Law No. 119 “On veterinary drugs”.

This Law establishes the conditions and procedure for the registration, manufacturing, import, export, storage, distribution and delivery of veterinary medicinal products for the purpose of supply thereof to the national market. This Law consists of VIII Sections. Section I lays down general provisions. Section II establishes the provisions for registration of veterinary drugs. Section III regards import and export. Section IV establishes the provisions for packaging and labelling. Section V deals with ownership, distribution and trade of veterinary drugs. Section VI deals with pharmaceutical supervision. Section VII regards enforcement and penalties. Section VIII lays down final and transitional provisions. Veterinary medicinal product shall be intended: (a) any substance or combination of substances intended for the treatment or prevention of animal diseases; or (b) any substance or combination of substances that can be used or applied to animals for the purpose of restoring, adjusting or altering physiological functions by pharmacological, immunological or metabolic effects, or for the purpose of establishing a medical diagnosis. The provisions of this Law shall not apply to: (a) medicinal feedstuffs; (b) veterinary medicinal products intended for the research and implementation of clinical tests; (c) feed additives; (d) inactivated immunological veterinary medicinal products derived from pathogenic agents and antigens obtained from animals or animals from the same farm and used to treat animals or animals from the same farm in the same locality; and (e) veterinary medicinal products based on radioactive isotopes. Trade of medicinal products (veterinary drugs) shall be authorized in the presence of registration certificate. Applicant for registration of veterinary drugs can be exclusively the holder of veterinary and sanitary authorization for manufacturing of import thereof. The procedure for issuance of registration certificate for veterinary drugs shall be performed within 210 calendar days from the date of submittal of the application for registration of veterinary drugs. The application for a certificate of registration must include all necessary administrative information and scientific documentation proving the quality, safety and efficacy of a veterinary drug. Secondary packaging of registered veterinary drugs must contain the following information: (a) name of veterinary drug, its concentration and pharmaceutical form; (b) list of active substances expressed qualitatively and quantitatively for a single dose; (c) batch number/production series; (c) attributed registration number; (d) company name, the address of the holder of registration certificate; (d) animal species for which veterinary drug is intended for application, application method and prescribed dose; (e) waiting period for livestock and products of animal origin; (f) special precautionary measures; (g) manufacturing date and expiry date; (h) special storage conditions, if required; and (i) inscription “For veterinary use only”.