ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 29, 2016 No. 1423

About approval of limiting Procedure of payments of wholesale selling prices on medicines on the basis of the reference prices

According to Item 5 of the resolution of the Cabinet of Ministers of Ukraine of November 9, 2016 "About state regulation of the prices of medicines" I order to No. 862:

1. Approve limiting Procedure of payments of wholesale selling prices on medicines on the basis of the reference prices which is applied.

2. To management of pharmaceutical activities and quality of pharmaceutical products (Lyaskovsky T. M.) provide submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the deputy minister of health care Ilik R. R.

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

Approved by the Order of the Ministry of Health of Ukraine of December 29, 2016, No. 1423

Limiting procedure of payments of wholesale selling prices on medicines on the basis of the reference prices

1. This Procedure determines the mechanism of limiting calculation of wholesale selling prices on the basis of the reference prices determined taking into account data on the prices of the medicines registered in the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia and Hungary (further the reference countries).

2. Action of this Procedure extends to the finished pharmaceutical products registered in Ukraine which are bought and/or the cost of which is compensated, included in the list of the international unlicensed names of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of March 17, 2017 No. 152 (further - the List of MNN).

3. The reference prices of medicines are determined on the basis of data on the registered prices namely as median of the registered prices for each dosage form in terms of certain dose (DDD) according to WHO recommendations concerning the List of MNN received from official sources of authorized state bodies of the reference countries.

4. The reference prices of medicines from the List of MNN are determined in national currency of Ukraine.

Transfer of the reference prices of 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 for pricing date.

5. NSZU calculates extreme wholesale selling price of dosage form of medicine from the List of MNN on the following stages:

1) calculation of quantity of DDD in unit of dosage form of medicine from the List of MNN in the reference country is perfromed on the following formula:

the number of DDD (in unit of dosage form of medicine) = dose of unit of dosage form of medicinal means / DDD of WHO;

2) calculation of the price of unit of dosage form of medicine in the reference country is perfromed on the following formula:

the registered unit price of medicine = the registered price for packaging of medicinal means / quantity of units of medicine in packaging;

3) calculation of the price of the DDD medicine of dosage form from the List of MNN in the reference country is perfromed on the following formula:

the price of the DDD medicine of dosage form (RTs) = the registered unit price of medicinal means / quantity of DDD (in unit of dosage form of medicine);

4) calculation of the reference price in the reference country of dosage form of the international unlicensed name of medicine (Rtsrk) is determined as median of the prices of the DDD medicine of dosage form from the List of MNN in the reference country. Calculation is made on the following formula:

                         Rtsrk = MEDIANA (RTs 1... RTs N)

5) limiting calculation of wholesale selling price of dosage form for medicine from the List of MNN in terms of certain dose (DDD) is calculated by formula:

POVTs DDD = MEDIANA (Rtsrk 1... Rtsrk N),

where POVTs DDD - extreme wholesale selling price of certain daily dose (DDD).

 6. The Ministry of Health keeps the limiting register of wholesale selling prices on medicines in electronic form based on the calculations provided to NSZU for the form given in appendix to this Procedure which is published on its official website (www.moz.gov.ua).

7. Updating of the limiting register of wholesale selling prices on medicines is performed two times a year in the first working day of January and July of the current year. Recalculation of the limiting register of wholesale selling prices on medicines is performed also in case of change of the official rate of hryvnia to US dollar established by national bank of Ukraine, more than for 5 percent a month or for 10 percent in quarter.

8. Information on extreme wholesale selling prices of unit of dosage form of each force of effect of each medicine from the List of MNN in the reference countries in the Ministry of Health of Ukraine moves the state company which belongs to the sphere of its management.

Appendix

to limiting Procedure of payments of wholesale selling prices on medicines on the basis of the reference prices (Item 6)

The limiting register of wholesale selling prices on medicines

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