PART 11Pharmacovigilance

Enforcement

Offences207

1

A person is guilty of an offence if the person commits a breach of a provision in this Part, other than F1Schedule 12A (further requirements in respect of pharmacovigilance activities) and regulation 199(2) or (6) (submission of draft study protocols for required studies).

2

A breach of a provision in this Part includes any—

a

failure by a holder to comply with any requirement or obligation in this Part; or

b

contravention by any person of any prohibition in this Part.