The Human Medicines Regulations 2012

IntroductoryU.K.

1.—(1) This Schedule has effect where a person authorised by an enforcement authority (in this Schedule referred to as a “sampling officer”) obtains a sample of a substance or article—U.K.

(a)in order to determine whether there has been a contravention of any provision of these Regulations which the enforcement authority (“the relevant enforcement authority”) must or may enforce by virtue of regulations 323 and 324; or

(b)otherwise for a purpose connected with the performance of the relevant enforcement authority of its functions under these Regulations.

(2) This Schedule has effect whether the sample is obtained by purchase or in exercise of a power conferred by regulation 327.

(3) In this Schedule “medicines control laboratory” means a laboratory that is—

(a)designated by the licensing authority in accordance with Article 111(1) of the 2001 Directive for the purpose of the analysis of samples of one or more types of medicinal product; and

(b)is so designated in relation to a particular medicinal product that is submitted to it for analysis.