New EU regulation on veterinary medicines and animal feed

New EU regulation on veterinary medicines and animal feed

The European Veterinary Medicines Regulation is being reformed. The new EU Regulation (EU 2019/6) will enter into force for all Member States on 28 January 2022, replacing the previous Regulation (Directive 2001/82/EC). On the one hand, the new regulation aims to reduce bureaucratic hurdles and, on the other hand, to strengthen measures to combat the side effects of antibiotics.

The Regulation covers a wide range of issues in the field of medicines, from production to use. This includes, for example, measures such as:

  • a ban on the preventive or prophylactic use of antibiotics in groups of animals
  • Limiting the curative or metaphylactic use of antibiotics
  • strengthening the ban on the use of antibiotics as growth promoters
  • the possibility of allowing certain antibiotics to be used only for human consumption
  • the obligation for Member States to collect sales and usage data

Unfortunately, the risk assessment of new medicines does not yet include the risk of the formation, strengthening, spread and return of antimicrobial resistant micro-organisms back to humans. Also a possible addition effect of endocrine active substances, at least of the original substances and their main metabolites and other important transformation products, should be included in the ERA. Finally, the risks are very much projected onto the environment, while these substances (and the micro-organisms that have become resistant) return to humans via the environment (soil, food, water, air). The proposed measures should therefore be aimed at preventing this medicinal environmental cycle, e.g. with treatment specific measures (waste separation and processing).

At the same time as the new veterinary regulation is in force, the new feed regulation will also enter into force. This regulation also lays down new rules for animal feed and veterinary medicinal products.

Further information on the new EU Regulation on veterinary medicinal products and animal feed can be obtained from the European Council.