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.