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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of January 27, 2021 No. 61

Some questions concerning agreements of the managed access and suspension of action of paragraph one of Item 1-2 of the resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 No. 333

According to article 79-1 of Bases of the legislation of Ukraine about health care the Cabinet of Ministers of Ukraine decides:

1. Approve enclosed:

Procedure for negotiation under agreements of the managed access;

Procedure for the conclusion, execution, change and termination of agreements of the managed access;

standard form of the agreement of the managed access.

2. Make changes which are applied to resolutions of the Cabinet of Ministers of Ukraine.

3. Determine that the procedure of agreements of the managed access is entered since February 15, 2021.

4. Suspend till December 31, 2021 paragraph one of Item 1-2 of the resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 No. 333 "Some questions of state regulation of the prices of medicines and products of medical prescription" (The Official Bulletin of Ukraine, 2009 No. 27, Art. 906; 2017, No. 28, Art. 815; 2020, No. 10, Art. 373; 2021, No. 2, the Art. 94) regarding carrying out the state assessment of medical technologies.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of January 27, 2021 , No. 61

Procedure for negotiation under agreements of the managed access

1. This Procedure determines legal and organizational basis, the procedure and conditions of negotiation (further - negotiations) by agreements of the managed access.

2. Terms in this Procedure are used in the value given in Bases of the legislation of Ukraine on health care, the Law of Ukraine "About medicines", the Procedure for the conclusion, execution, change and termination of agreements of the managed access, No. 61 approved by the resolution of the Cabinet of Ministers of Ukraine of January 27, 2021.

The term "authorized body by the state assessment of medical technologies" is used in the value given according to the procedure of carrying out the state assessment of medical technologies, approved by the Cabinet of Ministers of Ukraine of December 23, 2020 No. 1300 (The Official Bulletin of Ukraine, 2021, No. 2, the Art. 94).

3. Negotiations are held with respect for the principles determined by Procedure for the conclusion, execution, change and termination of agreements of the managed access, negotiation group on questions of agreements of the managed access (further - negotiation group).

4. Negotiation groups are formed by the Ministry of Health.

The Ministry of Health determines negotiation group which will hold the corresponding negotiations, in the order which is the basis for preparation and negotiation.

5. The chairman, the deputy (deputies) the chairman, members of negotiation group are part of negotiation group. The members of the corresponding negotiation group affirm the Ministry of Health.

The negotiation group can recruit other experts and specialists (translators, lawyers and so forth) in its work.

6. The negotiation group holds negotiations with the applicant (authorized representative) in time, established according to the procedure of the conclusion, execution, change and the termination of agreements of the managed access.

7. The negotiation group begins preparation of negotiations within three working days from the date of receipt of the order of the Ministry of Health.

For this purpose according to the solution of Chapter of negotiation group, and in case of its absence - the vice-chairman the secretary of negotiation group convenes meeting of her members on purpose:

discussions and approvals of the action plan on the organization of negotiations;

discussions of need of attraction for preparation and negotiation of experts and specialists (translators, lawyers and so forth) who are not part of negotiation group;

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