UK Offence Report

Application of the Act to radiopharmaceutical-associated products

regulation 2(3) of The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992

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

3 For the purposes of Part I, sections 108 to 115, 118, 119 and 125 of, and Schedule

3 to, the Act—

a the provisions of the Act applied by paragraphs (1) and (2) of this regulation to radiopharmaceutical-asociated products, and the provisions of any regulations made under any of those provisions as so applied, shall be treated as provisions of, respectively, the Act and regulations made under it;

b any offence against any of those provisions shall be treated as an offence under the Act; and

c any reference in any of those provisions to medicinal products shall be treated as including

a reference to radiopharmaceutical-associated products.

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 This is the text as originally made; later amendments are not shown here.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
breaching the provision
Fault element
Strict liability
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

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

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 2(3)?

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. Doing what the provision prohibits, or failing to do what it requires under the Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992.

Penalty

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

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

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
9 March 1992
In force from
11 March 1992
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 apply, with necessary modifications, certain provisions of the Medicines Act 1968 (notably those relating to product licences) to radiopharmaceutical kits, generators and precursors, thereby implementing in part Council Directive 89/343/EEC relating to radiopharmaceuticals (OJ No. L142 25.5.1989 p. 16) (regulation 2 and the Schedule). They include transitional protection until 31st December 1992 for products on the market in the United Kingdom immediately before 3rd April 1992 (regulation 3).

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 0.60.

Basis
c11_treated_as_offence
Confidence
0.60 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