Regulation 207 Offences
(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.
Annotations
Textual amendments
- F1
Words in reg. 207(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 171; 2020 c. 1, Sch. 5 para. 1(1)