ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of January 4, 2022 No. 4

About approval of the Procedure for inclusion (exception) of medicines in (from) the National list of the main medicines and/or in (from) lists of medicines which are bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health protection, using the state assessment of medical technologies

According to Item 6-1 of the Procedure for the carrying out the state assessment of medical technologies approved by the resolution of the Cabinet of Ministers of Ukraine of December 23, 2020 No. 1300, and to the subitem 8 of Item 4, 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 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 to No. 90), I ORDER:

1. Approve the Procedure for inclusion (exception) for medicines in (from) the National list of the main medicines and/or in (from) lists of medicines which are bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health protection using the state assessment of medical technologies (further - the Procedure) which is applied.

2. Determine that:

if on the date of entry into force of this order by results of consideration of the applications and other documents submitted to Expert committee on selection and use of the main medicines (further - Expert committee), the report with conclusions and recommendations of Expert committee concerning medicine contains notes and/or cautions, the decision on inclusion of such medicines in the National list of the main medicines (further - the National list) is accepted on condition of carrying out the state assessment of medical technologies (including according to the reduced procedure) and according to the Procedure approved by this order;

if on the date of entry into force of this order of the statement, the file or the appeal of the Ministry of Health of Ukraine for carrying out the state assessment of medical technologies are provided to authorized body by the state assessment of medical technologies (further - authorized body) or by results of consideration the conclusion of authorized body is prepared, the decision on inclusion of such medicines in the National list is made according to the Procedure approved by this order;

the paragraph the fourth is excluded according to the Order of the Ministry of Health of Ukraine of 03.11.2023 No. 1905

3. Recognize invalid:

1) the order of the Ministry of Health of Ukraine 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", registered in the Ministry of Justice of Ukraine on October 24, 2016 for No. 1390/29520;

2) the order of the Ministry of Health of Ukraine of February 11, 2016 No. 84 "About approval of the Regulations on the National list of the main medicines and Regulations on expert committee on selection and use of the main medicines", registered in the Ministry of Justice of Ukraine on February 18, 2016 for No. 258/28388.

4. (I. S. Zadvornykh) to provide to management of provision of medicines submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine.

5. To impose control of execution of this order on the First Deputy Minister Komaridu A. A.

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

Approved by the Order of the Ministry of Health of Ukraine of January 4, 2022, No. 4

Procedure for inclusion (exception) for medicines in (from) the National list of the main medicines and/or in (from) lists of medicines which are bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health protection, using the state assessment of medical technologies

I. General provisions

1. This Procedure determines the procedure of inclusion (exception) of medicines in (from) the National list of the main medicines (further - the National list) and/or lists of medicines which will be bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health care (further - the List).

2. The medicines necessary for ensuring delivery of health care for the population which are registered in the procedure established by the legislation in Ukraine are included in the National list or (if necessary) also medicines which according to the centralized procedure are registered by competent authority of the European Union are registered by competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada and are applied in the territory of these countries or member states of the European Union.

The medicines registered by competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada and medicines which according to the centralized procedure are registered by competent authority of the European Union and are applied in the territory of these countries or member states of the European Union, are allowed to use in Ukraine after their state registration.

3. The medicines registered in the procedure established by the legislation in Ukraine and the unregistered medicines in the cases determined by the legislation which are bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health care in the corresponding budget year are included in the List.

4. In this Procedure terms are used in the values given in the Law of Ukraine of "Basis of the legislation of Ukraine about health care", the Procedure for carrying out the state assessment of medical technologies approved by the resolution of the Cabinet of Ministers of Ukraine of December 23, 2020 No. 1300 (further - the Procedure for carrying out the state assessment of medical technologies), the Procedure for the conclusion, execution, change and termination of agreements of the managed access, No. approved by the resolution of the Cabinet of Ministers of Ukraine of January 27, 2021 61, and other regulatory legal acts in the field of health care.

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