UK Offence Report

Classification, supply and possession of the product

regulation 7(4) of The Veterinary Medicines Regulations 2009 (revoked)

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

4 Any person who supplies an authorised human medicinal product for administration to an animal (other than

a product supplied by

a veterinary surgeon or in accordance with

a written prescription from

a veterinary surgeon that includes all the information specified in paragraph

6 of Schedule 3) is 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 This is the text as originally made; later amendments are not shown here.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
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

an offence under these Regulations relating to advertising, it is a defence for the person charged to prove— a that that person’s business is to publish or arrange for the publication of advertisements, and b that the advertisement was received in the ordinary course of business and the person charged did not know and had no reason to suspect that its publication w

What would breach regulation 7(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 Veterinary Medicines Regulations 2009 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
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
3 months
Maximum prison (on indictment)
2 years

expressed as the statutory maximum (the prescribed sum): the same words mean £5,000 in England and Wales and £10,000 in Scotland.

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
12 August 2009
In force from
1 October 2009
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 revoke and remake with amendments the Veterinary Medicines Regulations 2008. These Regulations implement— a Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products; b Commission Directive 2009/9/EC amending Directive 2001/82 of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use. c Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin in so far as it amends Directive 2001/82. They replace references to Council Regulation (EC) No 2377/90 on establishing maximum residue limits for pharmacologically active substances with Regulation (EC) 470/2009 of the European Parliament and of the Council (Regulation (EC) No 470/2009 repeals and replaces Council Regulation (EC) No 2377/90 but the Annexes to Regulation 2377/90 are preserved pending the adoption of a Commission Regulation replacing them). For horse passports, they now refer to Commission Regulation (EC) No 504/2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for identification of equidae. Otherwise the principal changes are as follows. They remove the requirement to publicise a seizure notice in the case of a common carrier who does not own the seized goods (regulation 42). They create a new type of authorisation (a limited marketing authorisation) (paragraph 26 of Schedule 1). They create an offence of altering a written prescription without authorisation (paragraph 5 of Schedule 3). They introduce inflation-only fee increases to all application fees. They introduce a new fee structure for variations to European Marketing Authorisations from 1 January 2010, necessary as a result of the adoption of Commission Regulation 1234/2008, and remove the fees for on line applications for special import certificates, repeat special treatment certificates and Research Import Certificates (Schedule 7). The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement Directive 2001/82/EC. They enforce Regulations (EC) No 178/2002, No 1831/2003, No 882/2004, No 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs. They implement Council Directive 90/167 so far it is not superseded by Regulation (EC) No 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the rules of the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13 and Schedule 3). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 30). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 42). Under regulation 43 breach of the Regulations is an offence punishable— d on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or e on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. A full impact assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.

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