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The procedure for regulating prices of medicines State regulation of prices for medicines is carried out on the basis of the formation of maximum prices and markups for medicines. Price regulation includes the following stages and (or) activities: 1. for drugs subject to wholesale and retail sale: registration of the price or re-registration of the registered price for the trade name of the drug for wholesale and retail sale based on reference pricing formation of wholesale markups formation of maximum prices for the trade name of the drug for wholesale sale formation of retail markups formation of maximum prices for the trade name of the drug for retail sale approval of maximum prices for the trade name of the drug for wholesale and retail sale 2. for drugs intended for the provision of the guaranteed volume of medical care and (or) in the compulsory medical insurance system: registration of the price or re-registration of the registered price for the trade name of the drug within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system formation of markups within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system formation of maximum prices for the trade name of the drug within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system formation of maximum prices for the international non-proprietary name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system approval of maximum prices for the trade name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system approval of maximum prices for the international non-proprietary name of a medicine within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system The procedure for forming maximum prices and markups on medicines for wholesale and retail sales Registration of the price or re-registration of the registered price for wholesale and retail sales for the trade name of medicines Prices for medicines for wholesale and retail sales are registered or re-registered per consumer package, separately for each trade name, taking into account the dosage form, dosage, concentration, volume and packaging of the medicine. To register the price or re-register the registered price for wholesale and retail sales for the trade name of medicines in the Republic of Kazakhstan, the applicant shall submit to the state expert organization an application for registration of the price or re-registration of the registered price for wholesale and retail sales (hereinafter referred to as the application) in the period up to March 10 or September 10 of the current year in the form according to Appendix 1 to these Rules. Information about the medicine in the application shall be indicated in accordance with the registration certificate for the medicine. The maximum prices for the trade name of a medicinal product for wholesale sales are formed by adding to the registered price for wholesale and retail sales a wholesale markup differentiated based on the amount of the registered price for wholesale and retail sales per consumer package. The maximum price for the trade name of a medicinal product for a reproduced medicinal product (generic) or a biosimilar medicinal product is formed below the average value established 3 years before the expiration of the patent protection of the maximum price for the trade name of a medicinal product of the original or biological original medicinal product: for a generic — not less than 30%; for a biosimilar medicinal product — not less than 10%. The maximum prices for the trade name of a medicinal product for retail sales are formed by adding to the maximum price for the trade name of a medicinal product for wholesale sales a retail markup differentiated based on the amount of the maximum price for the trade name of a medicinal product for wholesale sales per consumer package. The maximum price for the trade name of a medicinal product for a reproduced medicinal product (generic) or a biosimilar medicinal product is formed below the average value established 3 years before the expiration of the patent protection of the maximum price for the trade name of a medicinal product of an original or biological original medicinal product: for a generic — by 30%; for a biosimilar medicinal product — by 10%. The maximum price for unregistered medicinal products when imported into the Republic of Kazakhstan on the basis of a conclusion (permit document) issued in the manner determined by the authorized body, for the prevention and (or) elimination of the consequences of emergency situations is formed and established: for wholesale sales by adding a wholesale markup to the import price (invoice) in accordance with the regressive scale of markups for consumer packaging; for retail sales — by adding to the maximum price of the trade name of the medicine for wholesale sales a retail markup in accordance with the regressive scale of markups for consumer packaging.

This procedure involves changing the data of a previously registered medicinal product or medical device. The changes made must not reduce the safety and quality of the product. Changes are classified into: Type I changes that do not require a new registration, changes concerning amendments to the content of the registration dossier, in accordance with Appendix 10 to the Rules; Type II changes requiring a new registration: changes not specified in Appendix 10 to the Rules are related to Type II changes and require a new registration. Types of changes made: Change of information about the manufacturer/production site of the medical device Change of information about the authorized representative, including information about the reorganization of the legal entity, about the change of its name, change of the last name, first name, patronymic (if any) of the address of the place of residence of the individual entrepreneur Change of the name of the medical device Change of the composition of accessories and (or) components and (or) consumables, update (installation of a new version) of the software Change of indications for use; area of ​​application; contraindications; side effects Change of manufacturers of components, accessories, consumables Increase/decrease in the shelf life of the medical device Change of storage conditions Change in the quality control procedure for the finished product of the medical device Change of the packaging of the medical device: primary packaging of the medical device; secondary and/or group packaging, transport, intermediate Change of impressions, primer or other markings, stamps and inscriptions, including the addition or change of paint used to label the medical device.

If you need to conduct a price cap analysis for medicines or medical devices, our team will be happy to help you collect the necessary documents and submit an application. To date, the Blitz Medica team has conducted more than 69 production assessments. Our specialists will advise you and help you obtain a certificate of conformity for your products. Rules for regulation, formation of maximum prices and markups for medical products The formation of maximum prices for the trade name and technical characteristics of medical devices is carried out by a state expert organization on a contractual basis. The procedure for regulating maximum prices for medical products within the framework of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance State regulation of prices for medical devices within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system is approved on the basis of the formation of maximum prices and markups on the trade name and technical characteristics of medical devices within the framework of the guaranteed volume of medical care and (or) in the compulsory medical insurance system. Regulation of maximum prices for the trade name and technical characteristics of medical devices includes the following stages and (or) activities: medical devices registration of the price of medical devices within the framework of the State Fund for Medical Assistance and (or) in the Compulsory Medical Insurance System formation of the markup of medical devices formation of maximum prices for the trade name and technical characteristics of medical devices issuance of an expert opinion medical equipment analysis of the price of medical equipment formation of markups for medical equipment formation of maximum prices for the trade name and technical characteristics of medical equipment issuance of an expert opinion How the analysis of maximum prices of medical products is carried out in Kazakhstan and the EAEU: Russia, Belarus, Kyrgyzstan and Armenia The procedure for forming maximum prices and markups on medical products within the framework of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance Formation of maximum prices and markups for medical products Prices for medical devices within the framework of the State Fund for Free Medical Care and the Compulsory Medical Insurance System are registered per unit of measurement. Maximum prices and markups for medical devices outside a living organism (in vitro) are not established. Formation of maximum prices and markups for medical equipment State expert organization conducts analysis of maximum prices for trade name and technical characteristics of medical equipment Based on the results of the analysis of maximum prices for the trade name and technical characteristics of medical equipment manufactured in the Republic of Kazakhstan, a conclusion is drawn up

We inform you that the Order of the Ministry of Health of the Republic of Kazakhstan dated November 18, 2009 No. 736 has lost its force by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. ҚР ДСМ-10 «On approval of the rules for conducting examination of medicines and medical devices». In accordance with the updated legislation of the Republic of Kazakhstan, accelerated registration of medical devices is carried out only by decision of the authorized body in the field of health. In cases where it is necessary to use MI to prevent emergencies, the occurrence and elimination of the consequences of an epidemic, a pandemic of infectious diseases — an accelerated examination is carried out within a period not exceeding 30 working days for all manufacturers, regardless of the country of manufacture. Accelerated examination of medicinal products is carried out by decision of the authorized body in the field of health care (the Committee for Medical and Pharmaceutical Control or the Regional Health Department) and is carried out in the following cases: the purpose of the medicinal product for the prevention, treatment, diagnosis of rare diseases; prevention of emergencies, occurrence and elimination of the consequences of an epidemic, pandemic of infectious diseases. Accelerated examination of a medicinal product is carried out within a period not exceeding 70 calendar days, including: initial examination — no more than twenty calendar days specialized examination — no more than forty calendar days formation of a conclusion on the safety, effectiveness and quality of the medicinal product, draft final documents of the examination of medicinal products — no more than 10 calendar days. Laboratory tests are not carried out during accelerated examination of medicines. Registration deadlines are indicated from the date of filing the registration application. Accelerated registration and re-registration of medical equipment and drugs in the Republic of Kazakhstan When conducting an accelerated procedure, the requirements for safety, quality and effectiveness of medicines are not reduced. To conduct state registration of medicines or medical devices under the accelerated procedure, it is necessary to obtain confirmation letters from the Committee for Medical and Pharmaceutical Control or the Health Department of the region. It is also important to take into account that the specified time frame does not include the time for replenishing the incompleteness of the registration dossier. Therefore, in order to pass the examination as quickly as possible, it is necessary to initially correctly collect the complete registration dossier. Order a service for accelerated registration of medicines, drugs, equipment and products in the Republic of Kazakhstan If you need accelerated registration of a medical device or medicine, Blitz Medica specialists will help you collect documents and submit an application as soon as possible. Our team has successful experience in accelerated registration of medical devices. In May 2020, we registered the hardware and software screening diagnostic complex «APSDC» of Kazakhstani production, under the accelerated procedure. The complex has several modules, including a thermal imaging module for measuring human body temperature, which in turn is included in the list of products subject to accelerated examination. APSDC was successfully registered. Also, under the accelerated procedure, our team registered personal protective equipment and other medical devices. Our team has successful experience in registering medicines and medical devices. We have received more than 380 registration certificates. Thanks to our experience, we will collect the registration dossier in the shortest possible time and help to avoid errors when submitting an application, which in turn also affects the timing of registration of medicines and medical devices.

This service point of Blitz Medica LLP includes several procedures carried out in the field of metrology: Inclusion in the Register of the State Measurement System of the Republic of Kazakhstan The procedure for recognizing the certificate of measuring instruments of the EAEU countries Verification of equipment included in the register of measuring instruments Metrology: Obtaining a certificate of measuring instruments in Kazakhstan and approval of the type of measuring instruments in the Republic of Kazakhstan A medical device is a device for diagnosing, preventing or treating diseases. Medical devices may include instruments, devices, consumables, etc. Some medical devices are measuring instruments and require regular verification by government agencies. In addition to State Registration, such medical devices must obtain a certificate of approval of the type of measuring instrument in the Republic of Kazakhstan and the EAEU. Obtaining a certificate of measuring instruments and inclusion in the Register of the Republic of Kazakhstan and the Eurasian Economic Union: prices, cost and description of services According to the legislation of the Republic of Kazakhstan «On ensuring the uniformity of measurements» Measuring instruments manufactured in series are subject to type approval Measuring instruments manufactured by domestic pharmaceutical manufacturers or imported in batches are subject to batch type approval. The decision on approval of the type of measuring instruments is made by RSE «KazInMetr», based on positive test results and is certified by a certificate of approval of the type of measuring instrument. Tests for the purpose of approving the type of a batch and for compliance with the approved type of measuring instruments are carried out by the State Scientific Medical Center, including using the material and technical base of accredited testing, verification / calibration laboratories of the Republic of Kazakhstan and the EAEU. Cost and prices for services for obtaining certificates of measuring instruments in the Republic of Kazakhstan and the EAEU If you are a manufacturer or distributor of medical devices and need type approval of a measuring instrument or other services in the field of metrology, the Blitz Medica team is ready to help you obtain a conclusion on the approval of measuring instruments.

Registration and certification of perfumery and cosmetic products in the Republic of Kazakhstan and the EAEU countries Perfumery and cosmetic products (hereinafter referred to as perfumery and cosmetic products) must undergo state registration before they are put on sale. State registration of perfumery and cosmetic products is carried out in accordance with the Technical Regulations of the Customs Union «On the safety of perfumery and cosmetic products» dated September 23, No. 799. According to the regulations, perfumery and cosmetic products are allowed to be sold if they comply with the technical regulations of the CU 009/2011, as well as other technical regulations of the CU, the requirements of which affect them. There are certain criteria for the safety of products, including requirements for composition, labeling, packaging, toxicological and clinical laboratory indicators and the production of a specific product. The final result of state registration is a certificate of state registration, the result of declaration is a declaration of conformity of perfumery and cosmetic products with the Technical Regulations of the CU. SGR and declaration of conformity are provided for one or several names of perfumery and cosmetic products of the same type. The state registration certificate is issued by a special division of the Ministry of Health. Also, perfumery and cosmetic products can be registered in any of the countries of the Customs Union and the SGR will be valid in all participating countries. Perfumery and cosmetic products are registered once upon initial import.Upon receipt of the state registration certificate for perfumery and cosmetic products, the data is reflected in the Unified Register of State Registration Certificates. The package of documents for submission to the regulatory authority for state registration of perfumery and cosmetic products includes such documents as copies of technical documents, a certificate of product quality provided by the manufacturer, ISO, GMP certificates, annotations, and expert reports. The procedure for registration and declaration of perfumery and cosmetic products in Kazakhstan is a complex procedure and requires good knowledge of regulatory acts and the Technical Regulations of the Customs Union, in connection with which, we recommend contacting professionals who know all the details and have experience in registering perfumery and cosmetic products. By contacting professionals, you will save yourself unnecessary worries and time and be confident in the successful receipt of permits. Blitz Medica employees can take on all the difficulties of registration and declaration, all you have to do is provide the initial list of documents and wait for the receipt of permits. We will help with declaration and registration of cosmetics: Children’s Decorative Intimate For tattooing (ink for tattooing) Professional cosmetics (hairdressing, manicure and pedicure) Skin care (creams, lotions, peelings, scrubs, gels) Perfumery products (perfumes, colognes, eau de parfum) Artificial tanning products (self-tanner) Oral hygiene products (rinses) Cost and prices for registration and certification services for cosmetics, perfumes, toothpaste and perfumes in the Republic of Kazakhstan and the EAEU The main activity of Blitz Medica is obtaining medical permits. We have been working in the RK market since 2014 and have implemented more than three hundred projects in six years. Most of our partners cooperate with us on a permanent basis, thanks to our individual approach to each client and constant desire to improve the quality of services.

This service is provided in cases where the Client needs to make a one-time import of an unregistered medical product to the Republic of Kazakhstan. In the course of solving this problem, Blitz Medica LLP selects the optimal import option in accordance with the Code of the Republic of Kazakhstan «ON PEOPLE’S HEALTH AND THE HEALTHCARE SYSTEM» and Order No. ҚР ДСМ-237/2020. The service is completed by issuing an import permit document from the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan.     Kazakhstan prohibits the import of medical products, medicines and medical equipment that have not received a registration certificate Before importing a batch of medical products, medicines and medical equipment, it is necessary to carry out state registration of the medicines/medical equipment. But what to do in emergency cases, when certain circumstances do not allow obtaining a registration certificate or the time frame is very limited? For emergency and exceptional circumstances, it is necessary to obtain a permit for a one-time import of medical products or a permit for the import of a medicine. According to the Code of the Republic of Kazakhstan «On the Health of the People and the Healthcare System», the import of medical products, medicines and medical equipment that have not been registered is permitted in cases of import for the purpose of: Stages and terms of registration of medical devices according to the national procedure clinical trials examination of medicines for the purpose of state registration of medical products, medicines and medical equipment providing medical assistance to a specific patient or group of patients with a rare or particularly severe pathology; in the form of an exhibition display (without the right of subsequent use or sale) prevention/elimination of consequences of emergency situations integration of innovative technologies in the field of Healthcare procurement by a single distributor of medical products, medicines and medical equipment supplied by international organizations established by the UN General Assembly use as a component included in the composition or device of a medical device prevention and treatment of the effects of exposure to radioactive, biological and chemical substances (vaccines, antidotes) It is worth noting that medical products, medicines and medical equipment imported into the country for the above purposes are not allowed for sale and subsequent use without state registration. How can I obtain a one-time import permit? The term of service provision by the state body is 3 working days and the permit document is issued free of charge. In case of emergency, for example, the current coronavirus pandemic, there is a confirmed list of medical products that fall under this category: thermometers, personal protective equipment, medicines and other medical products. When there is a need for a one-time import of a medicine or device to a specific patient, if Kazakhstan cannot provide treatment and only the device/drug can save the patient, then a letter of request from the medical institution is required, which indicates the full name of the patient, information about his diagnosis. If the permit for a one-time import is issued for medical equipment or a device for the purpose of exhibiting at exhibitions, then it is necessary to provide a letter of confirmation from the exhibition organizer about participation and an agreement/invoice. And also after the end of the exhibition, the equipment must be returned back to the country of manufacture. When registering a one-time import of a medicine or medical product not registered in Kazakhstan, the application must include quality certificates, a certificate of analysis. An important point is the availability of a notarized translation of documents into the state or Russian language.

Like any product, dietary supplements are subject to mandatory state registration. State registration/re-registration of dietary 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 dietary supplements subject to registration are the presence of a label and instructions with the necessary information for the consumer: name of product, release form Manufacturer’s trademark (if any) information on the ingredient composition indicating the exact quantity (grams, milligrams, milliliters, percentage ratio) of the components included in them, nutritional value (energy value, content of proteins, fats, carbohydrates, vitamins and microelements indicating the percentage of the physiological daily requirement, amino acid composition, content of biologically active substances) information about the properties of biologically active food supplements, their purpose, recommendations for use name of the regulatory document, the requirements of which must be met by biologically active food supplements name (company name), location (legal address) of the manufacturer, packer and packager (if the manufacturer is not also the packer or packager) nominal quantity of the packaging unit (weight or volume), number of doses and their nominal quantity (weight or volume) batch number, production date, expiration date, storage conditions indication that a dietary supplement is not a medicine information on state registration of a biologically active food supplement with the number and date information on contraindications for use in certain types of diseases Certification of dietary supplements in the Republic of Kazakhstan and the EAEU (Eurasian Economic Union) Registration of dietary supplements is a rather slow and complicated process, in which we can provide qualified assistance. Our team of professionals has extensive experience in registering dietary supplements in the Customs Union. 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 registration, preparation of documents and submission of an application contributes to the successful completion of registration. During the pandemic, the number of people using dietary supplements (hereinafter referred to as dietary supplements) is growing. Although a dietary supplement is not a drug, in the Republic of Kazakhstan, dietary supplements must undergo mandatory state registration. Obtaining a state registration certificate is a verification of the safety of a dietary supplement. Biologically active food supplements undergo state registration/re-registration with the Committee for Quality Control and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan. When passing the required tests and checking the documentation of compliance with the safety standards of dietary supplements, they are divided into three groups: Products considered special (dietary) Functional foods Dietary supplements

Blitz Medica LLP undertakes the collection, design and preparation of advertising materials, and also supports this process in the RSE on the Right of Economic Management «National Center for Expertise of Medicines, Medical Devices and Medical Equipment» until a positive conclusion is issued. A mandatory condition for issuing a permit for advertising of medicines, medical devices and medical equipment is a preliminary examination of the advertising material in a state expert organization. A permit for advertising is issued for the validity period of the registration certificate of medicines, medical devices and medical equipment in the form according to Appendix 2 to the Standard of the state service «Issuance of a permit for advertising of medicines, medical devices and medical equipment», approved by the Decree of the Government of the Republic of Kazakhstan dated October 8, 2012 No. 1262. The advertised properties and characteristics of medicines, medical devices and medical equipment, regardless of the type of advertising, must comply with the instructions for medical use approved by the authorized body during state registration, the operational document for medical equipment. Medicines, medical devices and medical equipment distributed as advertising samples must be registered in the Republic of Kazakhstan and accompanied by instructions for medical use and an operating document (for medical equipment). On the rules for advertising medicines and medical products in Kazakhstan: approval of advertising materials for advertising medicines When advertising medicines and medical devices, not only the creativity of the marketing and PR department is important, the main factor is that advertising materials must undergo mandatory expert assessment for compliance with the legislation of the Republic of Kazakhstan in the field of healthcare, before being launched in the media. The rules for advertising medicines and medical devices are regulated by the Order of the Ministry of Health of the Republic of Kazakhstan KRDSM 288/2020 dated 20.12.2020. Medicines that are sold without a prescription are allowed for advertising in the media and journalistic materials. Medicines sold by prescription are allowed to be advertised in special printed publications for health workers and employees of the pharmaceutical sector. Obtaining permission to advertise medical products and equipment in Kazakhstan Advertising of medicine and medical devices must meet the following criteria: be published in Kazakh and Russian languages be easy to read it is obvious that the subject of promotion is a drug or medical device be truthful and recognizable not compared with competitive drugs or medicines do not misinform recipients by abusing their trust and other criteria An advertising permit is issued for the validity period of the registration certificate of medicines, medical devices and medical equipment in the form according to Appendix 2 to the State Service Standard «Issuance of a permit for advertising medicines, medical devices and medical equipment», approved by the Decree of the Government of the Republic of Kazakhstan dated October 8, 2012 No. 1262. The advertised properties and characteristics of medicines, medical devices and medical equipment, regardless of the type of advertising, must comply with the instructions for medical use approved by the authorized body during state registration, the operating document for medical equipment. Medicines, medical devices and medical equipment distributed as advertising samples must be registered in the Republic of Kazakhstan and accompanied by instructions for medical use, an operating document (for medical equipment).

During the work, our company takes on the entire process, starting from the initial contact with the manufacturer (responsible person) and ending with obtaining a registration certificate. Our main advantages: speed, professionalism, flexibility, attention to detail. The main priority is the needs and wishes of the Client. You tell us what you want to import into the country and sell on the medical market, we take care of the rest! Cost and prices for services for registration of medicines in the Republic of Kazakhstan, the Russian Federation and the Republic of Belarus – the EAEU countries If you need to register medicines according to the EAEU rules, we recommend that you contact professionals, as you may encounter a number of problems. Our company’s specialists have experience in successfully registering medicines in Kazakhstan and in the EAEU countries. Our team has already registered more than 310 medicines/medical products in six countries. We are ready to provide a free consultation on registering medicines in Kazakhstan and the EAEU countries, including registering medicines according to the EAEU Rules. The main problems of independent registration of medicines in the EAEU include: The opportunity to encounter a large amount of information The procedure for registering medicines in the EAEU may take several years or more Lack of communication knowledge in the country Possibility of encountering difficulties during paperwork The advantages of examination and registration of medicines according to the rules and within the framework of the EAEU with the help of Blitz Medica specialists: The organization will take care of all issues related to the preparation of documentation. Saving time. At the same time, Blitz Medica specialists will try to register the medicine in the EAEU and the Republic of Kazakhstan in the shortest possible time. Qualified specialists understand different areas of activity. They are able to cope with a task of any complexity Professionals select an individual approach to each project The company guarantees confidentiality Our company offers the service of registration of medicines within the EAEU at an affordable price. At the same time, we guarantee constant support and feedback, as well as meet all deadlines and control the process of work. Our company has a positive reputation, confirmed by numerous reviews from our partners, you can read the reviews here. According to the rules in force in the Republic of Kazakhstan, the following goods are subject to mandatory recording and inspection: hybrid medicine reproduced medicine well-studied medicine original medicine combination medicine, etc. The sale of unregistered medicines is prohibited on the territory of the Republic of Kazakhstan When a medicine is registered, the following information is included in the state registry: Registration number Order number Registration type Registration deadline The date on which the expiration date will occur Storage period and conditions Name of the medicine Brand and country where the product is manufactured Type of medication Composition and dosage Manufacturer and marketing authorization holder Thanks to this information, in the section «State Register — Search for Medicines» you can find information about whether a particular medicine is registered. This list is updated daily.The information contained in the state register allows health workers, pharmacists and consumers to navigate the medicines. Thus, some medicines will not be dispensed without a prescription. Registration of medicines is necessary in order to provide the population of Kazakhstan with high-quality, effective and safe medicines, which in turn will lead to an improvement in the general health of the population. During the registration procedure of a medicine, the product is checked for the content of various impurities and additives that can harm human health. That is why preclinical and clinical trials are carried out during the registration of medicines in Kazakhstan. There is no need to register medicines in the EAEU if the drug was manufactured according to pharmacy prescriptions. Registration of medicines in the Republic of Kazakhstan is carried out in several stages: In the reference state: In the state of recognition: