UK Offence Report

Offence and penalties

regulation 32(2) of The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

What the provision says

2 Any person who contravenes or fails to comply with any provision of regulation 19, 21 to 26 or 27(6) shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale.

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 This is the text as originally made; later amendments are not shown here.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
Legal burden on the defendant

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 gives a defence the defendant must prove, on the balance of probabilities. A legal burden of that kind can be read down to a merely evidential one under section 3 of the Human Rights Act 1998 where placing it on the defendant would be disproportionate (R v Lambert [2001] UKHL 37; Sheldrake v DPP [2004] UKHL 43).

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

The defence, as drafted

manufactured or assembled as not to comply with his order, it shall be a defence for him to prove— a that, in placing his order, a copy of the documents forming part of the Article 8 dossier relating to the manufacture and assembly of the product were available, or had been provided, to that other person and the person responsible for marketing the regist

What would breach regulation 32(2)?

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 or fails to comply with any provision of regulation 19, 21 to 26 or 27(6).
  2. Doing the thing the provision prohibits under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997, 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
Summary only — tried in a magistrates’ court
Maximum fine
£1,000
Standard scale
Level 3
Maximum prison (summary)
Not determined

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
Revoked
Revoked by
The Transfer of Functions (Medicines and Poisons) Order 1999
Revoked on
27 December 1999
Made
12 February 1997
In force from
31 March 1997
Extent
Not stated

How this was established: the instrument was revoked by a later instrument found in this corpus.

What the instrument is for

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

These Regulations, which come into force on 31st March 1997, implement the provisions of Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (OJ No. L297, 13.10.92, p. 12) insofar as they relate to homoeopathic veterinary medicinal products that satisfy all of the conditions specified in Article 7.1 of that Directive (“products”). The Regulations apply to products other than those that were marketed in the United Kingdom for the first time before 31st March 1997 (regulation 3). The principal provisions of the Regulations— a include provisions relating to applications for the registration of products to which the Regulations apply (“relevant products”) (regulation 4), the renewal of such registrations (regulation 7), the alteration of dossiers on which registrations are based (regulation 8) , the suspension and revocation of registrations (regulation 9) and the service of prohibition and withdrawal notices relating to registered products (regulation 10); b include provisions relating to applications for the grant of authorisations (“Article 24 authorisations”) authorising the manufacture of registered products and the import of such products from third countries (regulation 13) and the suspension and revocation of such authorisations (regulation 16); c prohibit the marketing of a relevant product on or after 1st September 1997 unless it is registered and complies with the dossier on which its registration is based (regulation 18); d lay down requirements relating to the labelling of registered products and their package inserts (regulation 21); e prohibit the manufacture of a relevant product, or the import of such a product from a third country, on or after 1st September 1997 unless the product is registered, an Article 24 authorisation has been obtained authorising its manufacture or import and its manufacture or import is in accordance with that authorisation (regulations 22 and 23); f lay down requirements relating to the export of specified registered products to other EEA States (regulation 24); g provide for the enforcement of the Regulations (regulation 31); h make the contravention, or failure to comply with, provisions of specified regulations a criminal offence (regulation 32); i apply specified provisions of the Medicines Act 1968 (c. 67) to relevant products (regulation 34); and j disapply certain provisions of the Trade Descriptions Act 1968 (c. 29) and Part II of the Consumer Protection Act 1987 (c. 43) in relation to registered products (regulation 35). A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3NB.

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