UK Offence Report

Contravention of The Medicines (Veterinary Medicinal Products) (Applications for Product Licences)…

the instrument as a whole of The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993

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

Contravening this instrument is an offence under section

67 of the Medicines Act 1968. The instrument itself contains no offence-creating words.

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 This is the text as originally made; later amendments are not shown here.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

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.

Classifier’s reasoning: contravention offences of this kind are strict as to the breach; the fault position is governed by the parent Act and was not read from it.

What would breach the instrument as a whole?

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 Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993.

Penalty

Mode of trial
Set by another provision — the instrument states the penalty by reference to an Act or to another regulation
Maximum fine
Not determined
Maximum prison (summary)
Not determined

The instrument does not state a penalty itself. It sets one by reference to section 67 of the Medicines Act 1968.

the penalty is in the parent Act, not in this instrument.

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
Status not determined
Made
30 September 1993
In force from
29 October 1993
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 implement Articles 5 and 5a of Council Directive 81/851EEC (OJ No. L317, 6.11.81, p.1) (“Directive 81/851”) as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p.15) on the approximation of the laws of the Member States relating to veterinary medicinal products, Council Directive 81/852/EEC (OJ No. L317, 6.11.81, p.16) (“Directive 81/852”) as amended by Council Directive 87/20/EEC (OJ No. L15, 17.1.87, p.34) and Commission Directive 92/18/EEC (OJ No. L97, 10.4.92, p.1) on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, and Article 2 of Council Directive 90/677/EEC (OJ No. L373, 31.12.90, p.26) (“Directive 90/677”) extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products. The Regulations apply to applications for product licences in relation to veterinary medicinal products to which Directive 81/851 applies (see Article 2 of the Directive). Such products are to be treated as medicinal products within the meaning of section 130 of the Medicines Act 1968 for the purposes of the Regulations (see the definitions of “product licence” and “veterinary medicinal product” in regulation 2(1)). The Regulations prescribe the form and manner of an application (regulation 3), require the applicant to submit to the licensing authority the particulars and documents set out in Articles 5 and 5a of Directive 81/851, to comply with the provisions of Article 2 of Directive 90/677 in relation to immunological products and to comply with the requirements set out in the Annex to Directive 81/852 (regulation 4 and Schedules 1 and 2, which apply to veterinary medicinal products other than immunological products and veterinary medicinal products which are immunological products respectively). An applicant is required to confirm to the licensing authority that he has taken account of certain guidance published by the European Commission referred to in the Introduction to the Annex to Directive 81/852 (regulation 5(1)(a)). This guidance is at present contained in a publication entitled “The Rules Governing Medicinal Products in the European Community”, Volume V/B, “Notice to applicants for marketing authorisation for veterinary medicinal products in the European Community”, Revised Edition, January 1993 (ISBN 92-826-5780-9), which may be obtained from Her Majesty’s Stationery Office or from the Office for Official Publications of the European Communities, L/2985, Luxembourg. The Regulations revoke the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971, as amended, in so far as they relate to applications for product licences for veterinary medicinal products (regulation 6 and Schedule 3).

Read the full note and every offence in this 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 0.55.

Basis
the penalty comes from the enabling Act rather than from this instrument
Confidence
0.55 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