Document from CIS Legislation database © 2003-2021 SojuzPravoInform LLC

RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of February 3, 2021 No. 82

About approval of the Procedure for forming of the list of the unregistered medicines (according to the international unlicensed names) which can be imported on the territory of Ukraine for the purpose of delivery by results of the purchase which is carried out by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care for means of the government budget

According to part nine of article 17 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

Approve the Procedure for forming of the list of the unregistered medicines (according to the international unlicensed names) which can be imported on the territory of Ukraine for the purpose of supply by results of the purchase which is carried out by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care for means of the government budget which is attached.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of February 3, 2021 , No. 82

Procedure for forming of the list of the unregistered medicines (according to the international unlicensed names) which can be imported on the territory of Ukraine for the purpose of supply by results of the purchase which is carried out by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care for means of the government budget

1. This Procedure determines the mechanism of forming of the list of the unregistered medicines which can be imported on the territory of Ukraine for the purpose of supply by results of the purchase which is carried out by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care at the expense of means of the government budget (further - the list), and also modification of it.

2. The list is created according to the international unlicensed names.

3. Offers on forming of the list, modification of it move in the Ministry of Health.

4. For consideration of offers on modification of the list the Ministry of Health can form the working group on questions of forming of the list.

5. Offers on forming of the list, modification of it can move the following subjects:

1) central executive bodies;

2) person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care at the expense of means state and local budgets;

3) the specialized organization which conducts procurement;

4) regional, Kiev and Sevastopol city state administrations;

5) healthcare institutions;

6) institutes of civil society.

6. The subject together with the offer, gives:

1) the letter of appeal in any form in which information on medicine compliance to requirements for inclusion in the list, the stipulated in Article 17 Laws of Ukraine "About medicines" is specified the name, release form, dosage of medicine and the name of disease, for prevention and/or treatment of which is appointed such means, the data (expected settlement or statistical) about the number of patients with such disease, and also reasons for need of purchase of the corresponding medicine;

2) the copy of the document confirming registration of medicine in the United States of America, the Swiss Confederation, Japan, Australia, Canada or registration by competent authority of the European Union according to the centralized procedure it is also applied in the territory of one of the following countries;

3) copies: the instruction about use of medicine stated in original language (in the language other than state), the short characteristic of medicine stated in original language (in the language other than state), approved according to normative requirements of the country applicant/producer) and persons assured by the signature, submitting the letter of appeal.

7. By results of consideration of offers and documents for inclusion in the list of the unregistered medicine the Ministry of Health makes the decision on coordination and the recommendation concerning inclusion in the list of the unregistered medicine or refusal in coordination of inclusion of the unregistered medicine.

8. The refusal in coordination of inclusion in the list of the unregistered medicine can be performed in the presence of at least one of the following bases:

1) documents are submitted not in full;

2) in Ukraine there are alternative means for prevention and/or treatment of the corresponding diseases according to the State register of medicines;

3) the need for the unregistered medicines for Ukraine is not limited, that is medicine is provided for use by large number of patients;

4) the unregistered medicines are in accordance with the established procedure not allowed to application in the territory of one of the following countries: The United States of America, the Swiss Confederation, Japan, Australia, Canada or according to the centralized procedure in member states of the European Union;

5) the unregistered medicines are not deposited in the nomenclature of medicines approved by the Ministry of Health.

9. The Ministry of Health makes the decision within ten working days from the date of receipt of the letter of appeal together with documents, the stipulated in Item 6 presents About.

10. The Ministry of Health within ten working days from decision date and by results of carrying out public discussion according to the legislation submits to the Cabinet of Ministers of Ukraine proposals concerning forming of the list, changes in it, and also the List of medicines, medical products and supportive applications to them which are bought in pursuance of the relevant agreements (agreements) signed by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care in the directions of use of budgetary funds for the corresponding year.

11. In case of detection at least one of the bases specified in Item 8 of this Procedure unregistered medicinal means is subject to exception of the list about what the Ministry of Health within 15 working days from the date of identification of such bases submits to the Cabinet of Ministers of Ukraine relevant proposals.

12. The Ministry of Health provides implementation of annual monitoring of availability of the bases for modification of the list when forming the nomenclature of medicines which is determined by the Ministry of Health, and/or in the List of medicines, medical products and supportive applications to them which are bought in pursuance of the relevant agreements (agreements) signed by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care in the directions of use of budgetary funds for the corresponding year.

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.