Regulation 28
Offences
of Medicines (Clinical Trials) Regulations 2016
Subregulation 1
A person shall be guilty of an offence if the person —
contravenes regulation 4(4) or (6), 5(1), (2), (3), (4) or (6), 6, 7, 8(1), 10(1), (2) or (4), 11(1), (2) or (3), 12(1), (2), (3) or (4), 13(1) or (2), 14, 15, 16(1), (9) or (10), 17(3), (4), (5) or (7), 18(1) or (6), 19(3), 20, 22(2), 23(1) or (3), 24(1), (2) or (4), 25(1), (2), (3) or (4), 26(1), (2), (3) or (4) or 27(1); or
for the purpose of making any application or in giving any notification, record or report to the Authority under these Regulations, furnishes the Authority with any particulars, information or document which the person knows is false or misleading, or any sample which the person knows is altered or adulterated.
Subregulation 2
A person who is guilty of an offence under paragraph (1) shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 2 years or to both.