L 52/2
EN
Official Journal of the European Union
20.2.2023
(4)
It is necessary to lay down rules supplementing the rules on disease awareness and preparedness set out in Chapter 2, Title I of Part III of Regulation (EU) 2016/429 for certain listed diseases, in particular the rules on the use of veterinary medicinal products for disease prevention and control.
Those supplementing rules and the rules set out in Regulation (EU) 2016/429 are closely linked and should be applied in tandem.
(5)
Since both terrestrial and aquatic animals may be affected by category A diseases listed in accordance with Article 5 of Regulation (EU) 2016/429, certain general rules laid down in this Regulation should cover terrestrial and aquatic animals.
This would help Member States facing an imminent risk of spread of a category A disease in their territory to immediately react under a harmonised framework, if needed.
This is particularly important for aquatic animals, since disease-specific rules for the use of vaccines against category A diseases can only be developed for terrestrial animals for the time being, due to lack of scientific knowledge, combined with lack of experience and of availability of vaccines against aquatic category A diseases.
(6)
Listed diseases referred to in Article 5 of Regulation (EU) 2016/429 which are to be controlled in all Member States with the goal of eradicating them throughout the Union (‘category B diseases’) are subject to specific rules laid down in Article 9(1), point (b), of that Regulation.
Therefore, it is necessary to harmonise the rules under which Member States may use certain veterinary medicinal products for that purpose.
Such rules should aim to ensure the effective eradication of category B diseases without detection and diagnostic interferences caused by any veterinary medicinal product.
(7)
For listed diseases referred to in Article 5 of Regulation (EU) 2016/429 which are of relevance to some Member States and for which measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed diseases concerned, as referred to in Article 9(1), point (c), of that Regulation (‘category C diseases’), rules for the use of certain veterinary medicinal products, in particular for the use of vaccines in the context of eradication programmes are laid down in Commission Delegated Regulation (EU) 2020/689 (3).
For listed diseases referred to in Article 5 of Regulation (EU) 2016/429 for which measures are needed to prevent them from spreading on account of their entry into the Union or movements between Member States, as referred to in Article 9(1), point (d), of that Regulation (‘category D diseases’), rules for the use of certain veterinary medicinal products for the movements of animals within the Union are laid down in Commission Delegated Regulation (EU) 2020/688 (4).
Such rules should therefore not be replicated in this Regulation.
(8)
In accordance with Article 46(3) of Regulation (EU) 2016/429, Member States are to take appropriate preventive measures concerning the use of veterinary medicinal products for scientific studies or for the purposes of developing and testing them under controlled conditions to protect animal and public health.
It is necessary to facilitate the research and innovation as regards development of more effective and safer veterinary medicinal products to prevent and control listed diseases.
Therefore, the rules laid down in this Regulation should not apply to the use of veterinary medicinal products for scientific studies or for the purpose of developing and testing them under controlled conditions to protect animal and public health, to avoid any unnecessary burden that may interfere in the development of new possibilities, considering the specific risk-mitigating conditions under which veterinary medicinal products are used in those circumstances.
(9)
Regulation (EU) 2019/6 of the European Parliament and of the Council (5) lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products.
That Regulation lays down a definition of a veterinary medicinal product and definitions of certain categories of veterinary medicinal products.
It also lays down conditions under which a competent authority may allow the use of an immunological veterinary medicinal product not authorised within the Union.
The rules provided for in this Regulation should comply with those definitions as well as with the requirements laid down in Regulation (EU) 2019/6, for the placing on the market, manufacturing, import,
(3) Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).
(4) Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140).
(5) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).