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The document ceased to be valid since July 1, 2014 according to Item 1 of the Order of the Ministry of Health of Ukraine on May 27, 2014 No. 358.

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Ministry of Justice of Ukraine

January 25, 2014

No. 164/24941

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of January 21, 2014 No. 57

About approval of the Procedure of payments of limit of wholesale selling prices on insulin medicines on the basis of the comparative (reference) prices of such medicines

According to the subitem 1 of Item 3 of the resolution of the Cabinet of Ministers of Ukraine of August 14, 2013 No. 732 "About realization of pilot project on implementation of state regulation of the prices of insulin medicines" (with changes) PRIKAZYVAYU:

1. Approve the Procedure of payments of limit of wholesale selling prices on insulin medicines on the basis of the comparative (reference) prices of such medicines that is applied.

2. To provide to department concerning quality of the medical and pharmaceutical care (T. Donchenko) submission of this order on state registration in the Ministry of Justice of Ukraine.

3. I reserve control over the implementation of this order.

4. This order becomes effective from the date of its official publication.

Minister

R. Bogatyreva

Approved by the Order of the Ministry of Health of Ukraine of January 21, 2014 No. 57

Procedure of payments of limit of wholesale selling prices on insulin medicines on the basis of the comparative (reference) prices of such medicines

I. General provisions

1.1. This Procedure determines the mechanism of calculation of limit of wholesale selling prices on insulin medicines with use of the mechanism of external summarizing of the prices and on the basis of the declared wholesale selling prices which developed in Ukraine.

1.2. Action of this Procedure extends to the insulin medicines registered in Ukraine and are entered in the State register of medicines.

1.3. According to the resolution of the Cabinet of Ministers of Ukraine of August 14, 2013 No. 732 "About realization of pilot project on implementation of state regulation of the prices of insulin medicines" (with changes) (further - the Resolution) the Ministry of Health of Ukraine (further - the Ministry of Health of Ukraine) creates the list of trade names of the medicines with the corresponding dosage, release form, force of action and packaging entered in the State register of medicines of Ukraine (further - the List of TN).

1.4. Limits of wholesale selling prices on medicines of insulin are conducted on papers and published on the official site of the Ministry of Health of Ukraine (www.moz.gov.ua) in the form given in appendix 1 to this Procedure.

1.5. In this Procedure terms are used in the following values:

limit of wholesale selling price (GROVTS) on insulin medicine - the wholesale selling price of packaging of medicine calculated for each force of action taking into account quantity of units and form of release in primary package of each medicine from the List of TN;

the declared wholesale selling price on medicine (OVTsR) - wholesale selling price on medicine, is entered in the register of wholesale selling prices on medicines and products of medical appointment;

the international unit of activity (MO) - unit of measure of force of effect of medicine which is based on its biological activity;

wholesale selling price of external summarizing (OVTsZR) - arithmetic-mean value of wholesale selling prices of each force of action taking into account quantity of units and form of release in primary package of each medicine of insulin from the List of TN in the reference countries.

1.6. External summarizings it is performed according to official sources of authorized state bodies in the Republic of Bulgaria, the Republic of Moldova, the Republic of Poland, the Slovak Republic and the Czech Republic.

If the corresponding medicine is not presented at the market in the specified states or presented at the market in two and less states, external summarizings is performed taking into account these official sources of authorized state bodies in the Republic of Latvia, Hungary and the Republic of Serbia.

If the secondary package corresponding by the size is not presented at the market in the specified states, the prices this on level close on package size taking into account the cost of the international unit of activity are used.

Official sources of authorized state bodies in the reference countries, types of the registered prices and currencies in the reference countries, and also frequency of updating of data are given in appendix 2 to this Procedure.

1.7. Limits of wholesale selling prices on medicines of insulin are established in national currency of Ukraine.

1.8. The price conversion on insulin medicines from foreign currencies of the reference countries in national currency of Ukraine is performed on the official rate established by the National Bank of Ukraine as of December 1 of the corresponding year and for June 1, 2014.

II. Determination of limit of wholesale selling prices

2.1. The limit of wholesale selling prices (GROVTS) on medicines of insulin is determined with use of the mechanism of external summarizing of the prices and taking into account the declared wholesale selling prices which developed in Ukraine on medicines from the List of TN.

2.2. External summarizings of wholesale selling price on medicine which is included in the List by TN it is performed as arithmetic-mean value of interval of the prices for each medicine from the List of TN according to wholesale selling prices on the corresponding medicines, received from official sources of authorized state bodies of the reference countries in compliance of item 1.6 of the Section I of this Procedure.

2.3. The declared wholesale selling price on medicine (OVTsR) is entered in the register of wholesale selling prices on medicines and products of medical appointment as of December 1 of the corresponding year (the official site of the Ministry of Health of Ukraine - http://www.moz.gov.ua/ua/portal/register_prices_drugs/).

2.4. The limit of wholesale selling prices on medicines (counting on the international unit of activity) from the List of TN is calculated as arithmetic-mean value of the wholesale selling price of external summarizing (OVTsZR) determined according to Item 2.2 of this Section with inclusion in the specified interval of the declared wholesale selling price on medicine (OVTsR) determined according to Item 2.3 of this Section.

2.5. If OVTsR is less than the price, determined according to Item 2.4 or Item 2.6 of this Section, GrOVTs is determined at the level of the declared wholesale selling price on medicine (OVTsR) determined according to Item 2.3 of this Section.

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