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Registration of a skin antiseptic in 10 days
In the context of COVID-19 coronavirus infection outbreak and the announcement of «internationally important emergency situation in the field of public healthcare» as well as the state of emergency, the Ministry of Health of the Republic of Kazakhstan has developed a procedure for accelerated preauthorization expert examination of skin antiseptics and disinfectants, which includes:
· Accelerated preauthorization expert examination of disinfectants (skin antiseptics) under formulation recommended by WHO:
1) Carrying out laboratory tests to validate the chemical composition of skin antiseptics - 1-3 days.
2) Analysis of international data and scientific literature on the efficacy and toxicity of skin antiseptics of similar formulation - 1-2 days.
3) The issuance of research reports, expert opinion and chemical composition test report - 1 day.
· Accelerated preauthorization expert examination of disinfectants (skin antiseptics) under manufacturer's formulation as well as other disinfecting products:
1) Carrying out laboratory tests to validate claimed specifications of disinfectants (25 days)
2) Analysis of test results in accordance with international data and scientific literature - 1-2 days.
3) The issuance of research reports, expert opinion and chemical composition test report - 1 day.
The applicant/manufacturer shall, for preauthorization expert examination to be conducted, provide:
· copies of the documents under which the products are manufactured (standard, in-house standard, specifications) (one of the documents listed shall be provided), processing instruction, formulation certified by the manufacturer (producer);
· a written notice of the manufacturer (producer) that the product manufactured meets the requirements set out in the respective production documents. The following documents may be used as a notice: copies of the quality certificate, safety (quality) data sheets, certificates of quality certified by the manufacturer (producer), or the manufacturer's letter (one of the documents listed shall be provided);
· manufacturer's (producer's) documentation on the application (operation, use) of products (instructions, guidelines, recommendations) (one of the documents listed above) or a copy thereof certified by the applicant;
· a copy of the label (packaging) and their mock-ups for products certified by the applicant;
· a certificate of sampling issued by the laboratories (centers) accredited (certified) under national systems of accreditation (certification) and incorporated in the Unified Register of Certification Bodies and Testing Laboratories (Centers) of the Customs Union.
This service is exclusively available for Kazakhstan-based manufacturers of disinfectants. The State Registration (Marketing Authorization) Certificate is valid for the entire EEU.
Currently, this project has been approved and signed by the Ministry of Health of the Republic of Kazakhstan.
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