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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of May 30, 2024 No. 621

About approval of Licensed conditions of implementation of economic activity on procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion

According to Item and paragraph one of part two of article 9 of the Law of Ukraine "About licensing of types of economic activity" the Cabinet of Ministers of Ukraine decides 34 parts one of Article 7:

1. Approve Licensed conditions of implementation of economic activity on procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion (further - Licensed conditions) which are applied.

2. Determine that the subjects of managing who obtained till January 1, 2027 the license for implementation of economic activity on procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion shall submit till February 1, 2027 to body of licensing the document provided by the subitem 6 of Item 6 of Licensed conditions.

3. This resolution becomes effective in one year from the date of its publication, except the subitem 6 of Item 6, of the subitem 4 of Item 15 of the Licensed conditions which are becoming effective since January 1, 2027.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of May 30, 2024 No. 621

Licensed conditions implementation of economic activity on procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion

General part

1. These Licensed conditions determine the exhaustive list of the requirements obligatory for accomplishment by the licensee, and also the exhaustive list of the documents enclosed to the application for receipt of the license for implementation of economic activity on procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion (further - the license).

The licensee shall fulfill requirements of these licensed conditions, and the license applicant - it to answer.

2. Action of these Licensed conditions extends to all subjects of managing performing activities for procurement and testing of donor blood and components of blood irrespective of their final purpose, conversion, storage, distribution and realization of donor blood and components of blood intended for transfusion (further - economic activity).

3. Action of these Licensed conditions does not extend to the healthcare institutions providing services in transfusion of blood and/or components of blood.

4. In these Licensed conditions terms are used in the value given in the Laws of Ukraine "About licensing of types of economic activity", "About safety and quality of donor blood and components of blood", Bases of the legislation of Ukraine on health protection.

5. The license applicant for its obtaining submits the method provided by part one of article 10 of the Law of Ukraine "About licensing of types of economic activity" to body of licensing the statement in form according to appendix 1.

6. To the statement, except documents, the stipulated in Article 11 Laws of Ukraine "About licensing of types of economic activity", are attached:

1) the file of the subject of system of blood concerning each place of implementation of economic activity according to the requirements specified in appendix 2;

2) information on confirmation of lack of control of activities of the subject of managing in the value given in article 1 of the Law of Ukraine "About protection of the economic competition", residents of the states performing the armed aggression against Ukraine in the value given in article 1 of the Law of Ukraine "About defense of Ukraine". Such information moves in any form;

3) data on availability of places of implementation of economic activity to handicapped national groups according to appendix 3;

4) the description of the documents enclosed to the application for receipt of the license in form according to appendix 4 in duplicate (in case of submission of documents in paper form);

5) copy of the certificate of conformity to requirements of DSTU ISO 9001:2015 (ISO 9001:2015, IDT) "Quality management systems. Requirements" or DSTU EN ISO 9001:2018 (EN ISO 9001:2015, IDT; ISO 9001: 2015, IDT) "Quality management systems. Demand";

6) the copy of the certificate about accreditation according to requirements of DSTU EN ISO 15189:2015 "Medical laboratories. Quality requirement and competence".

7. Consideration of the application about receipt of the license is performed by body of licensing according to the procedure and the terms determined by the Law of Ukraine "About licensing of types of economic activity".

8. The documents submitted to body of licensing are constituted by the license applicant, the licensee according to the Law of Ukraine "About licensing of types of economic activity".

9. In case of change of data which are specified in the documents which are enclosed to the application for receipt of the license, in particular rather new place of implementation of economic activity the licensee submits to body of licensing the notification on changes of data on form according to appendix 5 and the documents determined in Item of 6 presents of Licensed conditions, by description according to appendix 4.

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