Government Decree No. HG311/2012 validating the Regulation establishing the regulatory conditions for the preparation, introduction to the market and use of medicinal feed.

This Government Decree regulates conditions for the preparation, introduction to the market and use of medicinal feed. National Agency for Food Safety authorizes premixes for medicinal feed to be placed on the market after their registration in the State Register of Veterinary Medicines. Medicinal feeds must be produced only with registered premixes for medicinal feed. Manufactured medicinal feed shall be subject to regular testing, including appropriate laboratory tests for uniformity - on the part of producing farms, in order to ensure compliance of medicinal feed with the requirements of this Regulation, especially as regards their homogeneity, sustainability, stability and storage periods. Manufacturers are required to keep daily records of the types and quantities of premixes and feed products used, as well as those produced, held by them or sent medicinal feed, together with the names and addresses of livestock breeders or owners of animals and, if necessary, the name and address of the authorized distributor, name and address of the veterinarian who issued the prescription. Premixes for medicinal feeds and medicinal feed should be stored in separate safe premises or in sealed containers, specially intended for storing such products. The manufacturer shall be responsible for: (a) using only feed products or their combinations that comply with feed requirements; (b) obtaining from the feed product and medicinal premix used, a homogeneous and stable mixture; (c) the premix is used during the manufacturing process in accordance with established conditions upon registration, in particular: between veterinary medicinal products, additives and feed products there is no unwanted interaction; medicinal feed is stored until the expiration date; feedstuffs used for the preparation of medicinal feed, must not contain the same antibiotic or coccidiostatic agent that is used as an active substance in a premix for medicinal feed; and (d) the daily dose content of the drug must be in the volume of the feed product, corresponding to at least half of the animals' daily feed ration, for animals being treated, or in the case of ruminants, corresponds to at least half the daily requirement for non-mineral supplementary feed products. The Agency stipulates that medicinal feed may only be placed on the market in a package or container sealed in such a way that when the package is opened the seal is damaged and it is impossible to use it.