of MM investigational medicinal productsF1

(1)

No person shall manufacture or assemble an MM investigational medicinal product unless—

(a)

the activity and product type is specified in a manufacturing authorisation (MM); and

(b)

there is an MM (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file.

(2)

Paragraph (1) does not apply to the manufacture or assembly of an MM investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product.

Annotations

Textual amendments

F1: Regs. 36A, 36B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 42