The Human Medicines Regulations 2012

Supplementary provisions and offences U.K.

334.—(1) An inspector entering any premises by virtue of regulation 325 or of a warrant under regulation 326 may be accompanied by such persons, and take such equipment, as the inspector thinks appropriate.

(2) Where an inspector enters premises in pursuance of a warrant under regulation 326, the inspector must, if the property is unoccupied or the occupier is temporarily absent, leave the premises as effectively secured against trespass as they were before the inspector entered.

(3) It is an offence for a person—

(a) intentionally to obstruct an inspector;

(b) intentionally to fail to comply with a requirement properly made under regulation 327 by an inspector; or

(c) without reasonable cause, to fail to give an inspector any other assistance or information which the inspector may reasonably require in order to perform a function under these Regulations.

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(5) A person who knowingly makes a false statement in giving information as mentioned in paragraph (3)(c) is guilty of an offence.

(6) A person who breaches the prohibition in regulation 332(1) (restrictions on disclosure of information) is guilty of an offence.

(7) A person who is guilty of an offence under paragraph (5) or (6) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.

(8) Nothing in this regulation is to be read as requiring a person to answer a question or to give information if doing so might incriminate that person or the spouse or civil partner of that person.

(9) In this regulation “occupier”, in relation to a ship, aircraft, or vehicle, is to be read in accordance with regulation 326(4).

Modifications etc. (not altering text)

C1 Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))