{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/regulation-2",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/regulation-2.json",
  "legislation": "uksi/1997/654",
  "legislation_title": "The Good Laboratory Practice Regulations 1997",
  "legislation_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Interpretation",
  "text": "(1) In these Regulations, unless the context otherwise requires—\n“batch” means a specific quantity or lot of a test or reference substance produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such;\n“the GLP Inspection and Verification Directive” means Council Directive 88/320/EEC of 9th June 1988 on the inspection and verification of Good Laboratory Practice (GLP), as amended by Commission Directive 90/18/EEC of 18th December 1989 adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP);\n“laboratory” means a test facility which conducts or which intends to conduct safety studies;\n“monitoring authority” means any national authority which is responsible (either solely or jointly with other such authorities) for monitoring adherence to the principles of good laboratory practice;\n“OECD” means the Organisation for Economic Co-operation and Development;\n“OECD test guideline” means a test guideline which the OECD has recommended for use in its member countries;\n“operator”, in relation to a laboratory, means the person having control of the laboratory;\n“premises”, in relation to a laboratory, includes field sites at which safety studies are conducted;\n“principles of good laboratory practice” means the principles of good laboratory practice set out in Schedule 1 to these Regulations, which are based on the principles of good laboratory practice contained in Annex 2 to the Decision of the Council of the OECD of 12th May 1981 on the mutual acceptance of data for the evaluation of chemical products, read with the guidance on inspection procedures and study audits set out in Schedule 2 to these Regulations, which is based on Annex B of the GLP Inspection and Verification Directive;\n“quality assurance programme” means an internal control system designed to ascertain that the safety study is in compliance with these principles of good laboratory practice;\n“raw data” means all original laboratory records and documentation, or verified copies thereof, which are the result of the original observations and activities in a safety study;\n“reference substance” means any well defined substance or any mixture other than the test substance used to provide a basis for comparison with the test substance;\n“regulatory authority” means any national authority with legal responsibility for aspects of the control of chemicals;\n“safety study” means a non-clinical experiment or set of experiments—\n(a) in which a substance is examined to evaluate its safety with respect to human health, animal health or the environment; and\n(b) in relation to which a Community provision provides for the application of the principles of good laboratory practice in respect of that experiment or set of experiments;\n“sample” means any quantity of a test or reference substance;\n“specimen” means any material derived from a test system for examination, analysis, or storage;\n“sponsor” means a person or entity who commissions or pays for a safety study;\n“standard operating procedures” means written procedures which describe how to perform certain routine laboratory tests or activities normally not specified in detail in study plans or test guidelines;\n“study director” means the individual responsible for the overall conduct of the safety study;\n“study plan” means a document which defines the entire scope of the safety study;\n“test substance” means a substance or a mixture which is under investigation;\n“test system” means any animal, plant, microbial, cellular, sub-cellular, chemical, or physical system or a combination thereof used in a safety study;\n“vehicle” means any agent which serves as a carrier used to mix, disperse, or solubilise the test or reference substance to facilitate the administration to the test system.\n(2) In these Regulations, unless the context otherwise requires, a reference—\n(a) to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number;\n(b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and\n(c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L145, 11.6.88, p. 35."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L11, 13.1.90, p. 37."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "The text of this Annex is included in chapter 2 of “Good Laboratory Practice in the Testing of Chemicals—Final Report of the OECD Group of Experts on Good Laboratory Practice”(ISBN 92-64-12367-9), which may be obtained from the OECD Publications Office, 2 rue André-Pascal, 75775 Paris Cedex 16."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1997/654/regulation/2",
    "retrieved_at": "2026-10-29T12:22:49.085052+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}