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LAW OF THE REPUBLIC OF BELARUS

of July 20, 2006 No. 161-Z

About medicines

(The last edition from 29-06-2016)

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 and (or) realization of medicines 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 or the individual entrepreneur registered in the Republic of Belarus, to the foreign legal entity and 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 other is not determined by this Law, – legal entities and individual entrepreneurs) having special permission (license) for implementation of pharmaceutical activities;

safety of medicine – the positive characteristic of medicine based on the comparative analysis of its efficiency and risk assessment of damnification of life and to health of the person;

biologically similar medicine (bioanalogue) – the biological medicine similar on safety, efficiency and quality to original medicine in the same dosage form;

biological medicine – the medicine received or emitted from biological source, and also synthesized by biotechnology methods;

biotechnological medicine – the biological medicine made by bioengineering procedures using technology of recombinant deoxyribonucleic acid, technology of controlled expression of the genes coding development of biologically active proteins, methods of hybridization and monoclonal antibodies and other bioengineering procedures;

excipient – the substance or combination of several substances which do not have pharmacological activity and used in the course of industrial production, pharmaceutical production of medicine for giving of certain dosage form to it;

generic medicine – the medicine containing the same pharmaceutical substance or combination of pharmaceutical substances in the same dosage form, as the original medicine equivalent to original medicine and therapeutic interchanged with it;

homeopathic medicine – the medicine made or made on special technology of homeopathic raw materials;

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 the admission to industrial production, realization and medical application of the medicine made in the Republic of Belarus and also to realization and medical application of the medicine arriving because of its limits;

the applicant – the legal entity of the Republic of Belarus or the individual entrepreneur registered in the Republic of Belarus, the foreign legal entity, the foreign organization created according to the legislation of foreign states, making medicines or placing the order for industrial production of medicines in other organization performing industrial production of medicines, or associations which are part which is also producer of medicines;

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