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Regulation 45U Offences: breach of regulations and false informationF1

(1)

A person is guilty of an offence if the person imports, manufactures or distributes an active substance in breach of regulation 45M(1).

(2)

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

(a)

a registration form received by the licensing authority under regulation 45N(1);

(b)

a notification to the licensing authority under regulation 45N(2) or 45P(4);

(c)

an application for a variation under regulation 45T(2); or

(d)

response to a notice under regulation 45T(4).

(3)

A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45P(6) or 45T(4).

Annotations

Textual amendments

F1

Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16

Notes on Part 3

Textual amendments

F1

Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4