Medicines and Medical Devices Act 2021

6 Fees, offences, powers of inspectors

(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.