Regulation 48 Infringement notices
United Kingdom
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”)—
informing him of the authority’s grounds for considering that the person has contravened one or more of those provisions;
specifying the relevant provision of these Regulations;
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;
requiring the person to take those measures, within such period as may be specified in the notice;
warning the person that unless the requirements of sub-paragraph (d) are met, further action may be taken in respect of the contravention.
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.
This regulation applies to regulations 3A, 12(1) and (2), 13(1), 22(2) to (5), 25(1) and (2)(a), 27, 28(1) to (3), 29, 29A, 30(2), 31A to 35, 36(1), 36A, 36B, 42, 43(1) and (6), 45A, 46 and 46A.
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 F4regulation 323(1) or 324(1) of the 2012 Regulations as applied by regulation 47.
Annotations
Textual amendments
- F1
Reg. 48(3)(a) omitted (31.12.2020) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Reg. 48(3)(c) and word omitted (31.12.2020) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 21(b); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Reg. 48(4) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 33
- 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)