UK Offence Report

Administration under an animal test certificate

paragraph 9(3) of SCHEDULE 4 of The Veterinary Medicines Regulations 2008

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

What the provision says

3 The holder of an animal test certificate who supplies

a product for administration that is not within the terms of the animal test certificate 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 This is the text as originally made; later amendments are not shown here.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 paragraph 9(3) of SCHEDULE 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. On these words an offence is committed where a person supplies a product for administration that is not within the terms of the animal test certificate.
  2. Selling the goods under the Veterinary Medicines Regulations 2008 where the instrument prohibits the sale outright.
  3. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  4. 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 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
Revoked
Revoked by
The Veterinary Medicines Regulations 2009 (revoked)
Revoked on
1 October 2009
Made
26 August 2008
In force from
1 October 2008
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 revoke and remake with amendments the Veterinary Medicines Regulations 2007. The new Regulations introduce a fee for the registration of veterinary premises for the supply of veterinary medicinal products. They provide comprehensive rights of appeal to an appointed person when applications for the authorisation or approval of manufacture or retail premises are refused. They introduce new controls on the collection and supply of equine stem cells. They introduce compulsory variations by the Secretary of State for manufacturers and wholesale dealers. They allow suitably qualified persons to supply veterinary medicines to retail customers from pharmacies or registered veterinary premises without dual registration. They introduce record-keeping requirements in relation to adverse reactions to products marketed under the small animals exemption scheme. They update fees. They have been changed so that the drafting is now gender-neutral. They make an amendment to the Medicines Act 1971 arising from veterinary medicinal products no longer being licensed under the Medicines Act 1968. 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 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 43 breach of the Regulations is an offence punishable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or b 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