Deputy of Minister of Health of the Republic of Belarus Godovalnikov Gennadiy

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1 Implementation of the Concept of the development of the pharmaceutical industry of the Republic of Belarus for years and the period up to Deputy of Minister of Health of the Republic of Belarus Godovalnikov Gennadiy

2 The main directions of development of the pharmaceutical industry 2 the organization of management of the pharmaceutical industry; improving on the level of scientific support for the pharmaceutical industry; retooling of existing and creation of new businesses and industries, development of new technologies; training and skills development of the staff ; formation of the sales system in order to substitute import and promote products in foreign markets.

3 The structure of the pharmaceutical industry of the Republic of Belarus 3 s subordinated to the Department of the pharmaceutical industry of the Ministry of Health of the Republic of Belarus Major enterprises of private ownership s producing medicines from plant raw materials Scientific organizations and institutions Other enterprises with a license to produce medicines РУП "Белмедпрепараты", ОАО "Борисовский завод медицинских препаратов", УП "Минскинтеркапс", ОАО "Несвижский завод медицинских препаратов", ОАО "Экзон", СОАО "Ферейн" ООО "ФАРМТЕХНОЛОГИЯ", СП ООО "Фармлэнд", СООО "Лекфарм", СООО "ТрайплФарм" ООО "Падис' С", НПК "Биотест", ООО "Калина", КСУП "Совхоз "Большое Можейково", ООО "Рубикон" ГНУ "ИФОХ НАН Беларуси ", ГУ "РНПЦ гематологии и трансфузиологии" Минздрава, РПУП "Академфарм", УП "ХОП ИБОХ НАН Беларуси", УНПРУП "УНИТЕХПРОМ БГУ" БРУП "Гидролизный завод", ЗАО "БЕЛАСЕПТИКА", ЗАО "Фарматех", ИП "Инкраслав", ОАО "БелВитунифарм" TOTAL: 25

4 4 The results of the work of the pharmaceutical industry in 2011 Issued drugs (U.S. $ million). 235,2 including enterprises of the Department (U.S. $ million). 184,6 Supplied to the domestic market by the enterprises of the Department (U.S. $ million., including carry-over storage) 93,2 Exported by the enterprises of the Department (U.S. $ million., including carry-over storage) 102,0 The foreign trade balance (U.S. $ million) 25,9 Specific weight of innovative products, in the total volume, shipped,% 19,9 %

5 List of pharmaceutical manufacturing companies of the Republic of Belarus certified for compliance with Good Manufacturing Practice (GMP) 5 Production Certificate production of powders for injections in vials BY/ Public Corporation «Borisovskiy zavod medicinskikh preperatov» Unitary «Minskinterkaps» Republican Unitary «Belmedpreparaty» production of drugs in tablet BY/ production of injection solutions in ampoules of vacuum filling production of injection solutions in ampoules of syringe filling BY/ BY/ BY/ BY/ production of soft dosage forms BY/ production of hard gelatin capsules and drugs in hard gelatin capsules BY/ production of drugs in soft gelatin capsules BY/ production of liquid sterile pharmaceuticals in vials and ampoules BY/ section for the production of drugs in tablets and capsules BY/ production of drugs in capsules BY/ Public corporation «Ekzon» production of drugs in tablets BY/ Public Corporation «Nesvizhskiy zavod medicinskikh preperatov» Joint Limited Liability Company «Lekfarm» production of infusion solutions in plastic containers with the use of technology Bottelpack" BY/ production of solid dosage forms in tablets BY/

6 6 Scientific supply of the state, state scientific and technical programs and innovation projects (in all 77 tasks) State programs State scientific and technical programs Innovative projects State program «Pharmaceutica l products for substitution of import» State program «innovative biotechnology» State scientific and technical program «Pharmaceutical substances and drugs» At the expense of state budget At the expense of innovation fund of the Ministry of Health Subprogram «The normative legal base» Subprogram «Medical biotechnology» Subprogram «Medicines» Subprogram «Amino Acids» organization: Unitary «LOTIOS» organization Unitary «LOTIOS» НИИ ФХП БГУ organization НИИ ФХП БГУ organization ИФОХ НАНБ organizations executing tasks ИОНХ НАНБ НИИ ЯП БГУ Unitary «LOTIOS» organizations executing tasks Unitary «LOTIOS»

7 The financial results of the enterprises of the Department of pharmaceutical industry of the Ministry of Health 7 Name of enterprise s of the Department Republican Unitary «Belmedpreparaty» Public Corporation «BZMP» Public Corporation «Nesvizhskiy ZMP» Public Corporation «Ekzon» Unitary «Minskinterkaps» Gains and losses(-) from sales of goods, products, services growth Return on sales, % Arrears of loans rate,% growth rate , ,0 219,9 27,6 22, , ,0 163, , ,0 189,3 24,9 22, , ,0 118, , ,0 240,7 31,5 23, , ,0 412,1 535,0 583,0 91,8 1,3 2, , ,0 112,5 8104,0 1890,0 428,8 26,3 13,4 6418,0 619,0 1036, , ,0 268,8 39,5 26, ,0 8890,0 286,0,%

8 Thous and rubles Prices for domestic medicines in comparison with foreign analogs Ambroxol Enalapril Diclofenac Fluconazolе Azithromycin Domestic medicine Import analog 8

9 Modernization of existing and construction of new pharmaceutical companies 9 Name of organization Name of project, terms of realization The project cost, million rubles The expected result Public Corporation «BZMP» Creation of production of solid dosage forms Creating capacity : 1000 million of tablets и 70 million of capsules per year Reconstruction of the ampoule production(3rd and 4th launch complexes) Bringing to the requirements of GMP standards without increase in production capacity Republican Unitary «Belmedpreparaty» Unitary «Minskinterkaps» Open joint-stock company «Ferein» Public Corporation «Ekzon» TOTAL: Reconstruction of the producton of antitumor drugs in the form of freeze-dried powders and solutions for injection The creation of new drugs appropriate to the international standards of GMP (sterile packing of powder) Reconstruction of the production of pharmaceutical substances to bringing it in line with GMP standards Creating a new production building for the production of hard drugs and soft gelatin capsules Production of liquid and solid dosage forms (1st and 2nd stage) Reconstruction and organization of manufacturing of new dosage forms The output, bottles (not cytostatics ) 4573 thousand of bottles per year; Vials of cytostatics 454 thousands of bottles per year Bottles, sterile packing of powder antibiotics 33,7 million of bottles per year Bringing to the requirements of GMP standard Creating capacity 1500 millions of capsules per year Creation of capacities: for ampoules 50 million per year, for cartridges 6 million per year, for tablets 190 per year, for capsules 5 million per year Implementation of the first stage with an increase in existing capacity on 10% million of rubbles (116,2 million U.S. dollars)

10 The development of new medicines 10 Name of medicines Year IN ALL s of the Department Other organizations of the Republic TOTAL

11 Provision of measures of state support for domestic producers of medicines 14 Volumes and directions of usage of financial assistance Year IN ALL Purchasing of raw materials, supplies, licenses for the production of new innovative medicines 28,2 8,0 7,8 44,0 Reimbursement of some costs associated with work on the registration of pharmaceutical substances and medications 1,8 2,0 2,2 6,0 TOTAL 30,0 10,0 10,0 50,0

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