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Features of the user testing procedure for the package insert in Kazakhstan In the procedure for registration of medicinal products in accordance with the EAEU rules, one of the requirements is to conduct user testing of the package leaflet (PL) in the national language in the Union country. As a rule, in the EAEU countries, the results of user testing (UT) are provided for the draft package leaflet, which in the event of adjustment of the package leaflet by the expert organization may lead to the need for repeated user testing. The provision of user testing results in Kazakhstan is carried out according to a different algorithm — testing is carried out after the approval of the final version of the package leaflet according to the scheme below. This allows you to avoid additional costs for repeated testing, and in some cases reduce the overall time of the registration process. 90 working days are given for the approval and execution of user testing, provided in response to the expert’s request in XML format in the form of a response to the expert’s request.

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.

Obtaining official confirmation of the need/absence of need for state registration of medical devices and medicines Obtaining a duplicate registration certificate from the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan Registration of a trademark (brand) in the territory of the Republic of Kazakhstan

Assessment of the quality of medicines and medical devices In order to sell medicines and medical devices in the territory of Kazakhstan, in addition to the registration of medicines and medical devices, the quality assessment of medicines and medical devices is a mandatory procedure. Quality assessment is carried out in order to prevent the sale of low-quality, potentially dangerous and counterfeit products in the country that may harm consumers. 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 conducting quality assessment of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. ҚР ДСМ-282/2020. The assessment of the quality and safety of medicines in Kazakhstan and the EAEU (Eurasian Economic Union) is carried out with the aim 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. How is certification and assessment of the quality and safety of medicines carried out in the Republic of Kazakhstan and the EAEU: Russia, Belarus, Kyrgyzstan and Armenia Product quality assessment includes examination of documents when declaring products and laboratory testing 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. The expert organization, within five working days from the date of receipt of the application, checks the submitted documents and verifies the data specified in them with the information provided in the State Register of Medicines and Medical Devices. When organizing and conducting sanitary and anti-epidemic and sanitary and preventive measures and related restrictive measures, including quarantine, product quality assessment is carried out using an accelerated procedure within a period of no more than three working days from the date of receipt of the application. In the event of an incomplete package of documents stipulated by paragraphs 7, 8 of the Rules, or provision of inaccurate information, the expert organization sends the applicant a notification via the information system about the elimination of the relevant comments. The applicant, within a period of no more than five working days from the date of receipt of the notification, which is not included in the general period for conducting the quality assessment of medicines and medical devices, eliminates the relevant comments. Based on the results of the examination of documents, in the absence of comments, the expert organization draws up and registers in the information system of the expert organization a certificate of conformity for the product in the form according to Appendix 2 to the Rules. When specifying a specific product covered by the certificate of conformity for the product, an appendix to the certificate of conformity for the product is additionally drawn up in the form according to Appendix 3 to these Rules. The certificate of conformity for the product is issued in electronic format via the information system of the expert organization. Validity of certification and quality assessment of medicines in the Republic of Kazakhstan and the EAEU The validity period of the product certificate of conformity is set until the end of the shelf life (operation period) of the product, while the shelf life (operation period) is determined until the last day of the specified month (for medical equipment in accordance with the technical passport) inclusive. Cost and prices for certification services and quality assessment of medicines (drugs) in the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan – the EAEU countries If you need to conduct a quality assessment of medicines or medical devices, our team will be happy to help you collect the necessary package of documents and submit an application. To date, the Blitz Medica team has conducted more than 69 production assessments. Our specialists will consult you and help you obtain a certificate of conformity for your products.

Blitz Medica LLP offers a «turnkey project» for registration, which will include all possible expenses, including examination, state fee, translations, notarization, production assessment, etc. The «one-stop shop» principle for the convenience of our Partners.

Assessment of the quality of medicines and medical devices In order to sell medicines and medical devices in the territory of Kazakhstan, in addition to the registration of medicines and medical devices, the quality assessment of medicines and medical devices is a mandatory procedure. Quality assessment is carried out in order to prevent the sale of low-quality, potentially dangerous and counterfeit products in the country that may harm consumers. 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 conducting quality assessment of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. ҚР ДСМ-282/2020. The assessment of the quality and safety of medical devices in Kazakhstan and the EAEU (Eurasian Economic Union) is carried out with the aim 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. How certification and assessment of the quality and safety of medical devices are carried out in the Republic of Kazakhstan and the EAEU: Russia, Belarus, Kyrgyzstan and Armenia Product quality assessment includes examination of documents when declaring products and laboratory testing 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. The expert organization, within five working days from the date of receipt of the application, checks the submitted documents and verifies the data specified in them with the information provided in the State Register of Medicines and Medical Devices. When organizing and conducting sanitary and anti-epidemic and sanitary and preventive measures and related restrictive measures, including quarantine, product quality assessment is carried out using an accelerated procedure within a period of no more than three working days from the date of receipt of the application. In the event of an incomplete package of documents stipulated by paragraphs 7, 8 of the Rules, or provision of inaccurate information, the expert organization sends the applicant a notification via the information system about the elimination of the relevant comments. The applicant, within a period of no more than five working days from the date of receipt of the notification, which is not included in the general period for conducting the quality assessment of medicines and medical devices, eliminates the relevant comments. Based on the results of the examination of documents, in the absence of comments, the expert organization draws up and registers in the information system of the expert organization a certificate of conformity for the product in the form according to Appendix 2 to the Rules. When specifying a specific product covered by the certificate of conformity for the product, an appendix to the certificate of conformity for the product is additionally drawn up in the form according to Appendix 3 to these Rules. The certificate of conformity for the product is issued in electronic format via the information system of the expert organization. Validity of certification and quality assessment of medical devices in the Republic of Kazakhstan and the EAEU The validity period of the product conformity certificate is set until the end of the shelf life (operation period) of the product, while the shelf life (operation period) is determined until the last day of the specified month (for medical equipment in accordance with the technical passport) inclusive. Cost and prices for certification services and quality assessment of medical devices in the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan – the EAEU countries If you need to conduct a quality assessment of medicines or medical devices, our team will be happy to help you collect the necessary package of documents and submit an application. To date, the Blitz Medica team has conducted more than 69 production assessments. Our specialists will consult you and help you obtain a certificate of conformity for your products.

Development of analytical regulatory documentation and instructions Development of a list of changes when registering medicines Development of instructions for use when registering medicines

Obtaining a license for medical activity in the Republic of Kazakhstan Blitz Medica LLP will undertake the entire procedure for collecting the necessary documents, preparing the necessary conditions and accompanying the Client to the authorized bodies to obtain the following types of licenses: License for import of ionizing radiation sources License for import of products subject to export control License for medical activities License for pharmaceutical activity Notification of the beginning/termination of wholesale and retail sales of medical devices     On October 6, a conference call was held in Kazakhstan under the chairmanship of Prime Minister of the Republic of Kazakhstan Askar Mamin. The meeting reviewed the Comprehensive Plan for the Development of the Pharmaceutical and Medical Industry (hereinafter referred to as the «Plan»), reports the website primeminister.kz In 2020, due to the coronavirus pandemic, pharmaceutical activity showed growth, while many types of businesses lost income, and some closed altogether. The share of domestic companies in the purchase of medicines and medical devices has grown to 30%, and the growth trend will continue in the future. In this regard, many entrepreneurs are considering the possibility of working in the pharmaceutical and healthcare sector. A little about the process of licensing pharmaceutical activities in the Republic of Kazakhstan: Pharmaceutical activities include the production and manufacture of medicines, the production and manufacture of medical devices. An application for a license for pharmaceutical or medical activities is submitted on the electronic portal elicense.kz The term for obtaining a license is 15 calendar days. During this time, KKKBTU experts check the authenticity of the documents and visit the site. In order to engage in pharmaceutical and medical activities in the Republic of Kazakhstan, a license is required. Obtaining a license for pharmaceutical or medical activities is not an easy process. If you are interested in obtaining a license for pharmaceutical or medical activities, then the company Blitz Medica LLP will take on the entire procedure for collecting the necessary documents, organizing appropriate conditions and accompanying the Client in authorized bodies. The Blitz Medica team has experience in successfully obtaining a license for pharmaceutical activities. We also recently successfully completed a project to obtain a license to import ionizing radiation sources.

Blitz Medica experts have extensive experience in collecting registration dossiers and can convert any document format into XML. In the process of translating the dossier, we also identify errors, which minimizes the risks of returning the dossier and saves time. We use only official software and monitor the relevance of updates, due to which we comply with all the rules of the EAEU. With the update of the registration procedure for medical devices and drugs, the submission of a dossier for expert work will be carried out through a file converted to XML format in accordance with the «Rules for the registration and examination of drugs for medical use», approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated 03.11.2016 and in accordance with Decision No. 46 dated 12.02.2016 «On the Rules for the registration and examination of the safety, quality and effectiveness of medical devices». According to the standard «Extensible Markup Language (XML) 1.0 (Fifth Edition)» Difficulties that may be encountered when converting a dossier to XLM format: A large number of rules and a complex structure of the electronic format Availability of documents in PDF format and their correct opening (availability of a text layer) Correct entry of information and registry sensitivity Compliance with maximum permissible documentation sizes Benefits of working with us: Successful submission of the dossier to the NCEL, due to precise compliance with the regulatory and legal acts of the EAEU Saving time Full support and consulting assistance Fair price Our company Blitz Medica will completely take over the process of forming or converting a dossier into XML format.

Obtaining a license for pharmaceutical activities in the Republic of Kazakhstan Blitz Medica LLP will take over the entire procedure for collecting the necessary documents, preparing the necessary conditions and accompanying the Client to the authorized authorities to obtain the following types of licenses: License for import of ionizing radiation sources License for import of products subject to export control License for medical activities License for pharmaceutical activity Notification of the beginning/termination of wholesale and retail sales of medical devices License for maintenance, installation, dismantling, charging, recharging, repair of devices and installations, including medical ones, containing radioisotope sources of ionizing radiation or generating ionizing radiation Obtaining a SES conclusion for production facilities On October 6, a conference call was held in Kazakhstan under the chairmanship of Prime Minister of the Republic of Kazakhstan Askar Mamin. The meeting reviewed the Comprehensive Plan for the Development of the Pharmaceutical and Medical Industry (hereinafter referred to as the «Plan»), the website primeminister.kz reports In 2020, due to the coronavirus pandemic, pharmaceutical activity showed growth, while many types of businesses lost income, and some closed altogether. The share of domestic companies in the purchase of medicines and medical devices has grown to 30%, and the growth trend will continue in the future. In this regard, many entrepreneurs are considering the possibility of working in the pharmaceutical and healthcare sector. A little about the process of licensing pharmaceutical activities in the Republic of Kazakhstan: Pharmaceutical activities include the production and manufacture of medicines, the production and manufacture of medical devices. An application for a license for pharmaceutical or medical activities is submitted on the electronic portal elicense.kz The term for obtaining a license is 15 calendar days. During this time, KKKBTU experts check the authenticity of the documents and visit the site. In order to engage in pharmaceutical and medical activities in the Republic of Kazakhstan, a license is required. Obtaining a license for pharmaceutical or medical activities is not an easy process. If you are interested in obtaining a license for pharmaceutical or medical activities, then the company Blitz Medica LLP will take on the entire procedure for collecting the necessary documents, organizing appropriate conditions and accompanying the Client in authorized bodies. The Blitz Medica team has experience in successfully obtaining a license for pharmaceutical activities. We also recently successfully completed a project to obtain a license to import ionizing radiation sources.