benefit-risk balance
as defined in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11…, Article 4, point (19) (Definitions)
an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product: (a) any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; (b) any risk of undesirable effects on the environment; (c) any risk relating to the development of resistance;