UK Offence Report

Amendment of Schedule 3 to the principal Regulations

regulation 4(1) of The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

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

1 After paragraph

1 of Schedule

3 to the principal Regulations (offences, penalties etc.) there shall be inserted the following paragraph— 1A In respect of any product which is

a relevant medicinal product, where, following

a determination under regulation 3A(4) or (5), the licensing authority serve

a notice in respect of that product on any person under regulation 3A(6) requiring him—

a to stop marketing the product from

a date specified in the notice unless or until

a marketing authorization is granted in respect of that product, if after the date specified—

i he places that product on the market, or

ii in the course of

a business carried on by him, he sells, supplies to

a member of the public or procures for sale or for supply to

a member of the public that product, without

a marketing authorization having been granted in respect of that product, he shall be guilty of an offence;

b not to place the product on the market unless or until

a marketing authorization is granted in respect of that product, if he thereafter places the product on the market without

a marketing authorization having been granted in respect of that product, he 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 This is the text as originally made; later amendments are not shown here.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
an licensing authority
Conduct
selling or supplying something the instrument restricts
Fault element
Strict liability
Burden of proof
No statutory defence — prosecution proves everything

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 an licensing authority 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 states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 4(1)?

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. Selling the goods under the Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000 where the instrument prohibits the sale outright.
  2. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  3. Offering for sale counts as well as selling: displaying stock is enough where the provision reaches an offer.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated here: this instrument amends another one, and the penalty for the offence is in the instrument being amended.

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 February 2000
In force from
1 March 2000
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 amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the principal Regulations”), which implemented in respect of the United Kingdom a range of European Community measures relating to the marketing of medicinal products for human use. Regulation 2 amends the definition of “the relevant Community provisions” in the principal Regulations, updating the reference to Council Directive 75/318/EEC on the approximation of the laws of member States relating to analytical, pharmacotoxological and clinical standards and protocols in respect of the testing of medicinal products. As a result, it now refers to that Directive as amended by Commission Directives 1999/82/EC and 1999/83/EC. Commission Directive 1999/82/EC relates to compliance with the European Commission’s “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicial Products” which is applied to new applications for marketing authorizations for medicinal products from 1st July 2000 and to all marketing authorizations from 1st March 2001. The principal Regulations are also amended so that, from the latter date, a holder of a marketing authorization who fails to introduce any changes or make any amendments that may be required to demonstrate compliance with that Guideline may be guilty of an offence (regulation 4(2)). Regulation 3 inserts a new regulation 3A into the principal Regulations. It contains a new statutory procedure for determinations by the licensing authority as defined in the Medicines Act 1968, as to whether or not a product is a “relevant medicinal product”. The procedure allows for representations to be made against provisional determinations, and for those representations to be considered by a review panel appointed by the licensing authority. Once a final determination has been made, the licensing authority may serve a notice requiring a person not to place a product determined to be a relevant medicinal product on the market, or to stop marketing it from a date specified, unless or until a marketing authorization has been granted in respect of the product. A new provision is inserted into Schedule 3 of the principal Regulations making breach of such a notice an offence in respect of relevant medicinal products (regulation 4(1)). Regulation 5 makes a minor amendment to the special warnings which must be included on the packaging of medicinal products containing paracetamol on the general sale list, other than products prepared or dispensed in accordance with a prescription given by a medical practitioner.

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 0.96.

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