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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of June 5, 2019 No. 465

About approval of criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines and determine frequency of implementation of planned actions of the state supervision (control) by Public service for medicines and control of drugs

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

1. Approve criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines and frequency of implementation of planned actions of the state supervision (control) by Public service for medicines and control of drugs which are applied is determined.

2. Subitems 6 and 7 of Item 1, paragraphs of the fifth and sixth of Item 3 appendices to the resolution of the Cabinet of Ministers of Ukraine of September 10, 2008 No. 843 "About approval of criteria by which the risk degree from implementation of activities in the field of health care for safety of life and health of the population is estimated and is determined frequency of implementation of planned actions of the state supervision (control)" (2008, No. 72, the Art. 2427) to exclude the Official Bulletin of Ukraine.

Prime Minister of Ukraine

V. Groysman

Approved by the Resolution of the Cabinet of Ministers of Ukraine of June 5, 2019 No. 465

Criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines and determine frequency of implementation of planned actions of the state supervision (control) by Public service for medicines and control of drugs

1. Criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines and determine frequency of implementation of planned actions of the state supervision (control) by Gosleksluzhboy, are:

type of economic activity which is performed by the subject of managing in the field of production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients), in the field of quality control of medicines;

the number of pharmaceutical institutions at the subject of managing through which economic activity on wholesale and/or retail trade is performed by medicines;

type of medicines which production is performed by the subject of managing;

the system of the taxation applied by the subject of managing;

availability of quality management system of products conforming to standards;

availability of violations of requirements of the legislation in the field of production of the medicines (industrial) revealed by results of the previous action of the state supervision (control);

availability of violations of requirements of the legislation in the field of production (production) of medicines in the conditions of drugstore, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) revealed by results of the previous action of the state supervision (control);

availability of the decision on establishment of prohibition of the address of the medicine made or imported by the subject of managing, or availability of the negative conclusion about quality of the medicine imported into Ukraine issued within the last three years preceding planning period;

availability of case of involvement of officials of the subject of managing to the administrative responsibility for violation of requirements of the legislation in the field of quality control of medicines within the last three years preceding planning period.

2. Risks of approach of negative effects from implementation of economic activity in the field of production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines are determined in appendix 1.

3. The list of criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines, their indicators and the number of points is determined by each indicator in appendix 2.

4. According to the established criteria subjects of managing treat one of three risk degrees - high, to average or insignificant.

5. 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.

6. In case in activities of the subject of managing for one criterion it is possible to apply at the same time several indicators, the criterion indicator with the greatest number of points is chosen.

7. Planned actions of the state supervision (control) of activities of subjects of managing in the field of production of medicines, wholesale and retail trade by medicines, import of medicines (except active pharmaceutical ingredients), in the field of quality control of medicines are performed by Gosleksluzhboy with such frequency:

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

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

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

Appendix 1

to Criteria by which the risk degree from implementation of economic activity in the field of production of medicines is estimated of wholesale and retail trade medicines, import of medicines (except active pharmaceutical ingredients) and in the field of quality control of medicines and determine frequency of implementation of planned actions of the state supervision (control) by Public service for medicines and control of drugs

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