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GMP Legal Framework in Kyrgyzstan

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1 GMP Legal Framework in Kyrgyzstan
SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center IV ALL-RUSSIA GMP CONFERENCE GMP Legal Framework in Kyrgyzstan I.U. Toktonaliev is a leading specialist for Good Pharmaceutical Practices Division, Department of Drug Supply and Medical Technology under the Ministry of Health of the Kyrgyz Republic

2 State registration of DP and MD; Pharmaceutical inspection;
The state regulation of relations arising in the field of circulation of medicines is carried out by the Government of the Kyrgyz Republic and the authorized state body of the Kyrgyz Republic in the field of healthcare, i.e. the Ministry of Health of the Kyrgyz Republic, (Law of the Kyrgyz Republic “On Circulation of Medicines” No. 165 dated August 2, 2017). The main task of the Department of Drug Supply and Medical Technology under the Ministry of Health of the Kyrgyz Republic is the REGULATION of the CIRCULATION of DP and MD: (Decree of the Government of the Kyrgyz Republic dated September 26, 1997 No. 556) State registration of DP and MD; Pharmaceutical inspection; State control and supervision; Assessment of the quality of imported and manufactured DP and MD General partner: Strategic partners: Official partners: Regional partners:

3 Establishment of a pharmaceutical inspectorate
Section 15. Pharmaceutical Inspection “The authorized state body of the Kyrgyz Republic in the field of healthcare conducts a pharmaceutical inspection in order to assess the activities of pharmaceutical entities for compliance with good pharmaceutical practices, as well as to monitor and supervise compliance with requirements in the field of drug circulation” (Law of the Kyrgyz Republic No. 165 dated August 2, 2017) . Office for Good Pharmaceutical Practices of the Department of Drug Supply and Medical Technology (Order of the Minister of Health of the Kyrgyz Republic dated November 14, 2018 No. 769) The main functions of the office: conducting an inspection of compliance with the requirements of Good Manufacturing Practice; interaction with the inspectorates of the EAEU member states; participation in the work of the EAEU working group on pharmaceutical inspections; development, implementation and improvement of the quality system of the pharmaceutical sector; development of draft regulatory documents in the field of good pharmaceutical practices; maintaining a register of conducted pharmaceutical inspections; maintaining a register of pharmaceutical inspectors and submitting information to the Unified Register of Pharmaceutical Inspectors of the EAEU. General partner: Strategic partners: Official partners: Regional partners:

4 The following activities are currently carried out:
As part of the WHO benchmarking of NRAs, a general quality management system of Department of Drug Supply and Medical Technology covering the quality system of the pharmaceutical inspectorate of the Kyrgyz Republic is being developed . Training and continuing education of pharmaceutical inspectors Draft laws and regulations are developed: On the implementation of the EAEU's Good Pharmaceutical Practices; Approval of the rules for conducting pharmaceutical inspections of compliance with the requirements of the rules of good pharmaceutical practices. General partner: Strategic partners: Official partners: Regional partners:


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