UK Offence Report

Marketing of products not in accordance with a marketing authorisation

regulation 6 of The Veterinary Medicines Regulations 2013

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

6 The holder of

a marketing authorisation for

a veterinary medicinal product is guilty of an offence if either the holder or the manufacturer supplies

a product that is not completely in accordance with the marketing authorisation.

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 This is the text as originally made; later amendments are not shown here.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 holder
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 holder 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

In proceedings for an offence under these Regulation 43(g), 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 6?

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 2013 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)
6 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
6 August 2013
In force from
1 October 2013
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 2011 (S.I. 2011/2159). The major change to the Regulations is the adjustment of the fees with a view to achieving full cost recovery while avoiding cross-subsidy of one activity by another. In Great Britain food businesses will pay a much lower fee on application for approval but will pay a larger fee for any inspection. Premises will be selected for inspection on the basis of risk analysis. The fees for appeals to the Veterinary Products Committee are simplified. Criminal offences have also been amended. Instead of creating an individual offence in relation to every obligation there is now a single offence governing all relevant obligations in the body of the Regulations and a single offence in each of Schedules 1 to 5. Regulation 35 extends inspectors’ power of seizure to cover anything they reasonably believe to be, or which purports to be, a veterinary medicine. Veterinary practice premises must be registered with the Royal College of Veterinary Surgeons and paragraph 8 of Schedule 3 gives the Secretary of State a power to require the removal of premises from this register where they fail to meet the necessary standard. The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement the following EU instruments that are Directives: a Council Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, so far it is not superseded by Regulation (EC) No 183/2005; b Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products; and c Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. They provide for the enforcement of the following EU instruments that are Regulations besides that mentioned above: d Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ No L 31, 1.2.2002 p. 1), in so far as it applies to veterinary medicinal products used in feedingstuffs e Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (OJ No L 268, 18.10.2003 p. 29), in so far as it applies to veterinary medicinal products used in feedingstuffs; f Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ NO L 191, 28.5.2004, p.1), in so far as it applies to veterinary medicinal products used in feedingstuffs; g Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene (OJ No L 35, 8.2.2005, p. 1), in so far as it applies to veterinary medicinal products used in feedingstuffs; and h 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 (OJ No L152, 16.6.2009, p. 11). 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 they 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 the 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 an offence of importation, possession or supply of unauthorised veterinary medicinal products (regulation 43(q) to (s)). 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 36 and 38 to 42) and create offences of obstructing a person acting in the execution of these Regulations (regulation 43(u)) and of failing to comply with an improvement notice (regulation 43(v)). Under regulation 44 breach of the Regulations is an offence punishable— i on summary conviction, by a fine not exceeding the statutory maximum or by imprisonment for a term not exceeding three months or both, or j on conviction on indictment, by a fine or to imprisonment for a term not exceeding two years or both. Regulation 46 requires the Secretary of State to review the operation and effect of these Regulations, other than regulation 16 and Schedule 7 (which relate to fees), and lay a report before Parliament within five years after they come into force and within every five years after that. Following a review it will fall to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further instrument would be needed to revoke the Regulations or to amend them. Regulation 47 revokes the Veterinary Medicines Regulations 2011. 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.defra.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”. It is also published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

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