Governmental Decree No. HG696/2020 validating the Requirements for the equipment and operation of facilities authorized to possess, distribute and dispense veterinary medicinal products.

Requirements for the equipment and operation of facilities authorized to possess, distribute and dispense veterinary medicinal products regulate the sanitary and veterinary conditions for the organization, functioning, equipment and operation of pharmaceutical veterinary warehouses, veterinary pharmacies and professional animal breeding facilities. Pharmaceutical veterinary unit shall be intended any establishment for the manufacturing, import, storage, wholesale and retail distribution of veterinary drugs, reagents, veterinary diagnostic kits and other veterinary preparations. Medicinal products for veterinary use throughout the distribution chain must be stored in accordance with the requirements indicated on the label and in the leaflet inserted in the package. The National Agency for Food Safety prescribes the withdrawal and placement in the quarantine zone within the pharmaceutical veterinary unit subject to control of veterinary medicines that are not registered in the State Register of Veterinary Medicines, which are counterfeit, repackaged without permission, damaged, expired, unmarked or without an inserted leaflet. Withdrawal is carried out on the basis of the protocol, a sample of which is given in Appendix No. 2. In pharmaceutical veterinary units it is prohibited: (a) carrying out activities other than those provided for in the veterinary and sanitary authorization; (b) distribution and sale of veterinary medicinal products via the Internet; (c) possession and trade in animals and birds; and (d) smoking, eating in the premises used for the production, storage and handling of veterinary medicinal products, reagents and veterinary diagnostic kits. It is forbidden to place a pharmaceutical veterinary warehouse inside residential buildings. Access by unauthorized persons to storage facilities for veterinary medicines is prohibited. An inventory of stocks of veterinary medicines is carried out at least once a year, by comparing the number of manufactured/imported and sold veterinary medicines with the actual number of veterinary medicines per stock. The following documents shall be kept at the pharmaceutical veterinary warehouse and submitted to the Agency upon request: (a) the original veterinary and sanitary authorization for the activity; (b) copies of registration certificates for veterinary drugs; and (c) copies of documents confirming the origin and quality (compliance) of veterinary drugs.