Article 239. Examination of medicines and medical devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The examination of medicines and medical devices is a comprehensive assessment of safety, quality and effectiveness, benefit-risk ratio, evaluation of materials for clinical trials of medicines and medical devices, evaluation of optimal technical characteristics and clinical and technical justification of a medical device, carried out on the basis of materials from the registration dossier, laboratory tests for compliance with regulated quality, pharmacovigilance and safety monitoring data, the quality and effectiveness of medical products, materials for evaluating clinical trials, materials for evaluating optimal technical characteristics, and clinical and technical justification of a medical product.
2. The examination of medicines and medical products belongs to the state monopoly and is carried out by the state expert organization in the field of circulation of medicines and medical products.
Prices for goods (works, services) produced and/or sold by a state monopoly entity are set by the authorized body in coordination with the antimonopoly authority.
3. Requirements for the safety, quality and effectiveness of pharmaceutical substances (active pharmaceutical substances), medicinal raw materials, medicinal plant raw materials, bulk products of medicines or medical devices, original medicines, medicines of biological origin, biotechnological medicines, immunological medicines (immunobiological medicines), reproduced medicines (generics), homeopathic medicines, biosimilar medicines (biosimilars, biosimilar medicines, biosimilars) and medical products are presented during the examination of medicines and medical products in accordance with the procedure determined by the authorized body.
4. The grounds for a negative expert opinion on medicines and medical devices are:
1) failure to submit a complete set of registration dossier after issuing comments to the applicant during the examination within the time limits established in accordance with the procedure determined by the authorized body;
2) submission of false information by the applicant;
3) the ratio of the expected benefit to the possible risks associated with the use of the drug is not favorable;
4) lower quality and safety indicators regulated by the State Pharmacopoeia of the Republic of Kazakhstan or pharmacopoeias recognized as operating in the territory of the Republic of Kazakhstan, or in comparison with previously registered analogues;
5) the presence of substances and materials prohibited for use in the Republic of Kazakhstan in the composition of the medicinal product;
6) the presence of preservatives in the composition of solid dosage forms;
7) receiving negative results from one of the stages of the examination and (or) negative conclusions from experts of relevant organizations;
8) non-compliance of the actual production conditions and the quality assurance system with the conditions ensuring the declared safety, efficiency and quality, based on the results of the evaluation of the quality assurance system;
9) the applicant's refusal to organize a visit to the enterprise (production site) in order to assess the quality assurance system in accordance with the requirements of the legislation of the Republic of Kazakhstan;
10) identification of irrational combinations of medicines;
11) the applicant has not proven the clinical efficacy and safety of the medicinal product;
12) the quality of the medicinal product has not been confirmed;
13) a proven unfavorable benefit-risk ratio or an identified lack of therapeutic efficacy in compliance with the conditions of use of the medicinal product described in the approved general characteristics of the medicinal product during the post-marketing period;
14) facts established according to pharmacovigilance data indicating an unfavorable benefit-risk ratio of medicines, including an excess in the frequency of reporting adverse reactions compared with the data indicated in the approved general characteristics of the medicinal product;
15) inconsistency of the qualitative and quantitative composition of the drug with the declared one or repeated inconsistency of the quality of the medicinal product during its circulation on the market with the declared one at the time of its registration;
16) non-fulfillment by the holder of the registration certificate of obligations under pharmacovigilance;
17) the changes made have a negative impact on the benefit-risk ratio of the drug.
President
Republic of Kazakhstan
© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan
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