The Good Laboratory Practice Regulations 1997

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(c) consider any representations which are duly made and not withdrawn,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.