The Good Laboratory Practice Regulations 1999

Prospective membership of the United Kingdom good laboratory practice compliance programme U.K.

5.—(1) An operator of a test facility shall, for the purposes of these Regulations, be regarded as being a prospective member of the UK GLP compliance programme in respect of particular premises only if—

(a) he has informed the GLPMA by notice in writing of the intention to conduct regulatory studies at those premises;

(b) the GLPMA 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) An operator of a test facility shall cease to be regarded as a prospective member of the UK GLP compliance programme in respect of particular test facility premises if—

(a) he is admitted to membership of the programme in respect of those premises by the GLPMA;

(b) he informs the GLPMA in writing that he no longer conducts or intends to conduct regulatory studies at those premises; or

(c) subject 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.

(3) The GLPMA shall, before informing a prospective member of the UK GLP compliance programme they are not prepared to admit him to membership of the programme in respect of particular test facility premises—

(a) 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;

(b) give the operator a specified period within which to make representations to the GLPMA; and

(c) consider any representations which are duly made and not withdrawn,

unless, for either of the reasons set out in paragraph (4), it is necessary for the GLPMA to inform the prospective member immediately that they are not prepared to admit him to membership of the programme in respect of those premises.

(4) The reasons referred to in paragraph (3) are F1 ...—

(a) 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; F2 ...

F2 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Word in reg. 5(4) omitted (27.4.2004) by virtue of The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(b)

F2 Reg. 5(4)(b) and word omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), regs. 1, 2(a)