PART 3F1Manufacture and distribution of medicinal products and active substances

Annotations:
Amendments (Textual)
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

F2CHAPTER 4Importation, manufacture and distribution of active substances

Annotations:
Amendments (Textual)

Offences: breach of regulations and false information45U

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).