Regulation 41 Application and effect of manufacturing authorisation

United Kingdom

A manufacturing authorisation shall apply only in relation to—

(a)

the descriptions of investigational medicinal products;

(b)

the manufacturing, assembling or importation operations; F1...

F2(bb)

in the case of an authorisation relating to the inactivation of viral or non-conventional agents, the manufacturing process; and

(c)

F3except in the case of an MM investigational medicinal product or a POC investigational medicinal product, the premises,

specified in the application made pursuant to regulation 38 and in respect of which the authorisation is granted.

Annotations

F1: Word in reg. 41(b) omitted (29.8.2006) by virtue of The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 21(a)
F2: Reg. 41(bb) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 21(b)
F3: Words in reg. 41(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 44