It is registered
Ministry of Justice of Ukraine
October 24, 2016
No. 1390/29520
of October 7, 2016 No. 1050
About approval of the Regulations on implementation of selection of medicines for entering into the National list of the main medicines
According to Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267, and to the paragraph to the fourth the subitem 1 of Item 2 of the resolution of the Cabinet of Ministers of Ukraine of December 9, 2015 No. 1134 "About introduction of amendments to resolutions of the Cabinet of Ministers of Ukraine of October 17, 2008 No. 955 and of March 25, 2009" I order to No. 333:
1. Approve Regulations on implementation of selection of medicines for entering into the National list of the main medicines which is applied.
2. To provide to management of pharmaceutical activities and quality of pharmaceutical products 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 Ilik R. R.
4. This order becomes effective from the date of its official publication.
Acting minister
V. Suprun
Approved by the Order of the Ministry of Health of Ukraine of October 7, 2016 No. 1050
1. This Provision determines procedure for selection of medicines (further - LS) for entering into the National list of the main medicines (further - the National list) which is performed by Expert committee on selection and use of the main medicines (further - Expert committee) according to the Regulations on the National list of the main medicines approved by the order of the Ministry of Health of Ukraine of February 11, 2016 No. 84, registered in the Ministry of Justice of Ukraine on February 18, 2016 for No. 258/28388, by forming and modification of the National list.
2. The expert committee creates the National list in the following procedure:
1) is determined by the list of priority diseases and pathological conditions taking into account:
population (epidemiological) indicators and indicators of burden of disease (economical and social expression of the consequences and problems caused by disease);
regulatory requirements according to the industry, national state programs installed by social guarantees;
features of provision to citizens of medical care of all types;
2) creates the recommended version of the National list taking into account certain list of priority diseases and pathological conditions on the basis of the last current version of the basic list of the main medicines (Model List of Essential Medicines) recommended by the World Health Organization (further - WHO);
3) represents the recommended version of the National list to the Ministry of Health of Ukraine.
3. The expert committee reviews the National list in 2017 in the following procedure:
till November 1, 2017:
submits the list of priority diseases and pathological conditions on approval to the Ministry of Health of Ukraine;
reviews the National list taking into account the last current version of the basic list of the main medicines (Model List of Essential Medicines) recommended to WHO, nomenclatures of the medicines which are purchased for budgetary funds of industry standards and submits to the Ministry of Health of Ukraine the list of medicines which recommend to add the National list, and also publishes this list of medicines on the website.
4. The expert committee performs review of the National list in the following procedure:
The secretariat of Expert committee accepts 1) to consideration of the application about modification of the National List (further - the statement) which form is given in appendix 1 to this Provision. Features of execution of the statement are given in appendix 2 to this Provision;
2) within 180 calendar days considers applications according to the procedure of priority of receipt and makes according to them decisions;
3) by results of the decisions made on consideration of the applications creates the next edition of the National list till July 01 of the current year and represents to the Ministry of Health of Ukraine;
4) till November 01 of the current year is reviewed by the list of priority diseases and pathological conditions taking into account the established indicators and gives it to the Ministry of Health of Ukraine.
5. In case of need, proceeding from the illness rates of the population, prevalence of diseases and death rate, industry standards in health sector and/or nomenclatures of the medicines which are purchased for budgetary funds, the Expert committee can initiate extraordinary modification of the National list.
6. The documents confirming comparative efficiency (effectiveness), comparative safety and economic feasibility of LS are enclosed to the application.
7. Information containing in Items 14 and 14 of the statement is published on the website of Expert committee.
Information containing in Items 5 - the 13th statement and the documents attached to it is confidential.
8. The applicant bears responsibility for accuracy of the information, containing in provided to Expert committee the statement and the documents attached to it.
9. The statement and documents attached to it are considered by Expert committee according to the procedure and in the terms determined by the Regulations on the National list of the main medicines approved by the order of the Ministry of Health of Ukraine of February 11, 2016 No. 84, registered in the Ministry of Justice of Ukraine on February 18, 2016 at No. 258/28388.
Head of department of pharmaceutical activities and quality of pharmaceutical products
T. M. Lyaskovsky
to Regulations on implementation of selection of medicines for entering into the National list of the main medicines (the subitem of 1 Item 4)
Statement for modification of the National list of the main medicines
See Appendix 1 (15Kb In original language)
to Regulations on implementation of selection of medicines for entering into the National list of the main medicines (the subitem of 1 Item 4)
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The document ceased to be valid since January 28, 2022 according to Item 1 of the Order of the Ministry of Health of Ukraine of January 4, 2022 No. 4