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LAW OF THE REPUBLIC OF BELARUS

of July 20, 2006 No. 161-Z

About drug circulation

(as amended on 13-05-2020)

Accepted by the House of Representatives on June 23, 2006

Approved by Council of the Republic on June 30, 2006

This Law is directed to enhancement of legal and organizational basis of state regulation in the sphere of drug circulation for the purpose of providing the population of the Republic of Belarus with safe, effective and high-quality medicines.

Chapter 1. General provisions
Article 1. The main terms used in this Law and their determinations

For the purposes of this Law the following main terms and their determinations are used:

antiseptic medicine - the medicine having antimicrobic, antiviral, antiparasitic, antifungal action and used mainly for external application for the purpose of medical prevention and treatment of infectious diseases;

drugstore - the complex of specialized rooms (the specialized room) and the equipment intended for pharmaceutical production, realization, leave of medicines, medical products and other goods of pharmaceutical assortment and belonging on the property right or on other legal cause to the legal entity of the Republic of Belarus, the individual entrepreneur registered in the Republic of Belarus, to the foreign legal entity, the foreign organization created according to the legislation of foreign states in the presence of the representation opened in accordance with the established procedure in the territory of the Republic of Belarus (further, if is not established other, - legal entities and individual entrepreneurs) having special permission (license) for implementation of pharmaceutical activities;

safety of medicine - the characteristic of medicine based on the sufficient evidential base confirming lack of the unacceptable risk connected with possibility of damnification and (or) drawing damage to health of the person in case of observance of requirements for medical application, transportation, storage;

excipient - substance, except for pharmaceutical substances (active pharmaceutical substances) (further - pharmaceutical substances), being part of medicine for giving of necessary properties to it;

state registration of medicine - the procedure of recognition of compliance of medicine to requirements for safety, efficiency and quality imposed to it performed for the purpose of its admission to realization and medical application in the territory of the Republic of Belarus;

The state register of medicines of the Republic of Belarus - the state information resource containing data on the medicines registered in the Republic of Belarus;

the holder of the registration certificate - the legal entity of the Republic of Belarus, the individual entrepreneur registered in the Republic of Belarus, the foreign legal entity, the foreign organization created according to the legislation of foreign states to which the registration certificate is issued and which bear responsibility for safety, efficiency and quality of medicine;

preclinical (not clinical) research of medicine - chemical, physical, biological, microbiological, pharmacological, toxicological or other pilot study or series of researches on studying of medicine by application of scientific methods of estimates for the purpose of studying of its specific action and (or) proofs of safety for health of the person;

inspection (pharmaceutical inspection) - assessment of stage (process) of drug circulation for the purpose of establishment of its compliance to requirements proper pharmaceutical the practician in the sphere of drug circulation;

the instruction on medical application (leaf insert) - the document placed in packaging with medicine, containing information for the consumer;

the researched medicine - medicine which when performing clinical trial (testing) is subjected to test or is applied to comparison including placebo, including the registered medicine if the method of its application differs from approved and also if it is used according to the new indication for medical application or receipt of the additional information according to the approved indication;

quality of medicine - the set of properties and characteristics of pharmaceutical substance, medicine providing their compliance to purpose for medical application;

clinical trial (testing) of medicine - studying of diagnostic, medicinal, preventive, pharmacological properties of medicine in the course of its medical application the subject of research, including processes of absorption, distribution, metabolism and removal, by application of scientific methods of estimates for the purpose of the receipt of proofs of safety and efficiency of medicine this about undesirable reactions of human body to medical application of medicine and about effect of its interaction with other medicines and (or) foodstuff;

dosage form - the medicine condition corresponding to methods of its introduction and medical application and providing achievement of necessary effect;

medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, medical prevention of diseases of the person or recovery, correction or change of physiological functions of its organism by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and conditions of the person;

medicine - medicine in the form of dosage form;

undesirable reaction - the inadvertent adverse reaction of human body connected using medicine or the researched medicine and assuming availability of possible interrelation using such medicines;

unforeseen undesirable reaction - undesirable reaction, nature, severity or outcome of which do not correspond to information containing in general characteristic of medicine or the brochure of the researcher for the researched medicine;

the regulating document on quality - the document of the producer of medicine establishing requirements to medicine quality control, containing indicators of quality and the description of the methods and analytical techniques used in case of medicine quality control;

drug circulation - development, preclinical (not clinical) researches, clinical trials (testing), examination, inspection (pharmaceutical inspection), registration, pharmakonadzor, quality control, industrial production, pharmaceutical production, storage, transportation, import, export, realization, leave, medical application, return to the producer or supplier, destruction of medicines;

general characteristic of medicine - the document containing information for health and pharmaceutical workers on safe and effective medical application of medicine, placed in the State register of medicines of the Republic of Belarus and (or) the unified register of the registered medicines of the Eurasian Economic Union;

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