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CHAPTER VIU.K.LABORATORIES

Article 11U.K.Reference laboratories

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3.[F3The appropriate authority may] designate F4... reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1. F5...

[F64.The appropriate authority may, by regulations, make provision regarding—

(a)the responsibilities and tasks of reference laboratories;

(b)coordination between reference laboratories and laboratories designated under Article 12(1)(a).]

Article 12U.K.Approval of laboratories, quality requirements and approved testing methods

1.Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:

(a)be designated by the competent authority; and

(b)apply quality assurance systems that conform to the requirements of the current [F7ISO] standard at the latest F8... within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.

2.Laboratories shall regularly participate in collaborative testing organised or coordinated by the F9... reference laboratory.

3.[F10Subject to paragraph 4,] testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

Alternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.

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[F124.Where in the opinion of the appropriate authority it is necessary to do so, the appropriate authority may, by regulations, approve other methods for testing.]