Search Legislation

The Good Laboratory Practice Regulations 1999

Status:

This is the original version (as it was originally made).

Prospective membership of the United Kingdom good laboratory practice compliance programme

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(c)consider any representations which are duly made and not withdrawn,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

(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; or

(b)to ensure fulfilment of a Community obligation.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources