The Good Laboratory Practice Regulations 1997

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(b) membership of the programme in respect of those premises has been withdrawn from him by the Secretary of State in accordance with paragraph (3).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(c) consider any representations which are duly made and not withdrawn,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.