UK Offence Report

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

regulation 7(4)(a) of The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

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

3 insert the following paragraph— 3A Any person who is the holder of

a marketing authorization who fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003 shall be guilty of an offence. ; and

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 This is the text as originally made; later amendments are not shown here.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 7(4)(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. On these words an offence is committed where a person fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003.
  2. Not doing what the provision requires under the Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003, by the time it requires it to be done.
  3. 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
8 September 2003
In force from
1 October 2003
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 Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1995 (“the Marketing Authorisations Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”) and various other statutory instruments relating to medicinal products. The Marketing Authorisations Regulations implemented in part the following provisions of European Community law: Council Directives 65/65/EEC, 75/318/EEC, 75/319/EEC and the Regulations adopted by the Commission under Article 15 of that Directive, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/26/EEC, 92/27/EEC and 92/73/EEC, now repealed and re-enacted by Directive 2001/83/EC (“the 2001 Directive”), and Council Regulation (EEC) No. 2309/93 and the Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation. They provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization and for procedures for consideration, revocation, suspension and related matters. Regulation 7 of these Regulations amends the Marketing Authorisations Regulations as a consequence of— a Commission Regulations (EC) No. 1084/2003 and No. 1085/2003, which make provision in relation to variations of marketing authorizations, including the adoption of urgent safety restrictions by competent authorities, and b the adoption of Commission Directive 2003/63/EC, which amends the 2001 Directive by substituting a new Annex I setting out standards and protocols in respect of the testing of medicinal products for which applications for marketing authorization are made. Regulations 2 to 6 amend the Medicines Act and various statutory instruments, so as to amend references to the 2001 Directive as a consequence of the adoption of Commission Directive 2003/63/EC. The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorizations, licences and certificates in respect of medicinal products for human use and for certain other fees arising out of or relating to Community obligations in relation to such products. Regulations 8, 10 to 12 make changes to the provisions for fees for applications for marketing authorizations, and for variations of such authorizations, as a consequence of the adoption of Commission Regulation (EC) No. 1084/2003 and Commission Directive 2003/63/EC. In particular, regulation 11 makes provision for new fees for minor variations of Type IA and Type IB and for variations to add new indications for use of a product in a different therapeutic area or in respect of a different organ or other part of the human body (“Extended Type II Complex Variation Applications”). Regulation 9 amends regulation 3A of the General Fees Regulations so as to make provision for fees in respect of meetings at which the licensing authority provide scientific advice to potential applicants for variations to marketing authorizations. Regulation 13 amends Schedule 5 of the General Fees Regulations, which relates to refunds and waivers. Regulation 13(2) makes provision for the waiver of fees payable in connection with meetings at which the licensing authority provide scientific advice to potential applicants for marketing authorizations or variations of such authorizations. Regulation 13(3) provides for the waiver of fees for applications for variations of marketing authorizations which result from urgent safety restrictions imposed by the licensing authority. 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, Room 16-107, 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