of November 17, 2014 No. 203-Z
About modification and amendments in the Law of the Republic of Belarus "About medicines"
Accepted by the House of Representatives on October 22, 2014
Approved by Council of the Republic on October 31, 2014
Article 1. Bring in the Law of the Republic of Belarus of July 20, 2006 "About medicines" (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258; 2009, No. 148, 2/1579; 2012, No. 1, 2/1878) following changes and amendments:
1. State Article 1 in the following edition:
"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 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;
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