A new regulation governing veterinary medicinal products has been formally published in the official journal of the EU. The chief aim of the regulation is to reduce antibiotic use in food producing animals (in particular preventative antibiotic use) in order to address the public health risk of antimicrobial resistance. The regulation (replacing Directive 2001/82/EC) has been under discussion for nearly 4.5 years. It harmonises the authorisation, distribution and pharmacovigilance systems for veterinary medicines across the EU.
The Regulation includes the following provisions:
- Antibiotics must not be applied routinely
- Antibiotics must not be used to compensate for poor hygiene
- Antibiotics must not compensate for inadequate animal husbandry
- Antibiotics must not compensate for poor farm management
- Antibiotics cannot be used for prophylaxis treatment (preventative treatment to healthy animals) except in exceptional circumstances.
- Antibiotic used for metaphylaxis treatment only when the risk of spread of an infection or of an infectious disease in the group of animals is high and where no other appropriate alternatives are available.
- Restriction of use of certain types of antibiotics (CIAs)
- Veterinary prescription based on clinical examination or other proper assessment
- Veterinary prescriptions only valid for 5 days
- Veterinary prescriptions limited to the amount required for the treatment concerned
As the regulation was published in the Official Journal of the EU on 7th January 2019. It will come into force three years following this (i.e. January 2022).
In relation to the preventative use of antibiotics on dairy farms, DAFM informed a recent meeting of the AHI CellCheck Implementation Group that while the legislation will not mean an absolute ban on blanket dry cow treatment after January 2022, there will be “strict restrictions” and a significant increase in milk recording levels will be required.
The Department will now have to prepare an implementing act in 2019, and will be consulting with stakeholders including ICOS as part of this process. They are also planning public information meetings or “road shows” to create greater awareness within the farming community.
A more detailed circular on the implications of the regulation is available by contacting Eamonn Farrell at firstname.lastname@example.org
Agri-Food Policy Executive
17 Jan 2019
19 Dec 2018