The Law of the KR «On making amendments and changes to certain legislative acts of the KR» 4 th MeTA Forum in the Kyrgyz Republic Bishkek, December 8, 2015

Content 1.General characteristics of the legislation on circulation of drugs and medical products 2.Harmonization of provisions of legislative bills with the legislative acts of other branches of law, elimination of gaps

General characteristics of the legislation on circulation of drugs and medical products Modernization, dynamic development of the health care system Accession of the KR to EEU Modernization, dynamic development of the health care system Accession of the KR to EEU The gap between the needs of the health care system and its regulatory framework The gap between the needs of the health care system and its regulatory framework The basis for the development of draft laws

2. The harmonization of the provisions, the elimination of gaps and increasing the responsibility Special laws (The laws of the Kyrgyz Republic: on health care for citizens of the KR, on advertisements, on licensing system in the Kyrgyz Republic, etc.) Legislative acts of other branches of law (The Code of the Kyrgyz Republic on Administrative Liability, the Criminal Code of the Kyrgyz Republic)

The Code of the Kyrgyz Republic on Administrative Liability Current edition Article 93. Violation of the rules on production, procurement and sale of medicines, diagnostic, preventive and therapeutic cosmetics, goods and medical equipment, therapeutic and preventive products and food additives Proposed edition Article 93. Violation of the rules of good pharmacy practices and the rules of the registration, the confirmation of registration, pharmaceutical inspection, the importation, the transportation, the storage, the labeling, the sale and the advertising of drugs, medical products and dietary supplements

The Code of the Kyrgyz Republic on Administrative Liability Current edition Article 302. Trading in undesignated places - Street trading of all kinds of goods and products from the stalls and vehicles in undesignated places - Trading of fuels and lubricants in undesignated places reas Amended edition Article 302 to be added with a new paragraph as follows: "Retail street trading of drugs, medical products and dietary supplements from the stalls and vehicles in undesignated places

The Code of the Kyrgyz Republic on Administrative Liability Current edition No regulation Amended edition Article (new rule) Failure by the heads of local state administrations and local authorities in their respective territories and by officials (heads) of markets, shopping malls and centers to fulfill the rules on retail sales of drugs, medical products and dietary supplements

The Code of the Kyrgyz Republic on Administrative Liability Current edition Article 318. Advertising of drugs, medical products and medical equipment without permission for their production and (or) sale, issued by the executive authorities of the health care sector Amended edition Article 318. Advertising of drugs, medical products and dietary supplements without permission for their production and (or) sale, issued by the executive authorities of the health care sector, as well as advertising of drugs and medical products that are subject to restrictions concerning their application, established by the executive health care authorities

The Criminal Code of the KR Current edition Article 255. The illegal production and sale of drugs, diagnostic, preventive and therapeutic and cosmetic products and medical equipment, therapeutic and preventive products and food additives Amended edition Article 255. The illegal production and/or the sale of drugs, medical products and dietary supplements

The law on basic principles of technical regulation in the Kyrgyz Republic Current edition This Law shall not apply to the socio-economic, organizational, sanitary, medical and preventive and rehabilitation measures, implemented in the area of labor protection, as well as to the measures to prevent the emergence and the spread of mass infectious human diseases, to the prevention of human diseases, to the provision of health care services (except in cases of development, adoption and enforcement of mandatory requirements to products, including drugs, medical equipment, food products) and to soil conservation measures ………… Amended edition In Part 2 of the preamble of the Law the words "drugs", "medical equipment" to be excluded.

The Law of the KR “On the health care for the citizens of the Kyrgyz Republic” Current edition No regulation Amended edition To add the paragraph 4 to the Article 2 to read as follows: Diseases that pose a danger to others – diseases that can lead to morbidity and (or) the death of a large number of people within the short period of time.

The Law of the KR “On the health care for the citizens of the Kyrgyz Republic” Current edition No regulation Amended edition To add paragraphs 18 and 26 to the Article 2 to read as follows: Rare diseases - diseases that affect a small part of the population; Socially significant diseases - diseases the emergence and (or) distribution of which depends to a certain extent on the socio- economic conditions.

The Law of the KR “On the health care for the citizens of the Kyrgyz Republic” Current edition No regulation Amended edition To add Article 71-1 to the Law to read as follows: - Citizens that suffer from rare diseases are entitled to health care, including drug provision, in the manner prescribed by the law. The list of rare diseases is defined by the Government of the Kyrgyz Republic.

The Law of the KR “On the health care for the citizens of the Kyrgyz Republic” Current edition No regulation Amended edition To add Part II to the Article 84 to read as follows: - “Health workers have the right to prescribe drugs and to issue certificates on disability status in accordance with the order established by the law of the Kyrgyz Republic”

Thank you for attention Ахматова Г.К. Ms. G. Akhmatova