UK Offence Report

Amendment to regulation 49

regulation 34(4) of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

9 Any person who sells or supplies, or procures the sale or supply of, a non-investigational medicinal product— a to a participant for the purposes of a clinical trial; or b to a person for the purpose of administering the product to such a participant, the labelling of which does not comply with regulation 46A, knowing, or having reasonable cause to believe, that the labelling does not so comply, shall be guilty of an offence. .

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a person
Conduct
selling or supplying something the instrument restricts
Fault element
Objective fault
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened and that it fell below the standard the provision sets. That is an objective test - what a reasonable person in the same position would have done, not what this defendant actually thought.

What a person personally believed or intended is not the question; the standard is what was reasonable.

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: objective standard in the offence-creating words: reasonable cause to believe.

What would breach regulation 34(4)?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. Selling the goods under the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 where the instrument prohibits the sale outright.
  2. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  3. Offering for sale counts as well as selling: displaying stock is enough where the provision reaches an offer.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated here: this instrument amends another one, and the penalty for the offence is in the instrument being amended.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Status not determined
Made
28 April 2025
In force from
Not determined
Extent
Not stated

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 Regulations”) which implement Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products in humans. Following withdrawal of the UK from the European Union, these Regulations are made in exercise of the powers conferred by sections 2(1), 5(1)(a) to (e), 6(1)(b) and 43 of the Medicines and Medical Devices Act 2021, in respect of clinical trials in the United Kingdom. These Regulations make provision for the following matters: a Part 3 amends the provisions on the operation and constitution of the ethics committee, which are contained in Part 2 of the 2004 Regulations. b Part 4, which amends Part 3 of the 2004 Regulations, revises the approval procedure for clinical trials, combining the separate applications for regulatory authorisation and ethics committee opinion into one application route, leading to a co-ordinated review and a single UK decision. For trials considered lower risk, this will be notified and can be given automatic regulatory authorisation. The combined procedure is extended to substantial amendments to the trial approval, and references to amendments are replaced with references to modifications. This Part also introduces transparency requirements, which are to require registration of the trial in a public register, to publish a summary of the trial results, and to share those results with the participants. c Part 5 amends the provisions on the principles and conditions of good clinical practice by reference to the ICH guideline and makes clear, in applying those principles and conditions that the functions of the sponsor include those in relation to the development and maintenance of trial specific computerised systems. d Part 6 makes a number of changes to Part 5 of the 2004 Regulations, which concerns the pharmacovigilance requirements that apply to clinical trials under Part 5, in particular to allow aggregate reporting, and to impose specific requirements with respect to record keeping and the content of the annual report on the safety of trials. e Part 7 amends Part 6 of the 2004 Regulations on manufacturing and importation, and provides for an exemption from the need, in certain circumstances, for a manufacturing authorisation in respect of radiopharmaceuticals used for diagnostic purposes. f Part 8, which inserts a new Part 6A to the 2004 Regulations, makes a new provision concerning medicinal products which are used in the trial, but which are not being tested. g Part 9, which amends Part 7 of the 2004 Regulations, makes similar provision to the EU Clinical Trials Regulation in respect of labelling of investigational and non-investigational medicinal products. h Part 10 makes consequential changes to Part 8 of the 2004 Regulations relating to enforcement of the Regulations and extends the power of the licensing authority to issue infringement notices to facilitate compliance with the Regulations. i Part 11 amends all the Schedules that are related to the changes made to Parts 2 to 4 of the 2004 Regulations. j Part 12 inserts a new Schedule 14, which makes transitional provisions in relation to existing authorisations and applications. References throughout the Regulations to a clinical trial subject are replaced with references to a participant; and similarly, references to a trial site, are replaced with references to a trial location. A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. A de minimis assessment is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU and is published with the explanatory memorandum alongside this instrument at www.legislation.gov.uk.

Read the full note and every offence in this instrument

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis
the provision says a person is “guilty of an offence”
Confidence
0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source