UK Offence Report

False good laboratory practice instruments

regulation 12(3) of The Good Laboratory Practice Regulations 1999

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 A person who supplies to a regulatory authority— a a false good laboratory practice instrument which he knows or believes to be a false good laboratory practice instrument; b a copy of an instrument which he knows or believes to be a false good laboratory practice instrument, with the intention of inducing the regulatory authority to accept it as a genuine good laboratory practice instrument or a copy of a genuine good laboratory practice instrument 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 This is the text as originally made; later amendments are not shown here.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
selling or supplying something the instrument restricts
Fault element
Requires proof of a state of mind
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove both that the conduct happened and that it was done with the state of mind the provision names (with the intention of).

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: mens rea word in the offence-creating words: with the intention of.

What would breach regulation 12(3)?

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. Selling the goods under the Good Laboratory Practice Regulations 1999 where the instrument prohibits the sale outright.
  2. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  3. Offering for sale counts as well as selling: displaying stock is enough where the provision reaches an offer.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

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
18 November 1999
In force from
14 December 1999
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 contain the legislative measures necessary for the implementation within the United Kingdom of Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, as amended by Commission Directive 1999/11/EC adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC, and for the implementation of Council Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP), as amended by Commission Directive 1999/12/EC adapting to technical progress for a second time the Annex to Council Directive 88/320/EEC. Regulation 2 is an interpretation provision. Amongst other definitions, there is a definition of the principles of good laboratory practice, a concept which is defined with reference to the principles set out in Schedule 1 to the Regulations and the operating procedures set out in Schedule 2. Regulation 3 sets out the arrangements for enforcing compliance with the Regulations by the good laboratory practice monitoring authority (“GLPMA”). Regulation 4 contains a requirement that regulatory studies must only be conducted at test facilities which are part of the United Kingdom good laboratory practice compliance programme. Regulation 5 deals with prospective membership of the programme by test facility operators in respect of particular test facility premises, and Regulation 6 deals with full membership of the programme. Regulation 7 contains a requirement that regulatory studies shall be conducted in accordance with the principles of good laboratory practice. Where there are serious deviations from the principles, there is a procedure for serving warning notices on test facility operators requiring them to ensure that the serious deviation will not recur. Breach of such a notice is an offence, although there is an appeals procedure contained in Regulation 8, if an operator of a test facility is aggrieved by a decision to serve a warning notice on him. Regulation 9 contains the powers to enable persons duly appointed by the GLPMA to enforce compliance with the provisions of the Regulations, including powers of entry. Regulation 10 contains rules relating to the disclosure of commercially sensitive or other confidential information which may come to light as a result of enforcement action taken under the Regulations. Impeding the work of a person duly appointed by the GLPMA who is acting in pursuance of any of his functions under the Regulations is made an offence under Regulation 11. Regulation 12 contains offences relating to the production and supply to regulatory authorities of false good laboratory practice instruments. Regulation 13 relates to offences committed with the consent or connivance, or attributable to, bodies corporate or Scottish partnerships, and Regulation 14 is a general defence of due diligence in relation to any of the offences under the Regulations. Regulation 15 is a penalties provision, and Regulation 16 gives the GLPMA powers to charge fees for inspections and services under the Regulations. Regulation 17 revokes the Good Laboratory Practice Regulations 1997. A Regulatory Impact Assessment in relation to these Regulations has been prepared and copies may be obtained from the GLPMA, Room 1808, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy has also been placed in the library of each of the Houses of Parliament.

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