PART 15 U.K.Amendments to Other Legislation

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 U.K.

61.—(1) The Medicines for Human Use (Clinical Trials) Regulations 2004 F1 are amended as follows.

(2) In regulations—

(a) 17(2)(b)(ii) (request for authorisation to conduct a clinical trial);

(b) 24(10) (amendments by the sponsor);

(c) 38(3)(b) (application for manufacturing authorisation); and

(d) 44(8) (variation of manufacturing authorisation)

for “Medicines (Products for Human Use) (Fees) Regulations 2013” substitute “ Medicines (Products for Human Use) (Fees) Regulations 2016 ”.

Textual Amendments

F1 S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.