LAW OF THE REPUBLIC OF MOLDOVA

of December 17, 1997 No. 1409-XIII

About drugs

The parliament adopts this law.

Chapter I General provisions

Article 1. Purpose and scope of this law

(1) the Purpose of this law is providing at the national level of access of the population through system of supply with medicines to high-quality, effective and harmless drugs with preserving reasonable prices for them, non-admission of uncontrolled application of drugs.

(2) This law is applied in all fields of activity having as medicine object: their research, registration, production, implementation in practice, application, import, export, storage, distribution, leave, control.

(3) Operation of this law does not extend to nutritional supplements, substances for external application in the cosmetic purposes, on dietary and nutritious components for animals (vitamins, mineral substances, etc.). The Ministry of Health has the right to bring the above-named substances under operation of this law if they have some biologically active properties or have side effect on human body.

(4) the Ministry of Health has the right to resolve partial or complete application of this law concerning one substance or group of the substances which are not drugs, but having similar it effect if it is required from the point of view of health of the person or rendering medical care to it.

(5) Provisions of this law do not contradict legislation provisions which concern the drugs and medicines which are doping agents.

Article 2. Legislation on drugs

The legislation on drugs consists of this law, the Law on pharmaceutical activities, the Law on turnover of narcotic, psychotropic substances and precursors, the Law on veterinary activities and other regulations regulating activities in the field of drugs.

Article 3. Basic concepts

In this law the following basic concepts are used:

drugs (medicines and medicines) - substances or mixes of substances permitted in accordance with the established procedure to production, import, export and use for treatment, simplification of condition, prevention and diagnosis of diseases, abnormal physical or mental condition or their symptoms at the person or animal and also for recovery, korrigirovaniye and modification of their organic functions;

medicinal substance (active) - biologically active agent of natural, synthetic or biotechnological origin used for production or preparation of drugs;

radioactive medicine - medicine which action is based on use of radiation ionizing radiation (sources of radiation are not considered as radioactive medicines);

preclinical research of medicine - carrying out physical and chemical, pharmaceutical, biological, microbiological, pharmacological, physiopathological, toxicological and other researches of medicine in vitro;

clinical trial of medicine - studying of effect of the medicine on human body for the purpose of confirmation of its efficiency and safety, and also ensuring its correct application;

the unlicensed international name (UIN) - the name used in official regulations for medicines. These names cannot be registered as original;

counterfeited medicine - medicine which has the false marking intentionally distorting it authenticity and/or its origin that is shown in misstatement of both trade names, and the international non-proprietary name and which may contain necessary ingredients, other ingredients or not to contain active agents, or to contain them in insufficient quantity or to have deceptive package.

the registration certificate of medicine (further - SRL) - the official document by which registration of medicine by the Agency on drugs and medical products after approval of medicine is confirmed;

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