UK Offence Report

Offences and penalties

regulation 16(1) of The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

What the provision says

1 Any person contravening any provision of regulation 3, 6, 7, 8, or

14 of these Regulations shall be guilty of an offence and liable—

a on summary conviction, to

a fine not exceeding the statutory maximum; or

b on conviction on indictment, to

a fine or to imprisonment for

a term not exceeding two 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 This is the text as originally made; later amendments are not shown here.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
breaching the provision
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

as not to comply with the provisions of that authorisation, it shall be a defence for him to prove— a that he had communicated the provisions relating to the authorisation to that other person, and b that he did not know, and could not by the exercise of reasonable care have known, that those provisions had not been complied with.

What would breach regulation 16(1)?

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. Doing what the provision prohibits, or failing to do what it requires under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994.

Penalty

Mode of trial
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
Not determined
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
Revoked
Revoked by
The Marketing Authorisations for Veterinary Medicinal Products (Revocation of Confidentiality Provision) Regulations 2004 (revoked)
Revoked on
1 January 2005
Made
5 December 1994
In force from
1 January 1995
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 implement Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorisations rather than the previous system of product licences. These authorisations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (regulation 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorisation (regulations 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (regulation 6), on person where a product is manufactured outside the EEA (regulation 7) and on an importer who holds a marketing authorisation (regulation 8). There are provisions for the variation, renewal, suspension and refusal of an authorisation (regulations 9 to 13 and Schedule 3), provisions as to confidentiality (regulation 14) and fees (regulation 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17. Provisions of the Medicines Act 1968, under which the system was previously enforced, and provisions of the Trade Descriptions Act 1968 and the Consumer Protection Act 1987, are applied to marketing authorisations in the same way as they previously applied to product licences (regulation 19). Regulation 20 contains transitional provisions. Schedule 4 revokes the Medicines (Leaflets for Veterinary Drugs) Regulations 1983, S.I. 1983/1727, the Medicines (Veterinary Medicinal Products) (Applications for Product Licences Regulations) 1993, S.I. 1993/2398 and the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994, S.I. 1994/2157. Schedule 5 makes amendments to statutory instruments consequential on changing from product licences to marketing authorisations. A Compliance Cost Assessment has been prepared and placed in the library of each House of Parliament.

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.

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