PART 2

Human medicines
CHAPTER 1

Regulations: general

Clinical trials
5
1
Regulations under section 2(1) may make provision—
a
corresponding or similar to provision in the EU Clinical Trials Regulation,
b
about authorisations concerning clinical trials in the United Kingdom, including applications for an assessment of the ethics of a proposed clinical trial,
c
about notification and reporting requirements in relation to clinical trials,
d
about requirements that must be met before a clinical trial may be carried out, or
e
relating to the conduct of clinical trials.
2
In subsection (1)(a), “EU Clinical Trials Regulation” means Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
Pt. 2 Ch. 1 heading substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 101(2), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)