Good Laboratory Practice Regulations 1999

JurisdictionUK Non-devolved
CitationSI 1999/3106
  • These Regulations may be cited as the Good Laboratory Practice Regulations 1999 and shall come into force on 14th December 1999.
  • (1) In these Regulations, unless the context otherwise requires—to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number;in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; andin a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.(1) The body responsible for enforcing compliance with these Regulations shall be the Good Laboratory Practice Monitoring Authority, a body consisting of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland.(2) The functions of the Good Laboratory Practice Monitoring Authority may be performed by any one of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers or the Department of Health and Social Services for Northern Ireland acting alone, or any two or more of them acting jointly.(3) In accordance with the preceding provisions of this regulation, in these Regulations, “the Good Laboratory Practice Monitoring Authority" (“the GLPMA") means any one or more of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland, and, in the case of anything falling to be done by the GLPMA, means any one or more of them acting as mentioned in paragraph (2) .(4) The GLPMA may appoint such persons as they think necessary for the proper discharge by them of their functions, and those persons shall be appointed upon such terms and conditions (including conditions as to remuneration, benefits, allowances and reimbursement for expenses) as the GLPMA think fit.
  • the operator of the test facility 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 (hereafter referred to as “the UK GLP compliance programme") ; and
  • the operator’s membership or prospective membership of that programme is or is partly in respect of those premises,
  • he has informed the GLPMA by notice in writing of the intention to conduct regulatory studies at those premises;acknowledged receipt of that notification, andinformed the operator that he is a prospective member of the programme in respect of those premises,he is admitted to membership of the programme in respect of those premises by the GLPMA;he informs the GLPMA in writing that he no longer conducts or intends to conduct regulatory studies at those premises; orsubject to paragraph (3) , the GLPMA inform him in writing that they are not prepared to admit him to membership of the programme in respect of those premises.inform the prospective member that they are considering taking such action and explain to him in writing the reasons why such action is being considered;give the operator a specified period within which to make representations to the GLPMA; andconsider any representations which are duly made and not withdrawn,there is a failure to adhere to the principles of good laboratory practice at those premises which, in the opinion of the GLPMA, may contribute towards precipitating a danger to animal or human health or to the environment; orto ensure fulfilment of a Community obligation.he was regarded as being a member of the programme in respect of those premises immediately before these Regulations come into force by virtue of regulation 6 of the Good Laboratory Practice Regulations 1997 after having inspected those premises, the GLPMA have informed the operator in writing that they are admitting the operator to membership of the programme in respect of those premises.he has informed the GLPMA in writing that regulatory studies are no longer conducted at those premises; ormembership of the programme in respect of those premises has been withdrawn by the GLPMA in accordance with paragraph (3) .the operator, in the opinion of the GLPMA, no longer intends to conduct regulatory studies at those premises;the operator is, in the opinion of the GLPMA, not capable of ensuring that the principles of good laboratory practice are adhered to at those premises; orat those premises there is a failure to adhere to the principles of good laboratory practice which, in the opinion of the GLPMA, may contribute towards precipitating a danger to animal or human health or to the environment.

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