On December 23rd, 2016 two regulatory drafts adopted pursuant to Resolutions of the Cabinet of Ministers of Ukraine No. 862 and 863 were published on the website of the Ministry of Health of Ukraine for public comment
The draft order of Ministry of Health of Ukraine "On Approval of the Procedure for Calculating the Maximum Gross Wholesale Prices for Medicinal Products" establishes a mechanism for setting maximum gross wholesale prices for 21 International Non-Proprietary Names (INPN) of medicines for hypertensive diseases, bronchial asthma and diabetes of the second type treatment approved by Resolution of the Cabinet of Ministers of Ukraine No. 863 as of November 9th, 2016
Maximum gross wholesale price will be calculated for each form of effect of each medicine from the list of 21 INPN. These maximum indicators will be calculated based on the least unit of a form of effect of each medicinal products from the list of 21 INPN in reference countries. In other words, gross wholesale price in Ukraine cannot exceed a minimum price per unit of a form of effect established in the reference countries.
The reference countries for the purposes of external price referencing are the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia and Hungary. At the same time, the sources from which the Ministry of Health will receive the value of gross wholesale prices in these countries are listed in the annex to the draft Order.
Please note that business entities are not involved to calculate the maximum gross wholesale prices. All maximum wholesale prices for medicines are contained in a single register maintained by the Ministry of Health and published on its website.
Monitoring of changes in wholesale prices, as well as updating of the register of maximum gross wholesale prices of medicinal products will be carried out on a quarterly basis by the fifth day of the first month of the next quarter (January 5th, April 5th, July 5th and October 5th) and will be made public on the official website of the Ministry of Health of Ukraine. Carrying out such monitoring and updating the Register is assigned to a state-owned enterprise belonging to the sphere of the Ministry of Health management.
We remind you that Resolution of the Cabinet of Ministers of Ukraine No. 862 as of November 9th, 2016 must start introducing the maximum prices of medicinal products included in the list of 21 INPN of medicines for hypertensive diseases, bronchial asthma and diabetes of the second type treatment from January 1st, 2017.
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