Law no. 10 of 2006 concerning Veterinary Medicinal Products (Quality Control, Registration, Circulation, Manufacture, Administration and Use).

This Law, consisting of 106 articles and divided into nine Parts, in harmonisation with the Directive 2001/82/EC of the European Parliament and of the Council on veterinary medicinal products, applies to: preparation of veterinary medicinal products, including premixes for medicated animal feed, active substances used as raw materials, specific substances that may be used as veterinary medicinal products with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties, except for: inactivated or non-inactivated immunological veterinary medicinal products prepared from pathogens and antigens from an animal of a livestock and used for the treatment of the same animal, veterinary medicinal products based on radioactive isotopes. The following relevant terms are defined: adverse effects; adverse reaction in human; immunological veterinary medicinal product; galenic medicinal product; over-the-counter galenic medicinal product; dosage of veterinary medicinal product; registered; outer packaging; labelling; risks associated with the use of the product, including any risk of adverse effects on the environment and risks for human and animal health; veterinary prescription; veterinary medicinal product; distribute; retail sale; unintended use; homeopathic veterinary medicinal product; substance; manufacture of active substances used as raw materials; mixture for medicated animal feed; feed additive; serious adverse reaction; benefit/risk ratio; wholesale of veterinary medicinal products.
This Law provides for: the establishment of a Veterinary Medicinal Products Council, its duties and obligations, including issuing and revoking of licenses. According to the Law, the availability of a veterinary medicinal product is subject to a marketing authorisation from the Council for Veterinary Medicinal Products, except for products for companion animals, such as rodents, aquarium fishes, songbirds, homing pigeons, animals kept in terrariums. The Law defines procedures for the issuance of an authorisation and specific requirements for marketing authorisation of a veterinary medicinal product administered to food-producing animals; specifies characteristic of a veterinary medicinal product; details obligations of marketing authorisation holder; concerns protection and use of industrial and commercial intellectual property rights. Matters covered by this Law concern: manufacture and importation of veterinary medicinal products and related measures; definition of qualified person and its obligations; administrative measures; inspection and controls of immunological veterinary medicinal products; advertising of veterinary medicinal products, including type and content of advertising directed at the public; prescription and possession of veterinary medicinal products and compliance with the European legislation and the following international conventions: Single Convention on Narcotic Drugs (Sanctions) Act of 1969, the Protocol to Amend the Single Convention on Narcotic Drugs (Sanctions) Act of 1973, the Convention on Psychotropic Substances (Sanctions) Act of 1973 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (Sanctions) Act 1990; dispensing of veterinary medicinal products, including: keeping a record of treated animals, administration of a veterinary medicinal product to a food-producing animal and specification of waiting times for different animal products.