UK Offence Report

Other Schedules to have effect

regulation 20 of Medicines (Homoeopathic Medicinal Products for Human Use) Amendment 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

8 Subject to paragraph 14, any person who is the holder of

a certificate of registration who fails to ensure appropriate and continued supplies pursuant to the second paragraph of Article

81 of the 2001 Directive shall be guilty of an offence. 9

1 Subject to paragraph 14, any person who in the course of an application for the grant, renewal or variation of

a certificate of registration for

a homoeopathic medicinal product—

a fails to provide to the licensing authority any information which is relevant to an evaluation of the quality of the homoeopathic medicinal product as required by Article

15 of the 2001 Directive; or

b provides to the licensing authority any information which is relevant to an evaluation of the quality of the homoeopathic medicinal product but which is false or misleading in

a material particular, 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 This is the text as originally made; later amendments are not shown here.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
making a false or misleading statement
Fault element
Mixed — some elements strict, some not
Burden of proof
Legal burden on the defendant

The prosecution must prove the conduct, and - for those elements the provision qualifies - the state of mind it names. The remaining elements carry no fault requirement, so they are strict.

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 fault word in the offence-creating words, but the surrounding provision uses reasonable cause to believe - which element it governs was not determined.

The defence, as drafted

d as not to comply with the provisions of that certificate, it shall be a defence for him to prove— a that he had communicated the provisions relating to the certificate of 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. 14 1 A pers

What would breach regulation 20?

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. Entering a figure on a form or return that is known to be wrong under the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005.
  2. Leaving out something the form asks for, where the omission is what makes the answer misleading.
  3. Producing a document to an official that has been altered since it was issued.

Penalty

Mode of trial
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
Not determined
Maximum prison (on indictment)
2 years

expressed as the statutory maximum (the prescribed sum): the same words mean £5,000 in England and Wales and £10,000 in Scotland.

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
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 make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”) and consequential amendments to the Medicines Act and other Regulations. The Homoeopathic Regulations implemented in part Council Directive 92/73/EEC (now repealed and re-enacted in Directive 2001/83/EC) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. The Homoeopathic Regulations also make provision for capital fees payable for applications for the grant and variation of certificates of registration and for periodic fees payable by holders of these certificates. Directive 2001/83/EC has now been amended by Directive 2004/27/EC. Regulations 5, 7, 9 and 10 to 18 and provisions in regulations 2, 6, 8, 20 and 21 in part implement the changes made by Directive 2004/27/EC. Regulations 2, 5, 6, 13, 14, 16, 17 and 18 make changes necessitated by the extension of the mutual recognition procedure and decentralised procedure set out in Article 28 of Directive 2001/83/EC to homoeopathic medicinal products registered under the simplified scheme. In particular new capital fees for decentralised procedure and incoming and outgoing mutual recognition applications are introduced by regulations 17 and 18 which amend Schedule 2 to the Homoeopathic Regulations and insert new Schedule 2A respectively. Regulation 9 amends regulation 8 of the Homoeopathic Regulations dealing with renewal of certificates of registration in order to implement the changes to Article 24 of Directive 2001/83/EC and the insertion of Article 23a. Regulation 10 makes provision for the licensing authority to revoke, suspend or compulsorily vary a certificate of registration, if this is in accordance with the provisions of Directive 2001/83/EC, as required by Article 116 of the Directive. Regulations 7, 8, 11 and 12 contain consequential amendments. Regulations 8(3) and 20 insert a new Schedule 6 to the Homoeopathic Regulations which sets out offences for breaches of the Homoeopathic Regulations. The Schedule contains some new offences introduced to implement changes to Directive 2001/83/EC but also includes offences that were previously applied by virtue of sections 7 and 45 of the Medicines Act 1968 (the “Act”) as applied to homoeopathic medicinal products. Regulation 21 inserts Schedule 1 which amends section 7 of the Act so that this section no longer applies to medicinal products to which the Homoeopathic Regulations apply. Regulations 15 and 20 also insert a new Schedule 7 to the Homoeopathic Regulations which provides that the requirement introduced by Directive 2004/27/EC for the name of a homoeopathic medicinal product to be in Braille format on the label, and the changes made to what information may be on the label of a product with a certificate of registration, shall not apply until 30th October 2010 for products granted a certificate of registration before 30th October 2005. Regulation 19 and in part regulations 6, 9, 10 and 20 make provision for the procedures on applications for, and decisions in respect of, certificates of registration, in particular for consultation of a committee established under the Act, or the Commission on Human Medicines. Changes to the procedures have been made as a consequence of amendments made by the Medicines (Advisory Bodies) Regulations 2005 which amend the Act to, amongst other things, abolish the Medicines Commission. Regulations 3, 4 and provisions in regulation 2 correct minor errors and omissions in the Homoeopathic Regulations. Regulation 21 and Schedule 1 amend the Medicines (Labelling) Regulations 1976 and the Medicines (Leaflets) Regulations 1977 so that these Regulations do not apply to homoeopathic medicinal products to which the Homoeopathic Regulations apply. The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995 is amended to change the definition of a homoeopathic medicinal product (amended by Directive 2004/27/EC), to remove the reference to Directive 92/74/EEC (this Directive which related to veterinary medicinal products has been repealed), and to extend the remit of the Advisory Board on the Registration of Homoeopathic Products to include consideration of proposals to compulsorily vary a certificate of registration. A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of Directive 2004/27/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 0.96.

Basis
the provision says a person is “guilty of an offence”
Confidence
0.96 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