PART IGENERAL PROVISIONS

Article 3Clinical examinations, sampling procedures and diagnostic methods

1

Where clinical examinations of animals are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that:

a

the sampling of animals for clinical examination is carried out in accordance with:

  1. (i)

    point A.1 of Annex I for terrestrial animals; and

  2. (ii)

    point 1 of Annex XII for aquatic animals;

b

the clinical examination comprises:

  1. (i)

    an initial general evaluation of the animal health status of the establishment which comprises all the animals of listed species kept in the establishment; and

  2. (ii)

    an individual examination of the animals included in the sample referred to in point (a).

2

Where laboratory examinations are required pursuant to this Regulation in order to confirm or rule out the presence of a category A disease, the competent authority shall ensure that:

a

the sampling of animals for laboratory examination is carried out in accordance with:

  1. (i)

    point A.2 of Annex I for terrestrial animals; and

  2. (ii)

    point 1(b), (c), (d) and (e) of Annex XII for aquatic animals;

b

the diagnostic methods for laboratory examinations fulfil the requirements set out in:

  1. (i)

    point B of Annex I for terrestrial animals; and

  2. (ii)

    point 2 of Annex XII for aquatic animals;

c

the samples are sent:

  1. (i)

    without delay to an official laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the Council13;

  2. (ii)

    in accordance with point C of Annex I for terrestrial animals and point 1(f) of Annex XII for aquatic animals; and

  3. (iii)

    following any other instruction from the competent authority and from the laboratory regarding biosecurity and biosafety conditions to prevent the spread of category A disease agents;

d

in the case of kept animals:

  1. (i)

    an inventory of all kept animals on the establishment and their species and categories is compiled; for poultry and aquaculture animals the number of animals may be estimated; and

  2. (ii)

    an identification mark of each sampled animal of listed species, or in the case of poultry and aquaculture animals the batch number, is recorded.