UK Offence Report

3 Without prejudice to any other sanction which may be available for the enforcement of conditions attaching…

paragraph 3 of SCHEDULE 3 of The Medicines (Traditional Herbal Medicinal Products for Human Use) 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

3 Without prejudice to any other sanction which may be available for the enforcement of conditions attaching to traditional herbal registrations, any holder of

a traditional herbal registration for

a traditional herbal medicinal product who contravenes any condition of the registration 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 This is the text as originally made; later amendments are not shown here.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
breaching a condition of a licence, permit or consent
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

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

What would breach paragraph 3 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. On these words an offence is committed where a person contravenes any condition of the registration.
  2. Holding a valid licence but doing the thing it allows outside the hours, place or limits its conditions set under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005.
  3. Failing to do something a condition positively requires - a record, a notification, a monitoring step - even though the licensed activity itself is carried on properly.

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

The Ministry of Justice records offences under this instrument against offence code 9810 — 09810 - Triable either way offences under Medicines (Traditional Herbal Medicinal Products For Human Use) Regulations 2005. That code may cover several provisions of the instrument, so a count against it is not a count of prosecutions under this provision alone.

No published per-offence figure was found for this provision. Offences created by statutory instrument very largely do not have their own code in the MoJ’s Outcomes by Offence data tool. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Status not determined
Made
6 October 2005
In force from
30 October 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 implement Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “2001 Directive”). Directive 2004/24/EC amended the 2001 Directive to introduce a simplified registration procedure for the marketing of traditional herbal medicinal products for human use. These Regulations introduce a scheme of traditional herbal registrations (defined in Regulation 2). Regulation 3 provides that the licensing authority established under section 6 of the Medicines Act 1968 (consisting of the Secretary of State for Health, the Secretary of State for Environment and Rural Affairs, and the Northern Ireland Department for Health, Social Services and Public Safety and the Northern Ireland Department for Agriculture and Rural Development) will perform the functions of the competent authority in relation to the provisions of the 2001 Directive which apply to traditional herbal medicinal products. Regulation 4(1) requires all traditional herbal medicinal products placed on the market or distributed by wholesale dealing to be registered in accordance with these Regulations. Regulation 4(2) and Schedule 1 set out exemptions under which traditional herbal medicinal products may be supplied or administered without a traditional herbal registration provided the conditions set out in Schedule 1 are complied with. In particular, doctors, dentists and supplementary prescribers may prepare, or order to be prepared, traditional herbal medicinal products to be used by their individual patients. Regulations 5 to 7 and Schedule 2 make provision for applications for the grant, renewal and variation of traditional herbal registrations, and for the licensing authority to revoke, vary or suspend traditional herbal registrations. In particular, Schedule 2 makes provision for reference to the appropriate committee of decisions to refuse traditional herbal registrations, proposals to refer applications in certain circumstances to the Committee for Herbal Medicinal Products, and to revoke, vary or suspend a registration. Regulation 8 makes provision for the licensing authority to impose an urgent safety restriction on the holder of a traditional herbal registration. Regulation 9 imposes obligations on the holders of traditional herbal registrations. Regulations 9(6) and 11 and Schedules 3 and 4, make provision for enforcement and related matters, including powers of inspection, offences and penalties for breaches of the Regulations. Regulation 12 and Schedule 5 impose labelling requirements for traditional herbal medicinal products which are prepared or dispensed in accordance with a prescription, or available only from a pharmacy. Regulations 10 and 12 and Schedules 6 and 7, contain miscellaneous provisions for the consequential amendment of legislation and for transitional arrangements. A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of Directive 2004/24/EC, have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Read the full note and every offence in this instrument

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