UK Offence Report

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

regulation 3(a) of The Medicines (Provision of False or Misleading Information 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

a after paragraph

10 insert the following paragraph— 10A

1 Any person who in the course of an application for the grant, renewal or variation of

a marketing authorization for

a relevant medicinal product—

a fails to provide to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product as required by point (7) or (11) of the introduction to Annex I to the 2001 Directive; or

b provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the relevant medicinal product but which is false or misleading in

a material particular, 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 This is the text as originally made; later amendments are not shown here.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
making a false or misleading statement
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(a)?

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. Entering a figure on a form or return that is known to be wrong under the Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005.
  2. Leaving out something the form asks for, where the omission is what makes the answer misleading.
  3. Producing a document to an official that has been altered since it was issued.

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
24 June 2005
In force from
1 August 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 make amendments to: the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the Standard Provisions Regulations”), which amongst other matters set the standard conditions for licences to manufacture or distribute by way of wholesale dealing medicinal products in the United Kingdom and which implement in part Titles IV and VII of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use; and the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”), which relate to the scheme for authorising the marketing of medicinal products for human use in the United Kingdom and which implement various provisions of Directive 2001/83/EC, as amended. Regulation 2 amends the Standard Provisions Regulations. A new requirement is imposed on holders of manufacturer’s licences to keep detailed records in relation to intermediate products used in the manufacture of biological medicinal products for human use. Holders of manufacturer’s and wholesale dealer’s licences are also required to take all reasonable precautions and exercise all due diligence to ensure that any information they provide to the licensing authority which is relevant to the evaluation of the safety, quality and efficacy of medicinal products for human use that they manufacture or deal in is not false or misleading in a material particular. Manufacturers are also required to take all reasonable precautions and exercise all due diligence to ensure that the information they provide about starting materials and intermediate products used in the manufacture of medicinal products for human use is not false or misleading in a material particular. Paragraphs (2) and (4)(a) correct minor errors arising from the Medicines (Codification Amendment Etc.) Regulations 2002, which updated the references in United Kingdom legislation to certain European Community instruments relating to medicinal products for human use to take account of the adoption of Directive 2001/83/EC. Regulation 3 amends the Marketing Authorisations Regulations. It creates new criminal offences for failures to provide information relevant to the evaluation of safety, quality or efficacy of a medicinal product for human use and for the provision of information to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of medicinal products for human use but which is false or misleading in a material particular. These offences relate to obligations under Directive 2001/83/EC; in particular the obligation on applicants for authorisation to provide all information relevant to an evaluation of a product’s safety, quality and efficacy (see Article 8 and the introduction to Annex I of Directive 2001/83/EC) and to keep this information up to date (Articles 23, 24 and 106(6)) and the obligation on competent authorities to evaluate products' safety, quality and efficacy both on receipt of an application for authorisation and during the currency of a marketing authorisation (see Articles 19, 21, 24, 26, 107 and 116). A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can 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

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