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On July 1, 2012, the Technical Regulation of the Customs Union “On the Safety of Perfume and Cosmetic Products“ came into force, approved by the Decision of the Commission of the Customs Union from September 23, No. 799. According to the abovementioned Technical Regulation, perfume and cosmetic products are issued in circulation on the market in accordance with TR of CU 009/2011, as well as other technical regulations of CU, the requirements for which are applicable to it. Perfume and cosmetics products that meet the requirements of the abovementioned technical regulations should be marked with a single product circulation mark in the market of the Customs Union member states. Blitz Medica LLP will register or declare perfume and cosmetic products in accordance with all requirements and rules of this regulation. The safety of perfume and cosmetic products is ensured by a set of requirements for: ✓ composition ✓ physicochemical parameters ✓ microbiological parameters ✓ content of toxic elements ✓ toxicological parameters ✓ clinical (clinical laboratory) indicators ✓ production ✓ consumer packaging ✓ product labeling List of perfume and cosmetic products subject to the state registration: ✓ Perfume and cosmetic products for artificial tan ✓ Perfume and cosmetic products for artificial tan for bleaching (brightening) the skin ✓ Cosmetics for permanent makeup ✓ Intimate cosmetics ✓ Perfume and cosmetic products of individual skin protection from harmful production factors ✓ Baby cosmetics ✓ Perfume and cosmetic products for chemical coloring, lightening and highlight ✓ Perfume and cosmetic products for для perming and straightening hair ✓ Perfume and cosmetic products, produced using nanomaterials ✓ Perfume and cosmetic products for depilation ✓ Peelings ✓ Fluorine-containing hygiene products of the oral cavity, the mass fraction of fluorides in which exceeds 0.15% (for liquid products of the oral cavity — 0.05%) ✓ Products for teeth whitening containing hydrogen peroxide or other components releasing hydrogen peroxide, including carbamide peroxide and zinc peroxide, with a concentration of hydrogen peroxide (as an ingredient or excreted), 0.1% to 6.0% of hydrogen peroxide, including carbamide peroxide and zinc peroxide, with concentration The Declaration of Conformity of Perfumes and Cosmetic Products with the Technical Regulationsof the Customs Union and the Certificate of State Registration of Products is drawn up for one or several names of products of the same name and is valid until changes in the name of the product and/or in the recipe of products leading to changes in safety indicators.

Registration of medical devices and medical equipment in Kazakhstan and the EAEU countries State registration of medical devices and medical equipment is a mandatory procedure in Kazakhstan for a larger type of medical devices. The registration procedure is not easy, we are ready to help you to receive registration certificate as soon as possible and take care of paperwork and all process. Blitz Medica provides registration and market access consultancy services, we guarantee the high-quality performance of all services provided by company. You can see our partner’s reviews on corporate website: https://eng.blitzmed.com/responses/. Blitz Medica company has registered more than three hundred eighteen types of different medical devices and medical equipment, including: Medical masks; Personal protective equipment; Implants and abutments; Dialyzers and lines; Catheters Coronary catheter; Coils for embolization and cerebral aneurysms; Stentriver for the removal of blood clots; A set of devices and instruments for endoscopic operations and diagnostic studies of NAIEOD; Neurosurgical system; Articulating clipper; Circular disposable stapler; Dry concentrates for hemodialysis; Syringes are medical; Apparatus for hemodialysis; Patient monitor; Anesthetic and respiratory apparatus; Dental alloys; Disposable lancets and more; dental instruments; dental materials; gynecological equipment; surgical equipment; surgical instruments; artificial lung ventilation apparatus (IVL); patient monitor; defibrillator; neurosurgical system; MRI apparatus; equipment of the endoscopic series; ultrasound machine; blood pressure monitoring system; computed tomography equipment; diagnostic complex; endosurgical complex. Cost and prices for registration and re-registration services of Medical Devices and Medical Equipment in Kazakhstan and in Eurasian Economic Union | EAEU Registration of medical devices according Eurasian Economic Union rules launched in 2017 and has a lot of real advantages, the first of all you save your time registering your medical product in EAEU and you do not need to register device in every country separately. It means you have less paperwork to do, less human resources to receive a permission to distribute your product in different countries. Order registration service of Medical Devices and Medical Equipment in Kazakhstan and in Eurasian Economic Union For consultation and ordering the service please call +7 708 983 28 18. 2021 © Registration of Medical Devices and Medical Equipment in Kazakhstan and the EAEU — Re-registration and accelerated registration of Medical Devices and Medical Equipment in the Eurasian Economic Union — Blitzmed.com

✓ Obtaining official confirmation of the need/absence of the need for state registration of a medical device and drug products. ✓ 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.

Blitz Medica LLP offers a turnkey project for registration, which will include all possible costs, including examination, state charge, transfers, notarial certification, production assessment, etc. One window principle for the convenience of our Partners.

This service is provided in cases when the Customer needs to make (one-time) import of (un) registered medical device into the Republic of Kazakhstan. In the course of solving this task Blitz Medica selects the best variant of import in accordance with the Order No. 711. The service is completed by issuing an official permit from the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan.

The team of translators of Blitz Medica LLP, made up of specialists with extensive experience in working with technical and medical documentation, will help in qualitatively and in a short time translate all the required volume when forming the dossier and passing the examination.

Blitz Medica LLP undertakes the collection, processing and preparation of advertising materials, as well as accompanies this process in the Republican State Enterprise on the right of economic management “National Center of Expertise of drug products, medical devices and medical equipment” before issuing a favorable conclusion. An obligatory condition for issuing permission to advertise drug products, medical devices and medical equipment is the preliminary examination of the advertising material in the state expert organization. The permission for advertising is issued for the period of validity of the registration certificate of drug products, medical devices and medical equipment in accordance with Annex 2 to the Standard of State Service “Issuance of permission for advertising of drug products, medical devices and medical equipment” approved by the Resolution of the Government of the Republic of Kazakhstan dated October, 8, 2012 No. 1262. The advertised properties and characteristics of drug products, medical devices and medical equipment, regardless of the type of advertising, must comply with the instructions for medical use approved by the authorized body at state registration, the operational document for medical equipment. Drug products, medical devices and medical equipment distributed as advertising samples must be registered in the Republic of Kazakhstan and be accompanied by instructions for medical use, the operational document (for medical equipment).

Our company provides marketing research services using extensive data collection resources to implement plans of concerned parties (foreign investor, domestic distributor, dealer) who want to become a participant in the medical market of the Republic of Kazakhstan. This work will include information on analogues and competitors, prices, retail and wholesale sales, tenders conducted over the past 3-5 years to identify the prospects and risks of implementing a particular product. The integrated stages of the market analysis are as follows: ✓ Analysis of the size, dynamics and potential of the market development ✓ Market trend research, market segmentation and the identification of key segments ✓ Competitive market analysis ✓ Price analysis and general economic market analysis ✓ Analysis of the structure of distribution of goods on the market ✓ Analysis of advertising methods, methods of promotion and support of goods on the market ✓ Analysis of demand, key needs and characteristics of buyers’ behavior in the market ✓ Identification of the main market and consumer trends

Pharmacovigilance is a type of activity related to the definition, collection, evaluation, study and prevention of the occurrence of adverse reactions (hereinafter — AR) or other issues related to the safety and efficacy of the application (use) of medicines and medical devices. Blitz Medica LLP represents the interests of foreign companies (manufacturers) in the Republic of Kazakhstan in the form of an authorized representative, as well as an authorized person to monitor adverse events in the territory of the Republic of Kazakhstan.

Blitz Medica LLP will take over the entire procedure for collecting the necessary documents, preparing the necessary conditions and supporting the Customer in the authorized bodies, to obtain the following types of licenses: ✓ Granting the license to import sources of ionizing radiation ✓ Granting the license to import products subject to export control ✓ Granting the license for medical activities ✓ Granting the license for pharmaceutical activities ✓ Granting the 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

This item of the services of Blitz Medica LLP includes several procedures performed in the field of metrology. ✓ Receiving an official letter from KazInMetr about the need to inscribe in the SI Register ✓ Receiving an official letter from KazInMetr about the absence to inscribe in SI Register ✓ The procedure for expertise of the product, its entry into SI Register and issuance of the certificate ✓ The procedure for the recognition of SI certificate of EEU countries ✓ Verification of equipment entered in SI register

This group of services includes: ✓ Evaluation of the safety and quality of drug products and medical products carried out through the Republican State Enterprise on the right of economic management “National Center of Expertise of drug products, medical devices and medical equipment of the Ministry of Health of the Republic of Kazakhstan 1) Evaluation of the safety and quality of the serial evaluation of the safety and quality of drug products that have GMP conformity certificates, medical devices that have certificates of compliance with the quality management system requirements for the manufacture of medical devices ISO 13485, GMP; 2) Evaluation of the safety and quality of each lot (batch) of products. In the case of continuous production, the lot corresponds to a certain part of products. Lot size in this case is determined either by a fixed quantity or by the quantity produced over a certain period of time; 3) Declaration of the safety and quality of drug products produced in GMP countries under the conditions of ICH region, GMP of the Republic of Kazakhstan, medical devices manufactured under EN ISO 13485, GMP in ICH regional countries. ✓ Confirmation of conformity services for all industries

Like any product, nutritional supplements are subject to compulsory state registration. The state registration/re-registration of nutritional supplements in our republic is carried out by the Committee for the Protection of Public Health of the Ministry of Health of the Republic of Kazakhstan.   The necessary conditions for nutritional supplements to be registered are the presence of a label, an instruction with the necessary information for the consumer: ✓ name of products, form of presentation ✓ manufacturer’s trademark (if any) ✓information on the ingredient composition, indicating the exact amount (grams, milligrams, milliliters, percentage) of included components, nutritional value (energy value, protein, fat, carbohydrates content, vitamins and         microelements, indicating the percentage of physiological daily maintenance, amino acid content, content of biologically active substances) ✓ information on the properties of nutritional supplements, their purpose, recommendations for use ✓ name of the normative document, the requirements of which must correspond to nutritional supplements ✓ name (commercial name), location (legal address) of the manufacturer, bundler and packer (if the manufacturer is not simultaneously a bundler, a packer) ✓ nominal quantity of the packaging unit (mass or volume), number of doses and their nominal quantity (mass or volume) ✓ batch number, production date, shelf life, storage conditions ✓ indication that a nutritional supplement is not a drug product ✓ information on the state registration of nutritional supplements with the indication of the number and date ✓ information on contraindications for use in certain types of diseases The sale of nutritional supplements is not allowed when they: ✓ did not passed the state registration ✓ are expired ✓ in the absence of proper conditions for sale ✓ without a label, and also in the event that the information on the label does not correspond to information agreed upon during the state registration Confirmation of the safety of nutritional supplements is the availability of a certificate of state registration issued in accordance with the procedure approved by the authorized body in the field of sanitary and epidemiological welfare of the population.       State Registration of Dietary & Nutritional Supplements and Specialized Food Products in Kazakhstan and in Economic Union During a Coronavirus pandemic, the number of people using nutritional supplements is growing. To use nutritional supplements in daily diet or not everybody choices itself, but before you use any biological active additives check whether they have a state registration. Nutritional supplements are subject to compulsory state registration. The state registration/re-registration of nutritional supplements in our republic is carried out by the Committee for the Protection of Public Health of the Ministry of Health of the Republic of Kazakhstan. Obtaining a certificate of state registration is a verification of the safety of a nutritional supplement. The necessary environment for nutritional supplements to be registered are the presence of a label, an instruction with the necessary information for the consumer: name of products, form of presentation manufacturer’s trademark (if any) information on the ingredient composition, indicating the exact amount (grams, milligrams, milliliters, percentage) of included components, nutritional value (energy value, protein, fat, carbohydrates content, vitamins and microelements, indicating the percentage of physiological daily maintenance, amino acid content, content of biologically active substances) information on the properties of nutritional supplements, their purpose, recommendations for use name of the normative document, the requirements of which must correspond to nutritional supplements name (commercial name), location (legal address) of the manufacturer, bundler and packer (if the manufacturer is not simultaneously a bundler, a packer) nominal quantity of the packaging unit (mass or volume), number of doses and their nominal quantity (mass or volume) batch number, production date, shelf life, storage conditions indication that a nutritional supplement is not a drug product information on the state registration of nutritional supplements with the indication of the number and date information on contraindications for use in certain types of illnesses The sale of nutritional supplements is not allowed when they: didn’t pass the state registration are expired in the absence of proper stipulations for sale without a label, and also in the event that the information on the label does not correspond to information agreed upon during the state registration Confirmation of the safety of nutritional supplements is the availability of a certificate of state registration issued in accordance with the procedure approved by the authorized body in the field of sanitary and epidemiological welfare of the population. Registration of nutritional supplements is a rather longtime and difficult procedure, in which we can provide qualified assistance. Our team of professionals has extensive experience in registering nutritional supplements in Kazakhstan. By contacting us, you can be sure that all the necessary documents will be drawn up and collected by our specialists in the best possible way and in the shortest possible time. Correct preparation of documents and submission of an application contributes to the successful completion of registration. Our specialists will promptly prepare a package of necessary documents, including: statement; copies of the standards according to which the nutritional supplement is manufactured; trial report; copy of the product safety opinion issued by the health authority of the country of manufacture copy of the import permit. For a complete list of mandatory documents, leave a request for consultation on the registration of nutritional supplements in Kazakhstan and the EAEU. Cost and prices for the services of registration and re-registration of nutritional supplements / nutritional supplements in Kazakhstan and the EAEU The cost of the service of registration and re-registration of nutritional supplements will be provided after consulting a specialist in the sales department, since the cost may vary due to some factors. Order registration service Registration of Nutritional Supplements and Specialized Food Products in Kazakhstan and in Eurasian Economic Union Should you have any questions or need detailed consultation call +7 708 983 2818 2021 © Registration Registration of Nutritional Supplements in Kazakhstan and the EAEU — Re-registration and accelerated registration & Specialized Food Products in the Eurasian Economic Union — Blitzmed.com

✓ Evaluation of the quality of dossier collection for DP and MD The service implies pre-registration analysis of documents for DP and MD and preparation of an initial report on the status and quality of the registration dossier. ✓ Preparation of the registration dossier for DP and MD The team of Blitz Medica LLP will create the registration dossier for DP, MD in accordance with all rules and requirements of the authorized body. During the collection and processing of the dossier, we take into account all the needs of the Customer, not only for its successful filing and further examination, but also for the successful import and sale of this product ✓ Development of designs of packages, stickers, labels for DP and MD

✓ AND development and instructions ✓ Development of a list of changes in the registration of drug products ✓ Development of instruction for use when registering drug products

This procedure involves changing the data of a previously registered medicine or medical product. The changes made should not reduce the safety and quality of the product.   The changes are classified into: ✓ Type I changes that do not require a new registration, changes relating to amendments to the content of the registration dossier, in accordance with Annex 10 to the Rules ✓ Type II changes requiring a new registration: changes not listed in Annex 10 to the Rules relate to type II change and require a new registration Types of changes made to the registration dossier: ✓ Changing the content of the production license: changing the name of the manufacturing factory ✓ Changing the name of a medical product and / or medical equipment ✓ Change (increase/decrease in names and/or replacement) in accessories structure and/or components and/or consumables ✓ Adding/deleting indications for use; scopes; contraindications; adverse effects 1) Change of manufacturers of medical products intended for prepackaging, processing of final packaging and labeling of medical devices; accessories and (or) components and/or consumables and/or Change in the production site of the manufacturer of a medical product intended for prepackaging, processing, final packaging and labeling, accessories and/or components and/or consumables 2) Increase/decrease of the shelf life of a medical device 3) Change in storage conditions 4) Change in the quality control procedure for the finished product of a medical device 5) Change in the packaging of a medical device: the primary packaging of a medical device; secondary and/or group packaging ✓ Change of imprints, primer or other markings, stamps and inscriptions, including addition or alteration of the paint used for labeling

Registration of medicines and medical products is the main activity of our company. We will be glad to help you register any medicines and medical products in Kazakhstan and other EEU countries (Kyrgyzstan, Russia, Belarus, Uzbekistan).   In the course of work, our company undertakes the entire process, starting from the initial contact with the manufacturer (responsible person) and ending with the receipt of the registration certificate. Our main advantages: speed, professionalism, flexibility, attention to details. The major priority is the needs and wishes of the Customer. You tell us WHAT do you want to import into the territory of the country and sell it on the medical market, THE REST we take upon ourselves!