UK Offence Report

12 Any person who contravenes these regulations or who contravenes the provisions of section 85(3) or…

regulation 12 of The Medicines (Labelling and Advertising to the Public) Regulations 1978

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

12 Any person who contravenes these regulations or who contravenes the provisions of section 85(3) or section 86(2) of the Act shall be guilty of an offence and—

a shall be liable on summary conviction to

a fine not exceeding £400, and

b shall be liable on conviction on indictment to

a fine or to imprisonment for

a term not exceeding

2 years or to both.

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 This is the text as originally made; later amendments are not shown here.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
contravening a requirement of the instrument
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 12?

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. On these words an offence is committed where a person contravenes these regulations or who contravenes the provisions of section 85(3) or section 86(2) of the Act.
  2. Doing the thing the provision prohibits under the Medicines (Labelling and Advertising to the Public) Regulations 1978, whatever the reason for doing it.
  3. Where the requirement is a positive duty, letting the time for performing it pass without performing it.

Penalty

Mode of trial
Either way — magistrates’ court or Crown Court
Maximum fine
£400
Maximum prison (summary)
Not determined
Maximum prison (on indictment)
2 years

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
16 January 1978
In force from
1 February 1978
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 made under the Medicines Act 1968 impose requirements relating to the prohibition, restrictions and requirements for advertisements directed to the public relating to medicinal products and other substances and articles for administration to human beings. They prohibit the advertisement of medicinal products which are available on prescription only and certain representations made by commercially interested parties. They contain provisions dealing specifically with the contents and form of advertisements for, and the containers and packages of, spermicidal contraceptives and leaflets supplied with such products. The Regulations contain provisions prescribing exceptions to the requirements set out therein. They also contain transitional provisions and penalties for criminal offences in relation to both the regulations and related provisions in the 1968 Act. Amendments to the Medicines (Labelling) Regulations 1976 are also included which have the effect of altering the dates upon which whole-salers and retailers must comply with those regulations.

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”; the provision states liability on summary conviction; the provision states a penalty in older drafting
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