SCHEDULES
C1SCHEDULE 31Sampling
Introductory
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—
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.
Sch. 31 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))