(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.