Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

paragraph 7(1) of SCHEDULE 5 of The Veterinary Medicines Regulations 2011 (revoked)

Status not determined
Strict liability
Drugs and medicines

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

1 It is an offence to incorporate
a veterinary medicinal product into
a premixture or feedingstuffs, or to act as
a distributor of premixtures or feedingstuffs containing
a veterinary medicinal product, without being approved to do so by the Secretary of State.

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 This is the text as originally made; later amendments are not shown here.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

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 7(1) of SCHEDULE 5?

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.

Doing what the provision prohibits, or failing to do what it requires under the Veterinary Medicines Regulations 2011.

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.

Drug offences: definitive guideline Magistrates' courts and the Crown Court in England and Wales
Covers importation, supply, production and possession of controlled drugs, with sentencing driven by drug class and the offender's role.
Reduction in sentence for a guilty plea: definitive guideline All courts in England and Wales · in force from 1 June 2017
The sliding scale of credit for pleading guilty, from one third at the first stage of proceedings downwards.
General guideline: overarching principles All courts in England and Wales · in force from 1 October 2019
The guideline a court uses when there is no offence-specific guideline, which is the position for the overwhelming majority of offences created by statutory instrument. It sets out how culpability and harm are assessed from first principles.
Totality: definitive guideline All courts in England and Wales
How to sentence more than one offence at once so that the total is just and proportionate - frequently in point here, because regulatory prosecutions commonly charge several breaches of the same instrument.

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: 25 August 2011
In force from: 1 October 2011
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

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009. Implementation of European obligations These Regulations introduce a new fee-structure for variations to national procedures necessary as a result of the adoption of Commission Regulation (EC) 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. They implement Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. They also provide for the enforcement of Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed in relation to feedingstuffs containing specified feed additives, and also for the enforcement of Articles 15 and 17 of that Regulation as they refer to the labelling requirements for feedingstuffs containing specified feed additives (regulation 14 and Schedule 5). Other changes Otherwise the principal changes made are as follows. They introduce procedures and a fee for giving formal advice as to whether a product requires a marketing authorisation (regulation 16 and paragraph 53 of Schedule 7). They introduce a procedure and fee to change the distribution category for products authorised through the centralised procedure (regulation 16 and paragraph 16 of Schedule 7). They introduce a waiver for fees for variations to remove or reduce animal testing (regulation 16 and paragraph 21 of Schedule 7). They introduce a below-inflation fee increase for some inspection fees (regulation 16 and Schedule 7). The Regulations 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: Council Directive 90/167 laying down 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; Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products; and 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 those mentioned above: 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, in so far as it applies to veterinary medicinal products used in feedingstuffs; Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, in so far as it applies to veterinary medicinal products used in feedingstuffs; 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, in so far as it applies to veterinary medicinal products used in feedingstuffs; Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene, in so far as it applies to veterinary medicinal products used in feedingstuffs; and 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. 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 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 36 and 38 to 42) and create offences of obstructing a person acting in the execution of these Regulations (regulation 37) and of failing to comply with an improvement notice (regulation 38). Under regulation 43 breach of the Regulations is an offence punishable— on summary conviction, by a fine not exceeding the statutory maximum or by imprisonment for a term not exceeding three months or both, or on conviction on indictment, by a fine or to imprisonment for a term not exceeding two years or both. Regulation 45 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 46 contains revocations. 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”.

Read the full note and every offence in this instrument

Other offences in the same instrument

Supply of a veterinary medicinal product for incorporation into feedingstuffsparagraph 11(5) of SCHEDULE 3
Labelling at the time of retail supplyparagraph 12(1) of SCHEDULE 3
Labelling at the time of retail supplyparagraph 12(3) of SCHEDULE 3
Labelling a premixture containing a veterinary medicinal productparagraph 12(4) of SCHEDULE 5
Labelling of feedingstuffs containing a specified feed additiveparagraph 13 of SCHEDULE 5
Authorisation to manufacture autogenous vaccinesparagraph 14(4) of SCHEDULE 2
Supply by a suitably qualified personparagraph 14(4) of SCHEDULE 3
Labelling of feedingstuffs containing a veterinary medicinal productparagraph 14(4) of SCHEDULE 5
Supply by a suitably qualified personparagraph 14(6) of SCHEDULE 3
Supply of specified feed additivesparagraph 15(1) of SCHEDULE 5
Supply of specified feed additivesparagraph 15(4) of SCHEDULE 5
Supply of premixtureparagraph 16(1) of SCHEDULE 5

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 0.90.

Basis: the provision says “it is an offence”; the provision says an offence is committed “if” something happens
Confidence: 0.90 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

This provision on legislation.gov.uk The authoritative text. Check it before relying on anything here.
The Veterinary Medicines Regulations 2011 (revoked) Every offence this instrument creates, and its explanatory note
Drugs and medicinesOther offences on the same subject
Offences created in 2011