UK Offence Report

Contravention of The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments)…

the instrument as a whole of The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992

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 This is the text as originally made; later amendments are not shown here.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 (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992.

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
12 March 1992
In force from
3 April 1992
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 further amend the Medicines (Applications for Product Licences and Clinical Trial Certificates and Animal Test Certificates) Regulations 1971 and the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 by adding to the requirements as to particulars to be contained in, or to accompany, an application for the grant or renewal of a product licence, so implementing in part Council Directives— 89/342/EEC relating to immunological products (OJ No. L142, 25.5.1989, p.14) (Regulations 2(a), 2(b), 3 and 4 which implement articles 1, 2 and 3 of that Directive); 89/343/EEC relating to radiopharmaceuticals (OJ No. L142, 25.5.1989, p.16) (Regulations 2(c), 3 and 4 which implement in part articles 1, 2, 3 and 4 of that Directive); and 89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No. L181, 28.6.1989, p.44) (Regulations 2(a), 3 and 4 which implement articles 1 and 2 of that Directive); by imposing special conditions for applications for product licences in respect of these types of product. These Directives extend the scope of Council Directives 65/65/EEC (OJ No. 22, 9.2.1965 p.369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p.13) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, to cover such products which had previously been excluded byArticle 34 of Council Directive 75/319/EEC.

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 0.50.

Basis
the penalty comes from the enabling Act rather than from this instrument
Confidence
0.50 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