The Medicines for Human Use (Clinical Trials) Regulations 2004

Infringement notices U.K.

48.—(1) If an enforcement authority have objective grounds for considering that any person has contravened any provision to which this regulation applies, they may serve upon that person a notice in writing (in these Regulations referred to as an “ infringement notice”)—

(a) informing him of the authority’s grounds for considering that the person has contravened one or more of those provisions;

(b) specifying the relevant provision of these Regulations;

(c) specifying the measures which the person must take in order to ensure that the contravention does not continue or, as the case may be, does not recur;

(d) requiring the person to take those measures, within such period as may be specified in the notice;

(e) warning the person that unless the requirements of sub-paragraph (d) are met, further action may be taken in respect of the contravention.

(2) An infringement notice may include directions as to the measures to be taken by the person on whom the notice is served to ensure that the contravention does not continue or, as the case may be, does not recur, including the different ways of securing compliance.

(3) If an enforcement authority serves an infringement notice in accordance with paragraph (1), they shall forthwith inform—

(a) the competent authorities of each EEA State, other than the United Kingdom;

(b) the relevant ethics committee; and

(c) the European Commission.

(4) This regulation applies to regulations [F1 3A, 12(1),] 22(b), 27, 28(1) to (3), 29, [F2 29A,] 30(2)[F3 , 31A] and 32 to 35.

(5) In this regulation, “enforcement authority” means any Minister or body on whom a duty or power to enforce any provisions of these Regulations is imposed or conferred by or under [F4 regulation 323(1) or 324(1) of the 2012 Regulations] as applied by regulation 47.

Textual Amendments

F1 Words in reg. 48(4) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 25(a)

F2 Word in reg. 48(4) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 25(b)

F3 Word in reg. 48(4) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 25(c)

F4 Words in reg. 48(5) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 58 (with Sch. 32)