European regulations on prevention use of antimicrobials from january 2022.

Over the past several years significant progress on achieving better antibiotic stewardship in the veterinary sector has been achieved through regulatory legislations both in the USA and the European Union, including the implementation of US FDA GL 209 and 213. The EU is now taking measures to phase out the routine use of antibiotics for disease prevention, reserving prophylactic use for exceptional circumstances. This article intends to add some clarifications regarding antibiotics for disease prevention that are embedded in two EU regulations which came into force on 28th January 2022, Regulation (EU) 2019/4 on Medicated Feed and Regulation (EU) 2019/6 on Veterinary Medicinal Products.

Ao longo dos últimos anos, progressos significativos na obtenção de uma melhor administração de antibióticos no setor veterinário foram alcançados por meio de legislações regulatórias nos EUA e na União Européia, incluindo a implementação do FDA GL 209 e 213 dos EUA. o uso rotineiro de antibióticos para prevenção de doenças, reservando o uso profilático para circunstâncias excepcionais. Este artigo pretende adicionar alguns esclarecimentos sobre antibióticos para prevenção de doenças que estão inseridos em dois regulamentos da UE que entraram em vigor em 28 de janeiro de 2022, Regulamento (UE) 2019/4 sobre alimentos medicamentosos para animais e Regulamento (UE) 2019/6 sobre medicamentos veterinários.

Can we align antibiotic policies at an international level in the absence of harmonized definitions?

The foundations of robust policies are reliant on harmonized definitions allowing consistency of understanding. However, it is evident that there is a lack of harmonization of definitions in the antibiotic space and even the simplest of terms such as 'antibiotic' and 'antimicrobial' do not have a single harmonized definition at an international level. This lack of harmonization makes interpretation of policies in different geographies a difficult, sometimes impossible, task. This article proposes a set of definitions that could be adopted by international institutions such as the WHO, World Organisation for Animal Health (OIE) and Food and Agriculture Organisation (FAO) as well as regulatory agencies.