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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of December 23, 2021 No. 1378

About determination of authorized body in the sphere of donorship of blood and components of blood, functioning of system of blood and introduction of amendments to some resolutions of the Cabinet of Ministers of Ukraine

According to article 6 of the Law of Ukraine "About safety and quality of donor blood and components of blood" the Cabinet of Ministers of Ukraine decides:

1. Determine Public service by medicines and control of drugs by authorized body in the sphere of donorship of blood and components of blood, functioning of system of blood.

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

3. This resolution becomes effective from the date of its publication, except Item of 3 changes approved by this resolution which becomes effective since April 1, 2022.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 23, 2021 No. 1378

Changes which are made to resolutions of the Cabinet of Ministers of Ukraine

1. In appendix 1 to the resolution of the Cabinet of Ministers of Ukraine of April 5, 2014 No. 85 "Some questions limiting approval of number of workers of the device and territorial authorities of the central executive bodies, other state bodies" (The Official Bulletin of Ukraine, 2014, No. 29, Art. 814; 2015, No. 86, Art. 2882; 2016, No. 46, Art. 1668):

line item

"Gosleksluzhba

127

127

433

307"

replace with the following line item:

"Gosleksluzhba

138

138

422

307".

2. Item 10 of the list of bodies of the licensing approved by the resolution of the Cabinet of Ministers of Ukraine of August 5, 2015 No. 609 (2015, No. 68, the Art. 2232) in the column "Type of Economic Activity" to add the Official Bulletin of Ukraine with the paragraph of the following content:

"procurement and testing of donor blood and components of blood, irrespective of their final appointment, conversion, storage, distribution and realization of donor blood and the components of blood intended for transfusion".

3. In the Regulations on Public service of Ukraine on medicines and control of drugs approved by the resolution of the Cabinet of Ministers of Ukraine of August 12, 2015 No. 647 (The Official Bulletin of Ukraine, 2015, No. 72, Art. 2354; 2017, No. 50, Art. 1550):

1) Item 1 after words of "counteraction to their illegal address" to add with words ", donorship of blood and components of blood, functioning of system of blood";

Item 3 to add 2) with paragraphs of the following content:

"licensing of economic activity on procurement and testing of donor blood and components of blood, irrespective of their final appointment, on conversion, storage, distribution and realization of donor blood and the components of blood intended for transfusion;

realization of state policy in the sphere of donorship of blood and components of blood, functioning of system of blood, conducting check of compliance of conditions of activities of the subjects of system of blood performing procurement, conversion, testing, storage, distribution and realization of donor blood and components of blood, to requirements of proper production practice.";

Item 4 to add 3) with subitem 27-1 of the following content:

"27-11) performs functions of authorized body in the sphere of donorship of blood and components of blood, functioning of system of blood, namely:

performs licensing of economic activity of subjects of system of blood on procurement and testing of donor blood and components of blood, irrespective of their final appointment, to conversion, storage, distribution and realization of donor blood and the components of blood intended for transfusion, forming and maintaining the licensed register and licensed cases, control of observance by licensees of licensed conditions of implementation of the corresponding types of economic activity in the sphere of donorship of blood and components of blood, functioning of system of blood;

performs actions of the state supervision (control) of activities of subjects of system of blood, and also the subjects providing services in transfusion of components of blood for the purpose of check of observance by such subjects of requirements to implementation of the corresponding type of activity, safety and quality of donor blood and components of blood, haemo supervision, tracking and documentation of their activities;

provides carrying out sampling of donor blood and components of blood for check and research, studies any documents and records concerning the purposes of implementation of actions of the state supervision (control) in the sphere of donorship of blood and components of blood, functioning of system of blood;

performs planned, unplanned actions of the state supervision (control) of activities of the subjects of system of blood performing procurement, conversion, testing, storage, distribution and realization of donor blood and components of blood, its compliance to requirements of proper production practice;

obtains information on serious adverse cases, serious adverse reactions and on suspicions concerning such cases or reactions;

obtains from subjects of system of blood information on appointment of the responsible person providing observance by the subject of system of blood with requirements to functioning of quality control system and also the notification on delegation of functions of the responsible person to other face or permanent or temporary replacement for the responsible person;

takes measures to ensuring international cooperation and exchange of information with authorized bodies in the sphere of donorship of blood and components of blood, functioning of system of blood of other states;

participates in exchange of information in general system of the message on the serious adverse cases, serious adverse reactions connected with procurement, conversion, testing, storage and distribution of blood and components of the blood operating in the EU;".

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