UK Offence Report

Breach of pharmacovigilance condition

regulation 97(1) of The Human Medicines (Amendment) (No. 2) Regulations 2014

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 The holder of

a marketing authorisation or

a parallel import licence is guilty of an offence if the holder fails to comply with

a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of

a UK marketing authorisation or parallel import licence: general).

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 This is the text as originally made; later amendments are not shown here.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 holder
Conduct
importing or exporting without authority
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 holder 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 97(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. Moving the goods across the border under the Human Medicines (Amendment) (No. 2) Regulations 2014 without the licence the instrument requires.
  2. Holding a licence for one consignment and using it for another.
  3. Sending goods in transit through the United Kingdom, where the provision catches transit as well as import and export.

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
16 July 2014
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

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”). In particular, regulations 3 to 21 and 26 set out how parallel import licences are granted. Regulations 22(a) and 23 amend provisions in the 2012 Regulations on the recognition of prescriptions issued by healthcare professionals in EEA States to make it clear that the rules also apply to prescriptions issued in Switzerland. Regulations 22(b) and 27 insert a definition of “school” and amend Schedule 17 of the 2012 Regulations so that inhalers containing salbutamol can be supplied in schools in an emergency by persons trained to administer them to pupils who are known to require such medication. Regulations 24 and 29 amend the requirements for advertisements for medicines that are aimed at persons qualified to prescribe or supply such products. Regulation 24 enables advertisements for medicines available without a prescription to contain a website address where information on adverse reactions, precautions, contra-indications and methods of use can be found as an alternative to providing that information on the face of the advertisement. Regulation 25 amends the 2012 Regulations to ensure that the new provisions on inhalers containing salbutamol are subject to review by the Secretary of State. Regulation 28 amends the information that must be contained in the package leaflet that accompanies a medicine. Paragraph (2) corrects an error and paragraph (3) substitutes a general requirement to include text on adverse event reporting in place of a requirement to include prescribed text. Regulation 29 enables advertisements to include relevant entries from the medicine’s summary of product characteristics as an alternative to a summary of those entries. A full impact assessment has not been produced for this instrument as no, or no significant, impact on private, public or voluntary sectors is foreseen.

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