HEALTH AND SAFETY Citation and commencement 1 These Regulations may be cited as the Good Laboratory Practice Regulations 1997 and shall come into force on 1st April 1997. Interpretation 2 1 In these Regulations, unless the context otherwise requires— “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; “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) ; “laboratory” means a test facility which conducts or which intends to conduct safety studies; “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; “ OECD ” means the Organisation for Economic Co-operation and Development; “OECD test guideline” means a test guideline which the OECD has recommended for use in its member countries; “operator”, in relation to a laboratory, means the person having control of the laboratory; “premises”, in relation to a laboratory, includes field sites at which safety studies are conducted; “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; “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; “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; “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; “regulatory authority” means any national authority with legal responsibility for aspects of the control of chemicals; “safety study” means a non-clinical experiment or set of experiments— in which a substance is examined to evaluate its safety with respect to human health, animal health or the environment; and 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; “sample” means any quantity of a test or reference substance; “specimen” means any material derived from a test system for examination, analysis, or storage; “sponsor” means a person or entity who commissions or pays for a safety study; “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; “study director” means the individual responsible for the overall conduct of the safety study; “study plan” means a document which defines the entire scope of the safety study; “test substance” means a substance or a mixture which is under investigation; “test system” means any animal, plant, microbial, cellular, sub-cellular, chemical, or physical system or a combination thereof used in a safety study; “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. 2 In these Regulations, unless the context otherwise requires, a reference— a to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number; b in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and c in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter. Functions of the Secretary of State 3 The Secretary of State— a is designated as the authority within the United Kingdom responsible for— i the verification of compliance with the principles of good laboratory practice within the United Kingdom, ii the inspection of laboratories within the United Kingdom and the audit of studies carried out by laboratories to assess compliance with the principles of good laboratory practice, and iii any other functions of the United Kingdom’s good laboratory practice monitoring authority arising out of or related to any Community obligation or the United Kingdom’s enjoyment of rights deriving from the Community’s cooperation with the OECD under or by virtue of the Treaties; and b shall enforce compliance with these Regulations. Requirement to be a member or a prospective member of the United Kingdom good laboratory practice compliance programme 4 A safety study shall not be conducted at any premises of a laboratory unless— a the operator of the laboratory is regarded by virtue of regulation 5 or 6 as a member or a prospective member of the United Kingdom good laboratory practice compliance programme; and b the operator’s membership or prospective membership of that programme is or is partly in respect of those premises, and if a safety study is conducted at any premises of a laboratory in contravention of this regulation, the operator of that laboratory shall be guilty of an offence. Prospective membership of the United Kingdom good laboratory practice compliance programme 5 1 An operator of a laboratory shall, for the purposes of these Regulations, be regarded as being a prospective member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises only if— a he has informed the Secretary of State by notice in writing of the intention to conduct safety studies at those premises; b the Secretary of State has in writing— i acknowledged receipt of that notification, and ii informed the operator that he is a prospective member of the programme in respect of those premises, and he has not ceased to be regarded as a prospective member of the programme in respect of those premises by virtue of paragraph (2). 2 Subject to paragraph (3), an operator of a laboratory shall cease to be regarded as a prospective member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if— a he is admitted to membership of the programme in respect of those premises by the Secretary of State; b he informs the Secretary of State in writing that he no longer conducts or intends to conduct safety studies at those premises; or c the Secretary of State informs him in writing that he is not prepared to admit him to membership of the programme in respect of those premises. 3 The Secretary of State shall, before informing a prospective member of the United Kingdom good laboratory practice compliance programme under paragraph (2)(c) that he is not prepared to admit him to membership of the programme in respect of particular laboratory premises— a inform the prospective member that he is considering taking such action and explain to him in writing the reasons why such action is being considered; b give the operator a specified period within which to make representations to him; and c consider any representations which are duly made and not withdrawn, unless either there is a failure to adhere to the principles of good laboratory practice at those premises which, in the opinion of the Secretary of State, may contribute towards precipitating a danger to animal or human health or to the environment or in order to ensure fulfilment of any Community obligation, it is necessary for the Secretary of State to inform the prospective member immediately that he is not prepared to admit him to membership of the programme in respect of those premises. Membership of the United Kingdom good laboratory practice compliance programme 6 1 Subject to paragraph (2) and except where paragraph (5) applies, the operator of a laboratory shall be regarded as being a member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if— a he is regarded by the Secretary of State as being a member of the programme in respect of those premises immediately before these Regulations come into force; or b after having inspected those premises, the Secretary of State has informed the operator in writing that he is admitting the operator to membership of the programme in respect of those premises. 2 The operator of a laboratory shall cease to be a member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if— a he has informed the Secretary of State by notice in writing that safety studies are no longer conducted at those premises; or b membership of the programme in respect of those premises has been withdrawn from him by the Secretary of State in accordance with paragraph (3). 3 Subject to paragraph (4), the Secretary of State may by a notice in writing served on the operator of a laboratory withdraw the operator’s membership of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if— a the operator is, in the opinion of the Secretary of State, not capable of ensuring that the principles of good laboratory practice are adhered to at those premises; or b at those premises there is a failure to adhere to the principles of good laboratory practice which, in the opinion of the Secretary of State, may contribute towards precipitating a danger to animal or human health or to the environment. 4 Before serving a notice on an operator of a laboratory under paragraph (3)(a), the Secretary of State shall— a inform the operator in writing that he is considering serving such a notice and explain to him in writing the reasons why he is considering serving such a notice; b give the operator a specified period within which to make representations to him; and c consider any representations which are duly made and not withdrawn, unless, in order to ensure fulfilment of any Community obligation, it is necessary for the Secretary of State to serve the notice immediately. 5 Where membership of the United Kingdom good laboratory practice compliance programme has been withdrawn from an operator of a laboratory in respect of particular laboratory premises in accordance with paragraph (3), he shall again be regarded as being a member of that programme in respect of those premises if— a he has informed the Secretary of State by notice in writing of the intention to conduct further safety studies at those premises; b the Secretary of State is of the opinion— i if membership of the good laboratory practice compliance programme was withdrawn on the grounds set out in paragraph (3)(a), that the operator is capable of ensuring that the principles of good laboratory practice are adhered to at those premises, or ii if membership of the good laboratory compliance programme was withdrawn on the grounds set out in paragraph (3)(b), that the possible danger to animal or human health or to the environment which led to membership being withdrawn is no longer present; and c the Secretary of State has informed the operator by notice in writing of his readmission to membership of the programme. Requirement to adhere to the principles of good laboratory practice 7 1 No person shall conduct a safety study at any premises of a laboratory unless with regard to that study the principles of good laboratory practice are adhered to— a as respects the organisational structure surrounding the study; and b as respects the conditions under which the study is planned, performed, monitored, recorded and reported. 2 If the Secretary of State has reasonable grounds for believing that a person has contravened paragraph (1) and is responsible for a serious deviation from the principles of good laboratory practice which may have affected the validity of a safety study, he may by a notice served on the operator of the laboratory at whose premises the alleged contravention took place (in these Regulations referred to as a “warning notice”)— a state the Secretary of State’s grounds for believing that the person— i has contravened paragraph (1), and ii is responsible for a serious deviation from the principles of good laboratory practice which may have affected the validity of a safety study; b specify the measures which, in the opinion of the Secretary of State, the operator of the laboratory must take in order to ensure that the serious deviation from the principles of good laboratory practice which may have affected the validity of a safety study will not recur; c require the operator of the laboratory to take those measures, or measures which are at least equivalent to them, within such period as may be specified in the warning notice; and d inform the operator of the laboratory of— i his right of appeal against the warning notice under regulation 8, ii the period within which such an appeal may be brought, and iii the effect that such an appeal will have on any criminal proceedings relating to the operator’s alleged failure to comply with the warning notice. 3 Any operator of a laboratory who fails to comply with a warning notice shall, unless that notice has been withdrawn by the Secretary of State or cancelled by a court, be guilty of an offence. Appeals against warning notices 8 1 An operator of a laboratory who is aggrieved by a decision to serve a warning notice on him may appeal— a in England, Wales or Northern Ireland, to a magistrates' court, and such an appeal shall be by way of complaint for an order; or b in Scotland, to a sheriff, and such an appeal shall be by summary application. 2 The period during which such an appeal may be brought is— a one month from the date on which the warning notice was served on the operator desiring to appeal; or b the period specified in the warning notice, whichever ends the earlier. 3 On an appeal against a warning notice, a magistrates' or sheriff court may either cancel or affirm the notice and, if it affirms it, may do so either in its original form or with such modifications as the court may, in the circumstances, think fit. 4 Pending the final disposal of an appeal, or unless or until the appeal is withdrawn, any criminal proceedings relating to the operator’s alleged failure to comply with a warning notice shall be stayed or suspended. Powers and duties of inspectors 9 1 The Secretary of State may arrange for the discharge of any of his functions under regulation 3 by an inspector duly appointed in accordance with regulation 10. 2 In enforcing compliance with these Regulations, a duly appointed inspector shall, on production, if required, of his credentials, have a right— a at any reasonable hour to enter any premises other than premises used only as a private dwelling house which he has reason to believe it is necessary for him to visit for the purposes of enforcing compliance with these Regulations; b to carry out on those premises during that visit such inspections, examinations, tests and analyses as he considers necessary for the purpose of establishing whether or not these Regulations are being complied with; c to require the production of and take, without payment, samples of any substances on the premises for the purpose of establishing whether or not these Regulations are being complied with, but where an inspector takes a sample pursuant to this sub-paragraph, he shall give a portion of it, noted in a manner sufficient to identify it, to a responsible person at the premises; d to require the production of, inspect and take copies of or extracts from any book, document, data or record (in whatever form it is held) which may be relevant in relation to the proper exercise by the inspector of his powers to enforce compliance with these Regulations; e subject to paragraphs (6) and (7), to take possession of any books, documents, data, records (in whatever form they are held), articles or substances which are on the premises and which may be relevant in relation to the proper exercise by the inspector of his powers under these Regulations, and to detain them for as long as he considers necessary for the purposes of the proper exercise of those powers; f to question any person whom he finds on the premises and whom he has reasonable cause to believe is able to give him information which is relevant to the proper exercise by the inspector of his powers under these Regulations; g to require any person to afford him such facilities and assistance with respect to any matter within that person’s control or in relation to which that person has responsibilities as are necessary in order to enable the inspector to establish whether or not these Regulations are being complied with; h to exercise any of the functions of the Secretary of State arising out of or related to his responsibility for assessing compliance with the principles of good laboratory practice under or by virtue of these Regulations, but nothing in this paragraph shall be taken to compel the production by any person of a document of which he would, on grounds of legal professional privilege, be entitled to withhold production on an order for discovery in an action in the High Court or, as the case may be, on an order for the production of documents in an action in the Court of Session. 3 If a justice of the peace is satisfied by any written information on oath that there are reasonable grounds for entry into any premises other than premises used only as a private dwelling house for any purpose mentioned in paragraph (1), and— a admission to the premises has been or is likely to be refused and that notice of intention to apply for a warrant under this subsection has been given to the occupier; or b that an application for admission, or the giving of such notice, would defeat the object of the entry or that the premises are unoccupied or that the occupier is temporarily absent and it might defeat the object of the entry to await his return, the justice may by warrant signed by him, which shall continue in force for a period of one month, authorise any duly appointed inspector to enter the premises, if need be by force. 4 An officer entering any premises by virtue of paragraph (2) or of a warrant under paragraph (3) may take with him when he enters those premises such equipment as may appear to him necessary and any person who is authorised by the Secretary of State to accompany him on that visit. 5 On leaving any premises which an inspector is authorised to enter by a warrant under paragraph (3), that inspector shall, if the premises are unoccupied or the occupier is temporarily absent, leave the premises as effectively secured against trespassers as he found them. 6 Where, pursuant to paragraph (2)(e), an inspector takes possession of any book, document, data, record, article or substance, he shall leave on the premises with a responsible person a statement giving particulars of the book, document, record, data, article or substance sufficient to identify it and stating that he has taken possession of it. 7 Before taking possession of any substance pursuant to paragraph (2)(e), an inspector shall, where it is reasonably practicable to do so, take a sample of it pursuant to paragraph (2)(c). 8 In enforcing compliance with these Regulations, the Secretary of State or a duly appointed inspector shall have regard to any relevant provision of— a the guides for compliance monitoring procedures for good laboratory practice set out in Annex A to the GLP Inspection and Verification Directive ; and b the guidance for the conduct of laboratory inspections and study audits set out in Annex B to that Directive. Appointment of inspectors 10 1 The Secretary of State may appoint as inspectors such persons as he thinks necessary for the proper discharge of his functions under regulation 3. 2 Every appointment of a person as an inspector shall be made by notice in writing specifying or referring to the functions of the Secretary of State under regulation 3 which that person is expected to discharge. 3 An inspector shall be appointed upon such terms and conditions as the Secretary of State may determine and the Secretary of State may pay to or provide for inspectors such remuneration, benefits, allowances or reimbursement for expenses as he thinks fit. Disclosure of confidential information 11 1 A person who in the course of enforcing compliance with these Regulations gains access to commercially sensitive or other confidential information shall be guilty of an offence if without lawful authority he discloses that information. 2 A person may disclose commercially sensitive or confidential information to which he has had access in the course of enforcing compliance with these Regulations to— a the European Commission; b a monitoring authority; c a regulatory authority; d a laboratory or sponsor concerned with the inspection or study audit during the course of which that person gained access to that information. 3 For the purposes of this regulation— a the names of laboratories which are or have been subject to an inspection as part of the United Kingdom’s good laboratory practice compliance programme; b the level of adherence of a laboratory to the principles of good laboratory practice as assessed by the United Kingdom’s monitoring authority; and c the dates upon which laboratory inspections or study audits have been conducted, shall not be considered to be confidential. Obstruction etc. of inspectors 12 1 Subject to paragraph (2)— a any person who— i intentionally obstructs an inspector, or ii without reasonable cause fails to comply with any requirement made of him by an inspector, in circumstances where the inspector is acting in pursuance of any of his functions under these Regulations; or b any person who, in purported compliance with any such requirement as is mentioned in sub-paragraph (a)(ii), intentionally or recklessly furnishes information which is false or misleading in a material particular, shall be guilty of an offence. 2 Nothing in paragraph (1)(a)(ii) shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him or, in the case of a person who is married, his spouse. Offences by bodies corporate and Scottish partnerships 13 Where an offence under these Regulations is committed by a body corporate or Scottish partnership and is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of— a any director, manager, secretary, partner or similar officer of the body corporate or Scottish partnership; or b any person who was purporting to act in any such capacity, he as well as the body corporate or Scottish partnership shall be deemed to be guilty of that offence and he shall be liable to be proceeded against and punished accordingly. Defence of due diligence 14 In any proceedings for an offence under any of the preceding provisions of these Regulations, it shall be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence. Penalties 15 1 A person guilty of an offence under regulation 12(1)(a) shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale. 2 A person guilty of any other offence under these Regulations shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale or to imprisonment for not more than three months. Fees 16 1 The Secretary of State may, in respect of allaying the disbursements incurred in connection with inspecting laboratories and auditing safety studies to assess compliance with the principles of good laboratory practice, charge operators of laboratories, and operators of laboratories shall, if so charged, pay to the Secretary of State such reasonable fees as he may determine to cover the cost of carrying out such laboratory inspections and study audits. 2 The Secretary of State may set those fees at levels such that they also cover the cost of such of his overheads as are reasonably attributable to carrying out such laboratory inspections and study audits. 3 Any such fee shall be payable within fourteen days following written notice from the Secretary of State requiring payment of the fee. 4 All unpaid sums due by way of, or on account of, any fees payable under this regulation shall be recoverable as debts due to the Crown. 5 The Secretary of State may in exceptional circumstances— a waive payment of any fee or reduce any fee or part of a fee otherwise payable under this regulation; b refund the whole or part of any fee paid pursuant to this regulation. Amendment of the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 17 The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 shall be amended as follows— a in paragraph (2) of regulation 1 (citation, commencement and interpretation), after the definition of “expert” there shall be inserted the following definition— “principles of good laboratory practice” has the same meaning as in the Good Laboratory Practice Regulations 1997; ; and b in paragraph 17 of Schedule 1 (information, documents, samples and other material required in respect of applications), the words “referred to in that sub-paragraph” shall be omitted. Amendment of the Notification of New Substances Regulations 1993 18 The Notification of New Substances Regulations 1993 shall be amended as follows— a in paragraph (1) of regulation 2 (interpretation), after the definition of “preparations” there shall be inserted the following definition— “principles of good laboratory practice” has the same meaning as in the Good Laboratory Practice Regulations 1997; ; b in paragraph (b) of regulation 4 (full notifications), the words “referred to in regulation 14(1)” shall be omitted; c in paragraph (2) of regulation 5 (requirements for further testing for substances notified under regulation 4), the words “referred to in regulation 14(1)” shall be omitted; d in paragraph (1) of regulation 14 (tests under these Regulations to conform to principles of good laboratory practice), the words from “referred to in” to the end of that paragraph shall be omitted; and e paragraph (4) of regulation 14 shall be omitted. Amendment of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 19 The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 shall be amended as follows— a in paragraph (4) of regulation 1 (title, commencement and interpretation), after the definition of “the Ministers” there shall be inserted the following definition— “principles of good laboratory practice” has the same meaning as in the Good Laboratory Practice Regulations 1997; ; b in paragraph 3 of Schedule 1 (requirements in respect of products other than immunological products), the words “as referred to in the second paragraph of Part 3” shall be omitted; and c in paragraph 1 of Schedule 2 (requirements in respect of immunological products) the words from “as referred to” to the end of that paragraph shall be omitted. Department of Health Stephen Dorrell One of Her Majesty’s Principal Secretaries of State 6th March 1997 We consent, Patrick McLoughlin Richard Ottaway Two of the Lords Commissioners of Her Majesty’s Treasury 6th March 1997