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Pharmexcil urges members to ensure quality of drugs & medical devices exported to Kyrgyz without state registration
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Shardul Nautiyal, Mumbai
June 23 , 2023
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The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the members to take note of the communication from the Ministry of Kyrgyz Republic regarding assessment of quality of medicines and medical devices exported to Kyrgyz Republic without state registration.
Pharmexcil is in receipt of a communication from the Department of Commerce about the Ministry of Kyrgyz Republic on the matter. It has been urged to provide comments on the implication of the communication to Lakshmi Prasanna, director, regulatory affairs, at (regulatory@pharmexcil.com). The above order will be assigned to UA Sadykov, Deputy Minister of Health Ministry of Kyrgyz Republic for execution and control.
As per the communication order, “In order to implement Article 14 of the Law of the Kyrgyz Republic “On Circulation of Medicines” and the Decree of the Government of the Kyrgyz Republic”, it has been stated to ensure quality control of medicines and medical devices imported in the Kyrgyz Republic, in accordance with the established procedure.
Within the framework of the procedure, it is required to carry out a quality assessment based on applicant’s application with the attached normative document on quality (in case of absence in the database of the department of medicine and medical devices), standard samples (Pharmacopoeia or working samples, if required according to a regulatory document); required reagents (if required according to the regulatory document); Copies of the GMP Certificate; a document on quality of medical product issued by the manufacturer of the medicinal product (quality certificate/certificate of analysis (CoA)/ analytical passport/protocol of analysis/test report).
The communication order further states that if it is impossible to test certain quality indicators according to the regulatory document on quality, it is necessary to provide additional information about the confirmation of the quality of the claimed medicine. Based on the results of the quality assessment, ensure the issuance of certificate or a reasonable refusal to issue a certificate on quality of medical product or medical device within the prescribed period.
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