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State Service of Ukraine on Medicines and Drugs Control Will Carry Inspections In 2018

26/ 02/ 2018
  The State Service of Ukraine on Medicines and Drugs Control will carry planned inspections for the implementation of state supervision (control) in 2018 in accordance with Resolution of the Cabinet of Ministers No. 1104 as of December 18th, 2017. According to the amendments to Article 2 of the Law of Ukraine On Temporary Features of the Implementation of State Supervision (Control) in the Commercial Area No. 1728-VIII as of November 3rd, 2016 (hereinafter - Law No. 1728-VIII), a moratorium on planned activities for the implementation of state supervision (control) in the commercial area was extended by December 31st, 2018. Let us remind you that state supervision (control) is the activity of authorized bodies to detect and prevent violations of the legislation by business entities and protect the interests of society, in particular, the proper quality of products, works and services, the permissible level of danger for the population, the natural environment. Supervision consists of planned and unscheduled activities such as audits, revisions, inspections, surveys and other forms determined by law. However, recently the Cabinet of Ministers of Ukraine approved a list of bodies that are not covered by the moratorium. The corresponding decision will come into force from the date of its official publication, which is planned in the near future. Meanwhile, its text can be found on the governments web portal. According to the specified list of bodies, the State Employment Service, the State Service of Ukraine for Food Safety and Consumer Protection, the State Fiscal Service and other state supervisory (control) authorities will carry inspections together with the State Service of Ukraine on Medicines and Drug Control. The annual implementation plan for the State Service of Ukraine on Medicines and Drug Control has been approved by the Order of November 2nd, 2017 and provides for inspection of compliance with licensing conditions and compliance with legislation on the quality of medicines, determines the subjects of management, the beginning and timing of activities for each of them. This plan, as well as other plans of the state supervision (control) authorities, must comply with the Plan of Comprehensive Measures of State Supervision (Control) Implementation for 2018 of the State Regulatory Service of Ukraine. In addition, the enterprise can find information on measures planned for it using the search form in the automated system of state supervision (control). Extra attention should be paid to the fact that the moratorium does not concern unplanned events, and Article 4 of Law No. 1728-VIII also specifies a list of cases for state supervision (control), for example, upon a court decision, in the event of a case that has an adverse material effect, etc.

The State Service of Ukraine on Medicines and Drugs Control will carry planned inspections for the implementation of state supervision (control) in 2018 in accordance with Resolution of the Cabinet of Ministers No. 1104 as of December 18th, 2017.

According to the amendments to Article 2 of the Law of Ukraine “On Temporary Features of the Implementation of State Supervision (Control) in the Commercial Area” No. 1728-VIII as of November 3rd, 2016 (hereinafter – Law No. 1728-VIII), a moratorium on planned activities for the implementation of state supervision (control) in the commercial area was extended by December 31st, 2018.

Let us remind you that state supervision (control) is the activity of authorized bodies to detect and prevent violations of the legislation by business entities and protect the interests of society, in particular, the proper quality of products, works and services, the permissible level of danger for the population, the natural environment. Supervision consists of planned and unscheduled activities such as audits, revisions, inspections, surveys and other forms determined by law.

However, recently the Cabinet of Ministers of Ukraine approved a list of bodies that are not covered by the moratorium. The corresponding decision will come into force from the date of its official publication, which is planned in the near future. Meanwhile, its text can be found on the government’s web portal.

According to the specified list of bodies, the State Employment Service, the State Service of Ukraine for Food Safety and Consumer Protection, the State Fiscal Service and other state supervisory (control) authorities will carry inspections together with the State Service of Ukraine on Medicines and Drug Control.

The annual implementation plan for the State Service of Ukraine on Medicines and Drug Control has been approved by the Order of November 2nd, 2017 and provides for inspection of compliance with licensing conditions and compliance with legislation on the quality of medicines, determines the subjects of management, the beginning and timing of activities for each of them. This plan, as well as other plans of the state supervision (control) authorities, must comply with the Plan of Comprehensive Measures of State Supervision (Control) Implementation for 2018 of the State Regulatory Service of Ukraine.

In addition, the enterprise can find information on measures planned for it using the search form in the automated system of state supervision (control).

Extra attention should be paid to the fact that the moratorium does not concern unplanned events, and Article 4 of Law No. 1728-VIII also specifies a list of cases for state supervision (control), for example, upon a court decision, in the event of a case that has an adverse material effect, etc.

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