UK Offence Report

5 Any person who is or, immediately before its revocation or suspension, was the holder of a marketing…

paragraph 5 of SCHEDULE 3 of The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

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

5 Any person who is or, immediately before its revocation or suspension, was the holder of

a marketing authorization who fails to comply with

a notice given to him under regulation 6(5) (notice to take all reasonably practicable steps to publish information concerning revocation or suspension or to recover possession of products affected) shall be guilty of an offence.

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 This is the text as originally made; later amendments are not shown here.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
failing to comply with a notice or direction
Fault element
Objective fault
Burden of proof
Legal burden on the defendant

The prosecution must prove that the conduct happened and that it fell below the standard the provision sets. That is an objective test - what a reasonable person in the same position would have done, not what this defendant actually thought.

What a person personally believed or intended is not the question; the standard is what was reasonable.

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: objective standard in the offence-creating words: reasonably practicable.

The defence, as drafted

as not to comply with the provisions of that authorization, it shall be a defence for him to prove— a that he had communicated the provisions relating to the authorization 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 has not been complied with.

What would breach paragraph 5 of SCHEDULE 3?

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. Being served with a notice under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and doing nothing by the date it specifies.
  2. Doing part of what the notice requires, where it required all of it.
  3. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

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.

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
8 December 1994
In force from
1 January 1995
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 for the United Kingdom, and in so far as they are concerned with medicinal products for human use, the Council Directives mentioned in regulation 1(2) in the definition of “relevant Community provisions”. They also contain provisions supplementing the provisions of Council Regulation (EEC) No. 2309/93. Both the Directives and the Regulation are concerned with the marketing of medicinal products. The Regulations provide that the functions of a member state or the competent authority of a member State under the relevant Community provisions are, except as otherwise provided, to be performed in the United Kingdom by the licensing authority (ie the Ministers in the United Kingdom concerned with health and agriculture— see sections 1 and 6 of the Medicines Act 1968) (regulation 2). They also provide that no medicinal product for human use which is subject to the relevant Community provisions may be placed on the market in the United Kingdom or be dealt with by way of wholesale dealing unless there is in force in respect of it a marketing authorization granted either by the European Commission or by the licensing authority (regulation 3). Regulations 4 to 7 and Schedules 2 and 3 provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization, the procedure for the consideration of such an application, the revocation and suspension of a marketing authorization and the suspension of the use or marketing of medicinal products and the obligations of applicants for and holders of marketing authorizations. In particular regulation 7(4) and Schedule 3 create certain offences in connection with those obligations. Regulation 8 is about the control of retail sale or supply of relevant medicinal products. Regulation 9 makes consequential and other amendments to the Medicines Acts 1968 and 1971. Schedule 1 makes certain exceptions and exemptions from the requirement to hold a marketing authorization. Schedule 4 contains provisions applying with modifications the provisions of the Medicines Act 1968 about enforcement. Schedule 5 contains provisions about the labelling of medicinal products, Schedule 6 contains transitional provisions and Schedule 7 makes consequential amendments to other regulations. An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

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