Veterinary practitioners, pharmacists and farmers.
Problem Or Issue:
During the authorisation process veterinary medicines are evaluated for the safety of any residues that may remain in meat, milk, eggs and other produce that may be used for human consumption. Only those substances that have been pre-evaluated and approved as safe for consumers by the European Medicines Agency (EMA) are allowed to be used in a veterinary medicine; the HPRA sets the withdrawal period for each individual veterinary medicinal product by reference to the EMA residue benchmark (usually known as the maximum residue limit [MRL]). Where no MRL has been established for milk or eggs, the veterinary medicine cannot be authorised by the HPRA for use in cows producing milk for human consumption or for egg-laying hens. The labelling or package leaflet of the product will clearly state this.
Normally, veterinary practitioners and farmers should choose an appropriate veterinary medicine that is authorised for the species, animal type and condition being treated (e.g. use in milk-producing cows or egg-laying birds, and showing a withdrawal period for milk and eggs). Off-label use of veterinary medicines is restricted by law solely to veterinary practitioners and then only under exceptional conditions in respect of individual animals and in the interests of animal welfare. Indeed, recent scientific opinion advises particular caution in respect of off-label use of antibiotics due to concerns over antimicrobial resistance. Whichever medicine is used, off-label use carries additional risks, including a risk for consumers, and is therefore regulated by the Department of Agriculture, Food and the Marine, in accordance with the animal remedies legislation. Where a veterinary medicine without an MRL for milk or eggs must be used in milk-producing animals or egg-laying birds outside of the terms of their marketing authorisation, the veterinary practitioner must advise on the withdrawal period to be followed, which must, as a minimum, be at least 7 days for milk and eggs, but may often need to be considerably longer.