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REGULATORY UPDATES
On Sept 28 , 2015 , in the Verkhovna Rada of Ukraine the Draft Law of Ukraine 3180 “ On amendments to the subparagraph 193.1 of the paragraph 193 of the Tax Code of Ukraine ( on creating favorable conditions for improving the provision of health care institutions and citizens with affordable drugs )” developed by the MoH of Ukraine was registered .
The Draft Law is developed to eliminate the legal conflicts that occurred in practice and leads to increased costs for the purchase of drugs by citizens and increasing budget expenditures for the purchase of drugs made in pharmacies .
The adoption of this Draft Law will expand opportunities for provision of health facilities and poor inhabitants with affordable medicines produced according to the recipes of doctors and by order of medical institutions .
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On Aug 26 , 2015 the Resolution of the Cabinet of Ministers of Ukraine # 609 “ On approval of the list of licensing authorities and recognition of some Resolutions of the Cabinet of Ministers of Ukraine as invalid ” entered into force .
The Resolution assumes that since its validation date the functions of the licensing of economic activities of drug manufacturing , drugs importing , wholesale and retail sale of drugs , is conducted by the State Administration of Ukraine on medical products and drug control .
However , the new Administration is not formed yet , and its management is not administered , so it have not actually started its functioning .
-- On Sept 4 , 2015 , the State
Regulatory Service provided the Clarifications (# 6528 / 0 / 20- 15 ), stating that before the State Administration of Ukraine on medical products and drug control is created , the licensing on the activities indicated , amendments to the licenses , their renewal and verification of compliance with license conditions is carried by the State Administration of Ukraine on medical products .
The Resolution # 609 applies only to the licensing activity and does not affect the state quality control of drugs .
The new mechanism also obliges the MoH of Ukraine to automatically review and update the price of imported products in the Register of wholesale selling prices of drugs and medical products , in case if the official Ukrainian Hryvnya exchange rate to foreign currencies ( dollar or euro , depending on the contract ’ s currency and , relatively , the declaration currency ) is changed by more than 5 % during the current month . In this case , the MoH have to renew the prices until the 10 th day of the following calendar month through increase or decrease of prices in the Register .
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On Sept 21 , 2015 , the MoH of Ukraine presented the Draft Order “ On amendments to the list of products that can be bought and sold by pharmacies and their subdivisions ”. As the explanatory note states that , the Draft Order is developed in order to expand the assortment of goods available for purchase in pharmacies . The proposed edition of the list includes 20 items , which is seven more than the current edition stipulates . Particularly , the list is enlarged with the following products : instruments and tools for oral care , skin , nails , hair ; items and means for aromatherapy ( aromatic lamps , oils , sticks , candles ); various means to combat bad habits ; laboratory ware , etc .
In addition , the new version the old list is supplemented with new products ; in particular , the position of the functional foods is supplemented with products for diabetic nutrition , biologically active additives and others .
The document also provides that pharmaceutical institutions and their structural units carry the purchase and sale of these goods on the condition of maintenance of the selected area for storage .
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On Sept 25 , 2015 , the Verkhovna Rada of Ukraine registered the Draft Law “ On amendments to article 15 of the Law of Ukraine “ On drugs ” ( on improvement of the legislation regulating the powers of state control body over the quality of drugs )”.
The Draft Law provides that production and sale of drugs should now be terminated only by a court decision . These amendments are made to predict legal conflict leading to exceeding of the competence of the officials of the central executive body that implement the state policy in the field of quality and safety of drugs .
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Please , familiarize yourself with KPMG bulletings on Ukrainian pharmaseutical sphere for additional information about regulatory updates .
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KPMG Pharma Bulleting . Issue No . 47 . August 2015 .
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KPMG Pharma Bulleting . Issue No . 48 . September 2015 .
Ukrainian Pharmaceutical Market Monthly : September / August 2015