PART 2

Human medicines
CHAPTER 1

Regulations: general

Fees, offences, powers of inspectors
6
1
Regulations under section 2(1) may make provision—
a
about the charging of fees in connection with the exercise of a function conferred by a human medicines provision,
b
creating a criminal offence of failing to comply with a provision made in the regulations, or
c
applying relevant powers of entry or other powers of inspectors with or without modification in relation to a prohibition or requirement in provision made in the regulations.
2
Regulations under section 2(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.
3
In subsection (1), “relevant powers of entry or other powers of inspectors” means powers of entry or powers of inspectors in—
a
Part 8 of the Medicines Act 1968;
b
the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);
c
Part 16 of the Human Medicines Regulations 2012 (S.I. 2012/1916).
4
In this Part, “human medicines provision” means a provision in—
a
regulations under section 2(1),
b
the Human Medicines Regulations 2012, or
c
the Medicines for Human Use (Clinical Trials) Regulations 2004.
S. 6(4) in force at 11.2.2021 see s. 50(1)(c)
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)