UK Offence Report

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

regulation 3(4)(b) of The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

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

b after paragraph (6) insert the following paragraph— 6A Any holder of

a United Kingdom marketing authorization who fails to forward to the licensing authority any data requested by the authority pursuant to the final paragraph of Article

23 of the 2001 Directive—

a where the licensing authority have served

a written notice on the holder under regulation 7(5) in relation to the request, within the time specified in that notice; or

b where there is no such notice, promptly, 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 This is the text as originally made; later amendments are not shown here.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
an licensing authority
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 an licensing authority 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(4)(b)?

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 (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004, 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
7 December 2004
In force from
1 January 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 implement certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”), and make consequential amendments to various enactments following the adoption of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. The 2001 Directive is implemented in part by the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”). Regulation 3(2)(a)(i) and (ii) of these Regulations amends the 1994 Regulations so as to implement Article 1(21), (44), (45) and (54) of the 2004 Directive. These provisions amend the 2001 Directive so as to provide, in relation to medicinal products for human use, that– a marketing authorization holders have additional obligations to provide information and data to the competent authority (Article 1(21) of the 2004 Directive), b package leaflets accompanying such products must be drawn up in accordance with new requirements, in particular that the leaflet must reflect the results of consultations with target patient groups (Article 1(44) and (45)), and c where a change of classification of such a product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority may not refer to the results of those tests or trials, when examining a change of classification for the same substance within one year of the initial change (Article 1(54)). Regulation 3(4) creates new criminal offences for failures by marketing authorization holders to provide information in accordance with the requirements of the new paragraphs inserted by Article 1(21) of the 2004 Directive. Regulation 3(5) amends the 1994 Regulations so as to make transitional provision for the application of the amendments relating to package leaflets made by Article 1(44) and (45) of the 2004 Directive. These Regulations, except regulation 3(2)(a)(i) and (ii), (4) and (5), make amendments to the Terrorism Act 2000 and to various statutory instruments consequential on the coming into force of Title IV of Regulation (EC) No. 726/2004. This Regulation revokes and replaces Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Most of Regulation (EC) No. 726/2004 does not apply until 20th November 2005, but Title IV came into force on 20th May 2004. Title IV provides for the establishment and constitution of the European Medicines Agency (which replaces the European Agency for the Evaluation of Medicinal Products), and the constitution of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (which replace the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, respectively). A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of the 2004 Directive, have been placed in the libraries of both Houses of Parliament and copies may 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

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