TITLE IIIREFERENCE LABORATORIES AND REFERENCE CENTRES

Article 100Designation of national reference laboratories

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The appropriate authority must designate one or more laboratories to act as national reference laboratories for Great Britain, in such of those areas governed by the rules referred to in Article 1(2) as the appropriate authority considers appropriate.

1A.

F5The national reference laboratories designated in accordance with paragraph 1 may—

be situated in the United Kingdom, or in another country;

be designated in relation to more than one area of the rules referred to in Article 1(2);

apply in relation to areas of those rules falling within the responsibilities of more than one competent authority.

1B.

Where the appropriate authority considers it appropriate, the power to designate a laboratory as a national reference laboratory in accordance with paragraph 1 may be exercised by a competent authority.

2

The requirements provided for in point (e) of Article 37(4), Article 37(5), Article 39 and Article 42(1), points (a) and (b) of Article 42(2) and Article 42(3) shall apply to national reference laboratories.

By way of derogation from point (e) of Article 37(4), for the area governed by the rules referred to in point (g) of Article 1(2), F3the appropriate authority or, in a case where the power to designate has been delegated to a competent authority in accordance with paragraph 1B, a competent authority, may designate as a national reference laboratory an official laboratory designated as such in accordance with regulations made under Article 41, irrespective of whether it fulfils the condition provided for in point (e) of Article 37(4).

3

National reference laboratories shall:

a

be impartial, free from any conflict of interests, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as national reference laboratories;

b

have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence, and support staff as appropriate;

c

possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them;

d

ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at nationalF2... and international level are taken into account in their work;

e

be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and

f

where relevant, be equipped to comply with relevant biosecurity standards.

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The appropriate authority, or, in a case where the power to designate has been delegated to the competent authority, the competent authority, must—

a

publish online the name and address of each national reference laboratory designated in accordance with paragraph 1; and

b

ensure that the information published in accordance with point (a) is kept up to date.

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