Regulation 61 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

(1)

The Medicines for Human Use (Clinical Trials) Regulations 2004 M1 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 ”.

Annotations

M1: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.