UK Offence Report

Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)

paragraph 91(a) of SCHEDULE 2 of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

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

a for paragraph (1) substitute— 1 A person who is— a the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or b a parallel distributor, is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2). ;

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 This is the text as originally made; later amendments are not shown here.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
failing to comply with a notice or direction
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 paragraph 91(a) of SCHEDULE 2?

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. On these words an offence is committed where a person fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).
  2. Being served with a notice under the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and doing nothing by the date it specifies.
  3. Doing part of what the notice requires, where it required all of it.
  4. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

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 December 2020
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 are made in exercise of the powers conferred by section 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a), (b), (c), (d), (f) and (g) and (6)) arising from the withdrawal of the United Kingdom from the European Union and to make provision in connection with the Protocol on Ireland/Northern Ireland in the withdrawal agreement. They are also made under paragraphs 1(1) and 7(2) of Schedule 4 to the European Union (Withdrawal) Act 2018, insofar as they make provision in relation to fees, and paragraph 21 of Schedule 7 in relation to consequential and transitional arrangements. These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. The majority of the instrument (regulation 4 and Schedule 2) amends the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) which itself amends the Human Medicines Regulations 2012 (S.I. 2012/1916) and the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190). Regulation 3 and Schedule 1 amend the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744) which itself amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031). Regulation 2 amends the Good Laboratory Practice Regulations 1999 (S.I. 1999/3106), and regulation 5 and Schedule 3 amend the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385) to remove superseded provisions. An impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published alongside this instrument at www.legislation.gov.uk.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

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