The Human Medicines Regulations 2012

Application of sampling procedure to substance or article seized under this Part U.K.

329.—(1) This regulation applies where an inspector seizes a substance or article under regulation 327 (powers of inspection, sampling and seizure).

(2) On request in accordance with paragraph (3), the inspector must either—

(a) set aside a sample of the substance or article seized; or

(b) treat the substance or article as a sample,

whichever seems more appropriate having regard to the nature of the substance or article.

(3) A request is made in accordance with this paragraph if—

(a) it is made by a person (“P”) who is entitled to be informed of the seizure under regulation 328; and

(b) it is made either at the time of the seizure or within the period of 21 days beginning with the day immediately after the day on which P is informed of the seizure.

(4) An inspector is not required by paragraph (2) to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.

(5) An inspector must—

(a) divide a sample under paragraph (2) into three parts;

(b) mark each part;

(c) seal or fasten each part; and

(d) supply one part to P.

(6) Paragraphs 10 to 12 and 15 to 26 of Schedule 31 apply to a sample under this regulation as they apply to a sample obtained as mentioned in paragraph 1 of that Schedule, but as if—

(a) references to the preceding provisions of that Schedule were references to the preceding provisions of this regulation;

(b) references to a sampling officer were references to an inspector who seized a substance or article under regulation 327 (powers of inspection, sampling and seizure); and

(c) a reference to the relevant enforcement authority were a reference to the authority by which the inspector is authorised.

Modifications etc. (not altering text)

C1 Regs. 325-330 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))