PART 15Amendments to Other Legislation

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 200461

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 ”.