UK Offence Report

Amendment of Schedule 3 to the 1994 Regulations

regulation 3(9) of The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (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

3 Where the holder of

a United Kingdom marketing authorization (“H”) has instigated or conducted

a paediatric clinical trial in the United Kingdom which ended on or after 26th January 2007 but before 29th December 2008 in respect of the product to which the authorization relates and the trial is not included in

a paediatric investigation plan, H shall be guilty of an offence if H fails to submit the results of that trial to the EMEA on or before 29th June 2009, as required by Article 41(2) of the Paediatric Regulation.

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 This is the text as originally made; later amendments are not shown here.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 do something the instrument requires
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 3(9)?

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. Not doing what the provision requires under the Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008, by the time it requires it to be done.
  2. Doing it, but not in the manner or to the standard the instrument specifies.

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
3 December 2008
In force from
29 December 2008
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 provide for the enforcement in the United Kingdom of Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, as amended by Regulation (EC) No 1902/2006 of the European Parliament and of the Council amending Regulation 1901/2006 on medicinal products for paediatric use (the Paediatric Regulation). The Paediatric Regulation establishes a scheme of obligations and incentives to encourage the development of, and improve access to, medicines for children. The Paediatric Regulation is enforced through amendments to the Medicines for Human Use (Marketing Authorisation Etc.) Regulations (“the 1994 Regulations”). The 1994 Regulations are the primary piece of legislation through which Community obligations in relation to medicines are implemented. These Regulations also further amend the 1994 Regulations in connection with transposition of Directive 2001/83 of the European Parliament and Council on the Community Code relating to medicinal products for human use. Regulation 2 amends regulation 1 of the 1994 Regulations to update references to Community legislation amended by the Paediatric Regulation; and to identify the Paediatric Regulation as a “relevant Community Provision” for the purpose of the 1994 Regulations. Regulation 3 amends Schedule 3 to the 1994 Regulations by inserting various additional criminal offences through which provisions of the Paediatric Regulation can be enforced and by clarifying certain aspects of the information-reporting obligations in that Schedule. Regulation 4 updates references to Community legislation in the Medicines Act 1968 to include the Paediatric Regulation. Regulation 5 corrects a typographical error in the Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008. A full impact assessment has not been produced for this instrument as no impact on the private and 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