RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 13, 2019 No. 219

About approval of criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health and frequency of holding planned actions of the state supervision (control) by the specified Ministry is determined

According to part two of article 5 of the Law of Ukraine "About the basic principles of the state supervision (control) in the sphere of economic activity" the Cabinet of Ministers of Ukraine decides:

1. Approve criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health and frequency of holding planned actions of the state supervision (control) by the specified Ministry which are applied is determined.

2. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of February 11, 2016 "About approval of criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health and is determined No. 69 frequency of implementation by the specified Ministry of planned actions of the state supervision (control)" (The Official Bulletin of Ukraine, 2016, No. 16, the Art. 638);

Item of 33 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of December 18, 2017 No. 1103 (The Official Bulletin of Ukraine, 2018, No. 17, the Art. 573).

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 13, 2019 No. 219

Criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health and frequency of holding planned actions of the state supervision (control) by the specified Ministry is determined

1. Criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health and determine frequency of holding planned actions of the state supervision (control) by the specified Ministry, are:

the term of implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health;

observance by licensees of requirements of Licensed conditions of implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health;

the number of the unplanned events of the state supervision (control) held concerning the subject of managing during the last two - five years preceding planning period on the bases provided by paragraphs to the third, fifth , seventh, ninth part one of article 6 of the Law of Ukraine "About the basic principles of the state supervision (control) in the sphere of economic activity";

types of fabrics and cells of the person with which activities of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health and the purpose of their use are resolved.

2. The form according to appendix 1 is applied to risk identification of approach of negative consequences from implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health.

3. For determination of the list of criteria by which the risk degree from implementation of economic activity of banks of umbilical blood is estimated of other tissues and cells of the person according to the list approved by the Ministry of Health, their indicators, the number of points on each indicator, scales of points and frequency of holding planned actions of the state supervision (control) the form according to appendix 2 is applied.

4. Reference of the subject of managing to high, average or insignificant risk degree is performed taking into account score, added by all criteria determined in appendix 2, by the following scale:

from 41 to 100 points - to high risk;

from 21 to 40 points - to average risk degree;

from 0 to 20 points - to insignificant risk degree.

5. Planned actions of the state supervision (control) in field of activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health are performed behind activities of subjects of managing which are referred to:

high risk - is not more often than once in two years;

average risk degree - is not more often than once in three years;

insignificant risk degree - is not more often than once in five years.

6. If by results of at least two last planned actions of the state supervision (control) the facts of violation of requirements of the legislation in field of activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health are not elicited, the following planned event of the state supervision (control) concerning such subject of managing is held not earlier than through the period established for the corresponding risk degree increased in time 1,5. The specified provision is not applied to the subjects of managing carried to high risk.

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