RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of October 23, 2019 No. 908

About approval of criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated and frequency of implementation of planned actions of the state supervision (control) by Public service for safety issues of foodstuff and consumer protection 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 field of economic activity" the Cabinet of Ministers of Ukraine decides:

Approve criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated and frequency of implementation of planned actions of the state supervision (control) by Public service for safety issues of foodstuff and consumer protection which are applied is determined.

Approved by the resolution of the Cabinet of Ministers of Ukraine of October 23, 2019 No. 908

Criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated and frequency of implementation of planned actions of the state supervision (control) by Public service for safety issues of foodstuff and consumer protection is determined

1. To criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated and frequency of implementation of planned actions of the state supervision (control) is determined by Gosprodpotrebsluzhboy, belong:

the number of violations of requirements of Licensed conditions of implementation of economic activity on production of the veterinary medicines approved by the resolution of the Cabinet of Ministers of Ukraine of October 3, 2018 No. 808 (The Official Bulletin of Ukraine, 2018, No. 80, Art. 2680) which happened from the date of receipt of the license, but no more than in two years preceding planning period;

availability of system of quality assurance of products which conforms to international standards.

2. Risks of approach of negative effects from implementation of economic activity are determined by production of veterinary medicines in appendix 1.

3. The list of criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated their indicators and the number of points are determined by each indicator in appendix 2.

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) of activities of subjects of managing for production of veterinary medicines are performed 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.

6. If by results of the last planned action of the state supervision (control) of the subjects of managing carried to average and insignificant risk degree fundamental breaches of requirements of the legislation for production of veterinary medicines are not revealed, the following planned event of the state supervision (control) concerning such subjects of managing is held not earlier than through the period of time established for the corresponding risk degree, increased twice.

Appendix 1

to Criteria by which the risk degree from implementation of economic activity on production of veterinary medicines is estimated and frequency of implementation of planned actions of the state supervision (control) by Public service for safety issues of foodstuff and consumer protection is determined

Risks of approach of negative effects from implementation of economic activity on production of veterinary medicines

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