The Human Medicines Regulations 2012

[F1Offences: breach of regulations and false informationU.K.

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45K.—(1) A person is guilty of an offence if the person—

(a)contravenes regulation 45A(1); or

(b)brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.

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

(a)an application for a broker registration under regulation 45B(2);

(b)a notification to the licensing authority under regulation 45F(4);

(c)an application for a variation under regulation 45J(1); or

(d)response to a notice under regulation 45C(3) or 45J(5).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).]

Textual Amendments