UK Offence Report

The Good Laboratory Practice Regulations 1997

UK Statutory Instrument 1997 No. 654 — creates 3 criminal offences.

3offences created
0recorded in force
3revoked
Made
6 March 1997
In force from
1 April 1997
Extent
Not stated
Subject
Health and safety, environment, waste and fisheries
Made under
European Communities Act 1972, Finance Act 1973

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations contain the legislative measures necessary for the implementation of Council Directive 87/18/EEC on the harmonization 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 (OJ No. L15, 17.1.87, p. 29), Council Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP) and Commission Directive 90/18/EEC adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice. 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 the Schedule 1 to the Regulations and the operating procedures set out in Schedule 2 to the Regulations. Regulation 3 sets out certain functions of the Secretary of State, including enforcing compliance with the Regulations. Regulation 4 contains a requirement that safety studies covered by the Regulations must only be conducted at laboratories which are part of the United Kingdom good laboratory practice compliance programme. Regulation 5 deals with prospective membership of the programme by laboratory operators in respect of particular laboratory premises, and regulation 6 deals with full membership of the programme. Regulation 7 contains a requirement that safety studies covered by the Regulations 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 laboratory 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 laboratory is aggrieved by a decision to serve a warning notice on him. Regulation 9 deals with the powers of inspectors who are discharging the enforcement functions of the Secretary of State. The conditions under which inspectors are to be appointed are governed by regulation 10. Regulation 11 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 an inspector who is acting in pursuance of any of his functions under the Regulations is made an offence under regulation 12. 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 contained in the Regulations. Regulation 15 is a penalties provision, and regulation 16 gives the Secretary of State powers to charge fees to cover the cost of carrying out inspections and study audits. Regulations 17 to 19 contain a set of consequential amendments to other Regulations. An assessment of the cost to business of complying with these Regulations has been prepared and copies may be obtained from the Good Laboratory Practice Monitoring Authority, Room 1801, 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.

Offences created by this instrument

What Parliament said about it

Hansard was searched for this instrument by name and returned nothing. That is the ordinary outcome: an instrument laid under the negative procedure is usually never debated, and becomes law without a word said about it in either House.

How Parliament handled it

Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.

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