The Medicines for Human Use (Clinical Trials) Regulations 2004

Application and effect of manufacturing authorisation U.K.

41.  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) the premises,

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

Textual Amendments

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)