Offences: breach of regulations and false information

Q: Is regulation 45U(1) of The Human Medicines (Amendment) Regulations 2013 a strict liability offence?

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.

regulation 45U(1) of The Human Medicines (Amendment) Regulations 2013

Status not determined
Strict liability
Either way
Drugs and medicines

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 A person is guilty of an offence if the person imports, manufactures or distributes an active substance in breach of regulation 45M(1).

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 This is the text as originally made; later amendments are not shown here.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 45U(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.

On these words an offence is committed where a person imports, manufactures or distributes an active substance in breach of regulation 45M(1).
Selling the goods under the Human Medicines (Amendment) Regulations 2013 where the instrument prohibits the sale outright.
Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
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: Unlimited
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.

Drug offences: definitive guideline Magistrates' courts and the Crown Court in England and Wales
Covers importation, supply, production and possession of controlled drugs, with sentencing driven by drug class and the offender's role.
Imposition of community and custodial sentences: definitive guideline All courts in England and Wales
When a community order or custody is justified at all, and the presumption against short custodial sentences.
Reduction in sentence for a guilty plea: definitive guideline All courts in England and Wales · in force from 1 June 2017
The sliding scale of credit for pleading guilty, from one third at the first stage of proceedings downwards.
General guideline: overarching principles All courts in England and Wales · in force from 1 October 2019
The guideline a court uses when there is no offence-specific guideline, which is the position for the overwhelming majority of offences created by statutory instrument. It sets out how culpability and harm are assessed from first principles.
Totality: definitive guideline All courts in England and Wales
How to sentence more than one offence at once so that the total is just and proportionate - frequently in point here, because regulatory prosecutions commonly charge several breaches of the same instrument.

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: 22 July 2013
In force from: Not determined
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

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) in order to implement— Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“Directive 2011/62/EU”); Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (“the Implementing Regulation”); an EU Corrigendum which corrects an error in Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (“the EU Corrigendum). The majority of provisions in these Regulations introduce new provisions into the 2012 Regulations in relation to brokers, active substances and the sale of medicinal products at a distance in order to implement Directive 2011/62/EU. In particular— regulation 3 updates the general interpretation provisions to insert new definitions; regulations 4 to 6, 9 to 15, 17, 19 and 20 amend provisions relating to manufacturers or wholesalers of medicinal products, marketing authorisations and traditional herbal registrations; regulation 16 inserts new provisions relating to brokers of medicinal products and importers, manufacturers or distributors of active substances; regulation 28 inserts new provisions relating to the sale at a distance of medicinal products; regulation 30, 34 and 35 make consequential amendments related active substances; regulation 32 amends provisions so that brokers of medicinal products and importers, manufacturers and distributors of active substances can apply for certain decisions to be reviewed upon oral representations; and regulation 33 inserts a new Schedule in relation to information requirements for registration in relation to active substances. Regulations 21, 23 and 25 amend the 2012 Regulations in order to provide sanctions for breaches of obligations and requirements imposed by the Implementing Regulation in relation to pharmacovigilance activities and regulation 22 makes consequential changes to remove duplication of obligations. Regulations 18 and 24 make amendments to ensure that cross-references to Regulation (EC) No 726/2004 that were amended by the EU Corrigendum are correctly reflected in the 2012 Regulations. Regulations 7, 26 and 27 insert new provisions into the 2012 Regulations that enable physiotherapist independent prescribers and podiatrist independent prescribers to mix, sell or supply certain types of prescription only medicines. Regulation 8 amends the 2012 Regulations so that where a licence holder wishes to make oral representations to the licensing authority a fee is payable by the licence holder. Regulations 29 and 31 amend the 2012 Regulations to ensure that regulations related to inspections, sampling and seizure and the review of provisions can be applied in relation to new provisions for brokers, the importation, manufacture and distribution of active substances and the sale of medicines to the public at a distance.

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

This provision on legislation.gov.uk The authoritative text. Check it before relying on anything here.
The Human Medicines (Amendment) Regulations 2013 Every offence this instrument creates, and its explanatory note
Drugs and medicinesOther offences on the same subject
Offences created in 2013