Law “On Livestock and Animal Drugs and Feed Additives”.

The scope of this Law is to regulate the licensing, registration, production, certification, trade, supply, use, and control of veterinary drugs, medical devices, biological products, disinfectants, feed additives, and diagnostic products. The following principles shall be followed regarding animal drugs and feed additives: (a) increase transparency, openness, and accountability in the pharmaceutical industry and strengthen a comprehensive drug regulatory system; (b) provide accessible and sustainable access to medicines and medical supplies; (c) conduct pharmaceutical industry activities based on research and evidence and determine development trends in an efficient manner; (d) sustainably provide the pharmaceutical industry with qualified and skilled human resources; (e) introduce good practices in pharmaceutical supply organizations; and (f) support the national production of medicines, medical devices, and nutritional supplements. The non-permanent Veterinary Medicine Council and the Pharmacopoeia Committee shall operate under the state administrative body responsible for animal health issues, with the responsibility of supporting the implementation of the state's policies on medicines, biopreparations, sterilization and disinfection preparations, pharmaceutical raw materials, and feed additives. The Council shall exercise the following powers: (a) register, amend, and deregister medicines, biological products, sterilization and disinfection preparations, pharmaceutical raw materials, and feed additives; (b) discuss and decide on the results of clinical trials and tests of newly developed drugs, biopreparations, sterilization and disinfection preparations, pharmaceutical raw materials, and nutritional supplements; (c) develop proposals and recommendations on the selection of drugs, biological preparations, sterilization and disinfection preparations, and nutritional supplements for prevention, diagnosis, and treatment; (d) discuss whether clinical trials are required for drugs, biologics, and sterilization and disinfection products imported and registered in Mongolia for the first time; (e) develop proposals and recommendations on government policy issues regarding medicines, biopreparations, sterilization and disinfection preparations, pharmaceutical raw materials, and nutritional supplements, and submit them to the relevant central government administrative organization; (f) discuss the annual report of the licensed supply organization, issue conclusions and recommendations; and (g) issue professional recommendations on drug warnings, safety, and potential risks. The following drugs, biological preparations, disinfectants, pharmaceutical raw materials, and feed additives shall be subject to mandatory registration: (a) all types of preventive, diagnostic, and therapeutic drugs, biological preparations, sterilization and disinfection preparations, pharmaceutical raw materials, and nutritional additives; (b) medicines, biological preparations, sterilization and disinfection preparations, pharmaceutical raw materials, and nutritional additives with changes in dosage, form, packaging, composition, instructions for use, and production technology; (c) international loans, aid, and donations of medicines, biological products, sterilization and disinfection products, pharmaceutical raw materials, and feed additives; and (d) industrially prepared therapeutic doses of vitamins and drugs intended to support and prevent treatment. The containers, packaging, labels, and markings of medicines, biological products, sterilization and disinfection preparations, pharmaceutical raw materials, and nutritional additives shall contain the following information: (a) commercial and international names; (b) form; (c) composition, dosage, size, quantity; (d) name of the manufacturer; (e) serial number; (f) method of application; (g) date of manufacture and expiration date; (h) registration number; and (i) pharmacopoeia article number. Newly developed drugs, biopreparations, sterilization and disinfection preparations, pharmaceutical raw materials, nutritional additives, and diagnostics shall be verified by the results of pharmacological, pharmacology, toxicology, and other studies.