Nurly-tau, 5 block, Almaty, Republic Kazakhstan.
Documents for submission
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Contract for examination of drugs, medical devices and MT for state registration, re-registration and amendments to the registration dossier
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Supplementary Agreement for examination of drugs for state registration, re-registration and amendments to the registration dossier
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Supplementary Agreement for examination to extend the contract.
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Supplementary Agreement for examination of medical devices and MT for state registration, re-registration and amendments to the registration dossier
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Letter form
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Power of attorney form
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Application for examination of drugs for state registration/re-registration
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Application for examination of drugs for amendments to the registration dossier
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The list of documents of registration dossier provided for state registration, re-registration of drugs
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The list of documents of registration dossier provided for state registration, re-registration of drugs in the Republic of Kazakhstan in the format of the Common Technical Document (for drugs produced under Good Manufacturing Practice)
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The list of documents for amendments
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Electronic format of documents
Initial examination
Initial examination of the drug includes:
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assessment of fullness, completeness and validity of the documents submitted of one set of registration dossier, which, after completion of the procedure of state registration, re-registrarion is transferred to the custody of the departmental archives;
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assessment of composition of the drug for the presence of prohibited dyes and other auxiliary substances, substances derived from human tissues and animal products, and, if available, the document confirming the safety of active substances of protein origin used in the manufacture of drugs (prion safety);
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assessment of the analytical part of registration dossier for compliance with regulatory and technical documents for the control of the quality and safety of drugs;
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check for drug samples, sufficient quantities and expiration date for analytical examination, availability of samples of medicinal substances, standard samples of drug substances and impurities, consumables (in exceptional cases and on the conditions of return) required for reproduction techniques for analytical examination of drug;
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analysis data on the pharmacological effect of the drug on its compliance with the code of the main pharmacological effects, anatomical therapeutic chemical classification (hereinafter - the ATC-classification);
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check for specifying the order of supply from drugstores (prescription or non-prescription), the completeness of the content of instructions for medicinal product application;
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verification of compliance of stated amendments to the registration dossier (amendments of type I or type II) and verification of guidance sections and pages of registration dossier, which must be amended;
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assessment of composition of the drug on the content of narcotic drugs, psychotropic substances and precursors.
Analytical expertise
Analytical expertise of the drug includes:
1) physical, chemical, physico-chemical and biological testing of drug samples for compliance with regulatory and technical documents for the control of the quality and safety of drugs;
2) assessment of regulatory and technical documents for the control of the quality and safety of drugs for the reproducibility of analysis techniques.
Specialty pharmaceutical expertise of the drug includes assessment of:
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Chemical safety and quality of drugs, the effects of the changes in the registration dossier for safety, efficacy and quality of drugs;
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Composition of drug and the conclusion of its rationality, the quality of drug substances and excipients;
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Production of drug (production formula, production technology, production process control, validation of manufacturing processes);
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Finished product (the compliance of parameters specified in the certificate of quality of the finished product with quality control methods described in the regulatory and technical documents for the control of the quality and safety of drugs, analysis of the report of the test laboratory, evaluation of the objectivity of reproduction and quality control methods, the adequacy of composition of drug and quality control methods);
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Conformity of quality specified in the regulatory and technical documents for the control of the quality and safety of drugs of the manufacturer, the State Pharmacopoeia of the Republic of Kazakhstan and international quality standards;
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Stability of drug, the validity of the claimed shelf-life, period of use after first opening the package or solution;
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Data on the chemical, pharmaceutical equivalence of drug;
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Labeling and packaging for their adequacy to ensure the preservation of the quality of drug during storage and transportation;
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Text instructions for medicinal product application, layout, packaging, labels for compliance with information on the conditions of storage, transportation, storage period, after the first period of application of the package is opened or dissolution, and adequate warnings;
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Composition of drug to belong to narcotic drugs, psychotropic substances and precursors, the ability or inability to retrieve easily accessible way of controlled substances in sufficient amounts to abuse in order to exclude the possibility of some control measures.
Specialty pharmaceutical expertise
Specialized pharmacological examination of registration dossier includes an analysis of administrative documents in Module 1 or Part 1, for data of preclinical (Module 4 or Part 3) and clinical (Module 5 or Part 4) research and instructions for medical use of drug.
Specialized pharmacological examination
Expert organization on the results of the primary, analytical and specialized pharmaceutical and pharmacological expertise of drug makes a report on the safety, efficacy and quality of drug.
Stage of concluding on the Safety
