Public consultation on reflection paper on prophylactic use of antimicrobials in animals

EMA has published a draft reflection paper on the prophylactic use of antimicrobials in animals for public consultation. Comments can be provided until 29 April 2022.

Promoting the responsible use of antimicrobials in animals is one of the main aims of the Veterinary Medicinal Products Regulation that became applicable in the European Union (EU) on 28 January 2022. Amongst the measures introduced by the Regulation to fight antimicrobial resistance are restrictions on the prophylactic use of antimicrobial medicines in animals. In such circumstances, antimicrobials may now only be used in exceptional cases, in an individual or a restricted number of animals, when the risk of infection is very high and the consequences are likely to be severe. For antibiotics specifically, prophylaxis is limited to an individual animal.

The purpose of the reflection paper is to establish an understanding of the term ‘prophylaxis’ as stated in the Regulation, where it is defined as “the administration of a medicinal product to an animal or group of animals before clinical signs of a disease, in order to prevent the occurrence of disease or infection” [Article 4(16)]. The reflection paper also intends to develop high-level principles to guide the implementation of the restrictions on the prophylactic use of antimicrobial medicinal products in animals [Article 107(3)].