Regulation 256M Offences: breach of regulations and false informationF1

(1)

A person is guilty of an offence if the person—

(a)

contravenes regulation 256B(1); or

(b)

offers medicinal products for sale at a distance otherwise than in accordance with the conditions in regulation 256H.

(2)

A person is guilty of an offence if the person knowingly gives false information in—

(a)

an application to be entered on the list in accordance with regulation 256C(2);

(b)

an application for a variation in accordance with regulation 256L(2); or

(c)

response to a notice under regulation 256L(4).

(3)

A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 256F(3) or 256L(4).

(4)

A person is guilty of an offence if that person fails to inform the F2licensing authority—

(a)

of a falsified medicinal product in accordance with regulation 256F(1); or

(b)

about a material change of circumstances in accordance with regulation 256F(2).

(5)

It is a defence for a person charged with an offence under paragraph (4) to show that the person exercised all due diligence to avoid committing the offence.

Annotations

Textual amendments

F1: Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28
F2: Words in regs. 256C-256M substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 197(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 151); 2020 c. 1, Sch. 5 para. 1(1)