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Medicinal Products Act.

Type of law
Date of original text

This Act regulates the handling of medicinal products, issue of medical prescriptions, granting of marketing authorisations, clinical trials and advertising of medicinal products, and supervision over and responsibility in the field of medicinal products for the purpose of ensuring the safety, quality and efficacy of medicinal products used in Estonia and promoting the use of medicinal products for their intended purposes. A medicinal product is any substance or combination of substances intended for the prevention, diagnosis or treatment of a disease or disease symptom, for the relief of a disease condition in a human or animal, or for the restoration or alteration of vital functions in a human or animal through pharmacological, immunological or metabolic effect. The requirements in force concerning medicinal products extend to veterinary medicinal products and premixes of medicated feedingstuffs unless otherwise provided by this Act or legislation established on the basis thereof. Medicinal products must have the presumed characteristics of use and be safe for the health of the consumer when used for their intended purpose. Veterinary medicinal products must also be safe for the health of the consumer of the animal product. The list of biostimulants, hormone preparations and other substances the handling of which for the purpose of use on animals is prohibited and special circumstances under which the use of such substances is authorized for treatment of animals is established by a regulation of the minister responsible for the field. The regulation is approved by the minister responsible for the field. The conditions of and procedure for the use of medicinal products and medicated feedingstuffs for the prevention and treatment of animal disease are established by a regulation of the minister responsible for the field. Veterinarians are permitted to dispense only veterinary medicinal products from a veterinary pharmacy, but they may dispense medicinal products for human use that are used for the treatment of animals from a general pharmacy. Medicinal products subject to medical prescription, which are not veterinary medicinal products but are to be used on animals must be dispensed to veterinarians based on an order form, and to consumers based on a medical prescription issued by a veterinarian. Medicinal products dispensed for veterinary use must be marked with the words Ainult veterinaarseks kasutamiseks [for veterinary use only]. The Act further provides for storage and transport of medicinal products and handling of medicinal products withdrawn from market; handling and brokering authorisation; registration of pharmacists and assistant pharmacists and recognition of professional qualifications of pharmacists; marketing authorisation of medicinal product; advertising medicinal products and inducement designed to promote sales and prescription; and clinical trials of medicinal products.
Date of consolidation/reprint
Serial Imprint
RT I 2005, 2, 4
Source language


Legislation Amendment
Original title