UK Offence Report

Contravention of The Medicines (Advisory Bodies) Regulations 2005

the instrument as a whole of The Medicines (Advisory Bodies) Regulations 2005

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 This is the text as originally made; later amendments are not shown here.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 (Advisory Bodies) Regulations 2005.

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
4 April 2005
In force from
31 May 2005
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 amend the Medicines Act 1968, and related legislation, to abolish the Medicines Commission and the Committee on Safety of Medicines and to establish a new body in their place called the Commission on Human Medicines (“the Commission”). The Commission will be responsible, amongst other things, for advising the licensing authority in relation to licences under the Act and marketing authorizations under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”), granted in accordance with Directive 2001/83/EC on the Community code relating to medicinal products for human use. Regulation 2 abolishes the Medicines Commission and repeals section 2 of the Act. Regulation 3 inserts a new section 2A, which provides for establishment of the Commission and regulation 4 substitutes a new section 3 which sets out details of the membership and functions of the Commission. Regulation 5 amends section 4 of the Act as a consequence of the abolition of the Medicines Commission and to require that committees established under that section must have at least 8 members. Regulation 6 amends section 5 of the Act to make provision for the reports by the Commission and committees established under section 4 of the Act. Regulation 7 repeals Schedule 1 to the Act and inserts a new Schedule 1A, containing detailed provisions relating to the Commission and to committees established under section 4 of the Act, including: arrangements for co-opting members; appointment by the Commission and committees established under section 4 of sub-committees called Expert Advisory Groups; the delegation of functions to those Expert Advisory Groups; and miscellaneous provisions relating to staff, premises, proceedings and funding. Regulation 8 and Schedule 1 substitute new sections 21 (procedure on reference to appropriate committee) and 22 (procedure in other cases) of the Act, insert a new section 22A (hearing before person appointed by the licensing authority) and substitute a new Schedule 2 (suspension, revocation or variation of licence). These make new provision for the procedures on applications for, and decisions in respect of, licences granted under the Act; in particular for consultation of the Commission or another “appropriate committee”. Licences granted under the Act include those licences which constitute UK manufacturing and wholesale distribution authorisations under Articles 40 and 76 of Directive 2001/83/EC. Schedule 1 also makes a number of consequential amendments. Regulation 9 and Schedule 2 make amendments to the 1994 Regulations (which implement the provisions of Directive 2001/83/EC relating to marketing authorizations), including the substitution of a new Schedule 2, which sets out the procedural provisions applicable to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations and includes, in Part 3 of that Schedule, a new procedure applicable to certain applications to vary a marketing authorization. Changes are made to the scope and application of the Schedule (paragraphs 2 to 6) to take account of these new provisions and amendments to Directive 2001/83/EC made by Directive 2004/27/EC. Regulation 10 and Schedule 3 make amendments to other enactments. Regulation 11 revokes the Medicines Commission and Committees Regulations 1970 (which make provision relating to the appointment of members and committees of those bodies) and the Medicines (Committee on Safety of Medicines) Order 1970 (which established the Committee on Safety of Medicines). A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy of that assessment has been placed in the libraries of both Houses of Parliament.

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