Legal status regarding distribution/dispensing and administration of veterinary medicines in Republic of Macedonia

Abstract

INTRODUCTION Animal medicines play an important role in the control and prevention of disease but have the potential to cause harm if not used properly. The use of veterinary medicines (VM) can sometimes result in residues in foods taken from the treated animals and can seriously endangered the health of people as potential consumers. Therefore, the significance of control of the VM in these animals is exceptionally high. These include statutory controls on the authorisation, distribution and use of such medicines. The aim of this paper is to show legal status regarding distribution/dispensing and administration of VM in Macedonia (RM) in order to identify legal weaknesses. MATERIALS AND METHODS National Law on VM (Article 47) provides legal basis for distribution of VM in categories. Following evaluation of scientific data provided by the MAH, for each VM is granted a specific distribution category by the Food and Veterinary Agency (FVA) when it is for first time authorised. The data was collected from the web site of sector for Public Health in FVA and was compared with Veterinary Medicines Regulations in other countries. RESULTS All VM in the RM are assigned into one of six distribution categories. Only veterinary surgeons (VS) are entitled to prescribe VM and they must be dispensed from registered premises. The highest level of control is the VM intended for food production animals which can be used only in veterinary premisses by the VS or under their direct responsibility. This would include VM containing controlled drugs and those intended for administration only following a diagnosis and clinical assessment of the animal(s). VM which can be dispensed in veterinary pharmacies only by written prescription is intended for food production animals but is not required a clinical assessment. VM intended for non-food production animals may be supplied by any retailer without any restrictions, or provision of advice.CONCLUSIONS Distribution categories provide controls on the supply of veterinary medicines to help ensure that appropriate advice is given at the point of sale so that products can be used safely and effectively. Also it is a practical tool for identification of different groups of VM for the veterinary practitioners as well as all subjects involved in production, trade and distribution of VM. The results obtained given an overall picture of trends in the use of VM in RM and allows comparison of such trends in other countries.