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It is registered

Ministry of Justice of Ukraine

February 18, 2016

No. 258/28388

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

(as amended on 03-02-2021)

According to paragraphs to second and third 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 No. 333", to the subitem 6 of item 4 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, I order:

1. Approve:

1) Regulations on the National list of the main medicines which are applied;

2) Regulations on expert committee on selection and use of the main medicines which are applied.

2. Declare invalid the order of the Ministry of Health of Ukraine of May 24, 2005 No. 226 "About approval of the Regulations on the National list of the main medicines and products of medical appointment and Regulations on Advisory council on forming, modification and amendments in the National list of the main medicines and products of medical appointment", registered in the Ministry of Justice of Ukraine on June 7, 2005 at No. 635/10915.

3. 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.

4. To impose control of execution of this order on the deputy minister of Shafransky V. V.

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

Minister

A. Kvitashvili

It is approved:

Chairman of the Public regulatory service of Ukraine

 

K. Lyapina

Approved by the Order of the Ministry of Health of Ukraine of February 11, 2016 No. 84

Regulations on the National list of the main medicines

I. General provisions

1. This Provision determines structure and contents of the National list of the main medicines (further - the National list), and also procedure and criteria of entering into it.

2. Medicines to which the high-quality, effective, safe medicines necessary for ensuring delivery of health care for the population in healthcare institutions belong, irrespective of pattern of ownership are included in the National list (further - UZ).

3. Medicines are included in the National list taking into account the illness rates of the population, prevalence of diseases and death rate, proofs of comparative efficiency (effectiveness), safety and economic feasibility of medicines, and also industry standards in health sector and the level of financing of medical care.

4. Medicines shall be present at UZ at any time, at necessary quantity and at the corresponding dosage forms (for medicines) for ensuring proper level of functioning in health sector.

5. Consideration of offers on modification of the National list performs the expert committee on selection and use of the main medicines (further - expert committee) formed by the Ministry of Health of Ukraine.

II. Structure and contents of the national list

1. The structure and contents of the National list are based on the last edition of the Basic list of the main medicines recommended by the World Health Organization (further - WHO).

2. The national list consists from:

the main list which includes the most effective, safe medicines with high rates of economic feasibility for priority diseases and pathological conditions which are determined, proceeding from the modern and expected importance for health care;

the additional list which includes medicines for the priority diseases and pathological conditions requiring the specialized diagnostic or monitoring equipment, and/or specialized medical care and/or training of specialists. In case of doubts such medicines can be included in the main list as additional at the permanent high cost or smaller cost efficiency in various conditions.

3. The registered and unregistered medicines in Ukraine are included in the National list.

Medicines are allowed to application in Ukraine, are bought and compensated at the expense of state and local budgets after their state registration.

4. Medicines are included in the National list according to the international unlicensed names.

III. Procedure for modification of the national list

1. Modification of the National list is initiated by expert committee, physical persons and legal entities.

2. 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.

3. In case of initiation of modification of the National list by physical persons and legal entities in expert committee move the statement according to the form established by the current legislation and information confirming comparative efficiency (effectiveness), safety and economic feasibility of medicines.

4. Data on the received applications (the initiator of the offer, receipt date, contents of the offer) are published on the website of expert committee for consideration and submission of offers within ten days after their representation.

5. Consideration of the applications and the submitted documents arriving in expert committee is performed till 180 calendar days from the date of their giving according to the procedure of receipt priority.

Information on condition of consideration of all submitted applications is published on the website of expert committee.

6. In case of discrepancy of the submitted application to the established requirements the expert committee in writing notifies on it the applicant and provides it twenty-day term for elimination of the revealed shortcomings. In case of failure to carry out of the specified requirements at the scheduled time the statement remains without consideration what in writing notify the applicant on.

7. In the course of consideration of question of modification of the National list the expert committee performs assessment of comparative efficiency (effectiveness), safety and economic feasibility of medicines. The expert committee can request the additional information necessary for implementation of such assessment from applicants.

8. By results of assessment of comparative efficiency (effectiveness), safety and economic feasibility of medicines the expert committee makes the decision to recommend or not to recommend medicine for inclusion in or exceptions of the National list.

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