Pharmacovigilance is a type of activity related to the definition, collection, assessment, study and prevention of adverse reactions (hereinafter referred to as AR) or other issues related to the safety and effectiveness of the use of medicines and medical devices.
Blitz Medica LLP represents the interests of foreign companies (manufacturers) in the territory of the Republic of Kazakhstan as an authorized representative, as well as an authorized person for monitoring adverse events in the territory of the Republic of Kazakhstan.
Pharmacovigilance in Kazakhstan: monitoring and assessment of the safety of medicines and medical devices in the Republic of Kazakhstan
The quality assessment of medicines and medical devices registered in the Republic of Kazakhstan is carried out by determining the compliance of the quality of medicines and medical devices with the data of the registration dossier, regulatory documents on the quality of medicines, on the basis of which they were registered in the Republic of Kazakhstan and is carried out in accordance with the requirements of the Rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan, approved by the order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. ҚР ДСМ-282/2020.
In accordance with paragraph 2 of Article 241 of the Code of the Republic of Kazakhstan «On Public Health and the Healthcare System», the quality assessment of medicines and medical devices registered in the Republic of Kazakhstan belongs to the state monopoly and is carried out by the state expert organization in the field of circulation of medicines and medical devices — RSE on the Right of Economic Management «National Center for Expertise of Medicines and Medical Devices» of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan.
Product quality assessment is carried out for the purpose of:
- determining the quality of registered products
- determining the quality of products selected from the market taking into account the risk-oriented approach
- preventing the circulation of counterfeit products on the market of the Republic of Kazakhstan.
Product quality assessment includes conducting an examination of documents when declaring products and conducting laboratory tests of product samples selected from the market taking into account the risk-oriented approach during the validity period of the product conformity certificate.
Quality assessment is carried out for each series (batch) of products manufactured and imported to the Republic of Kazakhstan during the validity period of the registration certificate, including those registered in accordance with the Rules for the Registration and Expertise of Medicines for Medical Use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 and the Rules for the Registration and Expertise of the Safety, Quality and Efficiency of Medical Devices, approved by the decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46.
During the validity period of the product conformity certificate, the expert organization conducts laboratory tests of product samples selected from the market taking into account the risk-oriented approach.
To conduct laboratory tests of product samples in circulation on the territory of the Republic of Kazakhstan, the expert organization annually develops a schedule for the selection of product samples and agrees it with the manufacturer or holder of the registration certificate of the medicinal product (authorized representative of the manufacturer of the medical device) or their authorized representatives (hereinafter referred to as the manufacturer).
Sampling of products in circulation in the territory of the Republic of Kazakhstan is carried out by an expert organization in accordance with the procedure established by subparagraph 20) of Article 10 of the Code.
Testing is carried out at the expense of the manufacturer in accordance with the established prices for services sold by the state monopoly entity, approved in accordance with the second paragraph of paragraph 2 of Article 241 of the Code.
Reimbursement of the cost of product samples selected for testing to the entity from which the selection was carried out is carried out by the manufacturer in the multiple of the sample selection performed, depending on the number of entities (objects) of sampling locations (by region, by the number of distributors, pharmacies and medical organizations).
Testing of product samples is carried out in testing laboratories of the expert organization accredited in the manner prescribed by paragraph 6 of Article 25 of the Code.
To conduct tests of selected samples of products from the market and/or in medical organizations, the manufacturer provides standard samples of chemicals, standard samples of biological preparations, specific reagents, test strains of microorganisms, cell cultures if necessary and on a return basis, if applicable, consumables used in testing of drugs and sterile medical products, with the exception of medical equipment in quantities sufficient for a single test with a residual shelf life of at least six months.
