SOPs

Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’) and its supplementing legislation becomes applicable on 21 April 2021.

Following the provisions of Article 6 of Commission Delegated Regulation (EU) 2020/689 supplementing Regulation (EU) 2016/429 as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases, we move to a system where the competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods complies with:

1. The specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the websites of the European Union Reference Laboratories (EURL) and of the Commission;
2. If not covered by the first indent, the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals or the Manual of Diagnostic Tests for Aquatic Animals of the World Organisation for Animal Health (OIE);
3. If not covered by either of the two previous indents, with the methods laid down in paragraphs 2(b) and 3 of Article 34 of Regulation (EU) 2017/6253.

The above cascade indicates the intention to primarily rely on the relevant details and guidance made available on the websites of the European Union Reference Laboratories as regards collection of samples, techniques, validation and interpretation of diagnostic methods

Please note, that whenever the information concerning the collection of samples, the techniques, validation and interpretation of the diagnostic methods is not available in the EURLs website, then the relevant information laid down in the OIE Manuals is considered applicable and adequate.

NRLs can use the diagnostic methods used by the EURL or similar methods described in the OIE manual or equivalent fully validated methods used by the NRL in the annual PT. Below the procedures as applied by the EURL for collection of samples, diagnostic techniques and validation of diagnostic methods are available.