The Human Medicines Regulations 2012

Prosecutions U.K.

339.—(1) A magistrates' court in England or Wales may try an information for an offence under these Regulations that is triable only summarily if the information was laid at any time within the period of twelve months beginning with the commission of the offence.

(2) Summary proceedings in Scotland for an offence triable only summarily under these Regulations may be commenced at any time within the period of twelve months beginning with the commission of the offence (and section 136(3) of the Criminal Procedure (Scotland) Act 1995 M1 applies for the purposes of this paragraph as it applies for the purposes of that section).

(3) A magistrates' court in Northern Ireland may hear and determine a complaint for an offence punishable on summary conviction under these Regulations, other than an offence which is also triable on indictment, if the complaint was made at any time within the period of twelve months beginning with the commission of the offence.

(4) A body referred to in regulation 323(2) (enforcement in England, Wales and Scotland) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under that regulation unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Secretary of State.

(5) A district council (as defined in regulation 324 (enforcement in Northern Ireland)) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under regulation 324(2) unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Minister for Health, Social Services and Public Safety.

(6) A certificate of the Secretary of State or of the Minister for Health, Social Services and Public Safety that the requirements of paragraph (4) or, as the case may be, (5) have been complied with is to be conclusive evidence that the requirements have been complied with, and a document purporting to be such a certificate is to be presumed to be such a certificate unless the contrary is proved.

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))

Marginal Citations

M1 1995 c. 46.