UK Offence Report

Offence relating to the sale and supply of starting materials for use in the manufacture of relevant…

regulation 5(1) of The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (revoked)

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 Any person who, in the course of

a business carried on by him, sells or supplies any active substance in circumstances where the active substance —

a has not been manufactured in accordance with the principles of good manufacturing practice applicable to starting materials; and

b is intended to be used by the person to whom it is sold or supplied in the manufacture of

a relevant medicinal product other than an exempt relevant medicinal product, 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 This is the text as originally made; later amendments are not shown here.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
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 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 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 5(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 (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 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
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
3 months
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
10 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 certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”), make changes to certain existing provisions which implement Directive 2001/83/EC and make consequential amendments to various enactments. These Regulations implement the requirements of the 2004 Directive insofar as they relate to the manufacture, assembly, importation and wholesale distribution of medicinal products to which those Directives apply (“relevant medicinal products”), and, as respects relevant medicinal products, replace the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, which implemented the requirements of the 2001 Directive as respects those matters. Regulation 1 concerns citation, commencement and interpretation. Regulation 2 imposes certain requirements on the holder of a manufacturer’s licence granted pursuant to section 20 of the Medicines Act 1968 (“the Act”) in connection with the manufacture and assembly of relevant medicinal products. Regulation 3 imposes certain requirements on the holder of such a licence in connection with the import of relevant medicinal products from outside the European Economic Area. Regulation 4 makes provision as to qualified persons who are responsible under the terms of the Directives for carrying out certain functions in relation to the manufacture, assembly and import from outside the European Economic Area of relevant medicinal products. Regulation 5 provides that it is an offence to supply starting materials for use in the manufacture of a relevant medicinal product (other that a relevant medicinal product to which section 1 of the Medicines for Human Use (Marketing Authorisations Etc. Regulations 1994 applies) where the starting materials have not been manufactured in accordance with the principles of good manufacturing practice. Regulation 6 and Schedules 1 and 2 set out certain additional obligations which the licensing authority may impose on manufacturer’s licence holders as “standard provisions” of their licences. Section 47 of the Act provides, save where the exceptions set out in that section of the Act apply, that “standard provisions” shall have effect as provisions of the licences granted pursuant to section 20 of the Act. Regulation 7 and Schedule 3 provide that the licensing authority may impose additional standard provisions on the holders of manufacturer’s licences which relate to vaccines, toxins and sera. Regulations 8 – 10 impose certain requirements on the holder of a wholesale dealer’s licence granted pursuant to section 20 of the Act. Regulation 11 and Schedule 4 set out certain further obligations which the licensing authority may impose on wholesale dealer’s licence holders as “standard provisions” of their licences. Regulation 12 provides that certain parts of these Regulations shall have effect as though they were made in exercise of the new regulation making powers which are inserted into section 8 of the Act by regulation 14 and Schedule 5. Regulations 13 and 14 and Schedule 5 make provision for revocations, and for consequential amendments to the Act and other enactments. Regulation 15 and Schedule 6 make certain transitional provisions. Regulatory Impact Assessments in relation to these Regulations, and a Transposition Note in relation to the implementation of the 2004 Directive, 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

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