of July 18, 2025 No. 67, on July 22, 2025 No. 380/Tax Code
About carrying out pilot project on state registration of medicines and medical products by the principle of "single window"
According to article 22 of the Law of the Republic of Kazakhstan "About the state services", and also for the purpose of process optimization of rendering the state service of PRIKAZYVAYEM:
1. In all areas, the cities of republican value, the capital of the Republic of Kazakhstan to start pilot project on rendering the state service "Issue of registration of medicines and medical products by the principle of "single window".
2. Approve Rules of registration of medicines and medical products by the principle of "single window" according to appendix to this order.
3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:
1) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
2) within five calendar days from the date of approval of this joint order the direction in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan.
4. To impose control of execution of this joint order on the supervising vice-Minister of Health of the Republic of Kazakhstan and the supervising vice-minister of digital development, innovations and the aerospace industry of the Republic of Kazakhstan.
5. This joint order becomes effective from the date of its first official publication and extends to the legal relationship which arose since July 1, 2025 and is effective till December 31, 2025.
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Minister of digital development, innovations and aerospace industry of the Republic of Kazakhstan
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__________ Zh. Madiyev |
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Minister of Health of the Republic of Kazakhstan
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__________ A. Alnazarova |
Appendix
to the joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of digital development, innovations and the aerospace industry of the Republic of Kazakhstan of July 18, 2025 No. 67, on July 22, 2025 No. 380/Tax Code
1. These rules of registration of medicines and medical products by the principle of "single window" (further – Rules) are developed according to article 22 of the Law of the Republic of Kazakhstan "About the state services" (further – the Law), article 19 of the Law of the Republic of Kazakhstan "About informatization" and determine procedure for rendering by the principle of "single window" of the state services "Registration of the Price of Medicines and Medical Products", "State Registration, Re-registration of Medicine or Medical Product, Modification of the Registration File of Medicine or Medical Product", "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products", and also conducting professional examination and are applied to inclusion in the Kazakhstan national medicinal form on voluntary and alternative basis.
2. Examination of medicines or medical products, registration of the price, modification of the price of the producer is carried out by the state expert organization in the sphere of drug circulation and medical products (further – the state expert organization).
3. State registration, re-registration, modification of the registration file of medicines or medical products is performed by state body in the sphere of drug circulation and medical products.
4. Professional examination is performed by the subordinated organization of authorized body which competence questions of conducting the examination providing assessment of the data on clinical safety and efficiency of medicine confirmed in clinical trials and also in meta-analyses and (or) in systematic reviews enter (further – the Center).
5. Examination, including implementation of the translation of documents into Kazakh, registration of the price, modification of the price of the producer, and also professional examination of medicines or medical products is carried out based on the signed agreement according to the civil legislation of the Republic of Kazakhstan before rendering composite state service.
6. Payment of cost of registration of the price of the producer and modification of the price of the producer, and also professional examination is performed according to the price list of the prices established by the state expert organization and the Center.
7. Payment of cost of examination of medicine or medical product is performed according to the price list established by authorized body in coordination with antimonopoly authority according to the order of the acting minister of health care of the Republic of Kazakhstan of January 20, 2021 No. KR DSM-7 "About price approval on the goods (works, services) made and (or) realized by the subject of the state monopoly" (it is registered in the Register of state registration of regulatory legal acts at No. 22096).
8. Payment of cost of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product is performed according to the Code of the Republic of Kazakhstan "About taxes and other obligatory payments in the budget (Tax code)".
9. Registration of the price or modification of the registered price of the producer of medicine and medical products is performed in national currency of the Republic of Kazakhstan.
10. The medicines or medical products made in the Republic of Kazakhstan, and also imported on its territory are subject to examination, and also registration of the price and modification of the price of the producer.
11. Before filing of application for examination of medicines or medical products, state registration, re-registration of medicines or medical products, modification of the registration file of medicine or medical product and registration, modification of the price of the producer the applicant on own initiative on contractual basis receives in the state expert organization the decision following the results of examination of belonging of products to medical products and need of its state registration in the Republic of Kazakhstan, and also information and consulting services on the questions connected with conducting examination of medicine or medical product.
For receipt of the conclusion on products belonging to medical products the applicant by means of the portal of the state expert organization provides the following materials and documents with the authentic translation into the Kazakh and Russian languages:
1) product name;
2) name of the producer, country;
3) instruction for application either operational document, or user's guide;
4) the photographic image displaying appearance of products at least 18 x 24 centimeter in size;
5) information on registration in the country of the producer issued by the state authorized body of the country of the producer;
6) the technical description, scope, purpose of products (information from the producer).
The state expert organization carries out expertize of belonging of products to medical products within 15 (fifteen) working days from registration date of the statement and provision by the applicant of documents in the state expert organization.
In case of provision by the applicant of doubtful data, incomplete document package and availability of notes to the submitted documents and (or) materials, in information system of the state expert organization in private office of the applicant the notification (in any form) about need of elimination of the revealed notes in time, not exceeding 5 (five) working days, from the date of drawing of notes by the state expert organization is placed.
For the period of elimination of notes, terms of consideration of the application stop.
In case of not elimination by the applicant of the notes specified in this Item of the specified Rules, the state expert organization sends to the applicant the solution on the termination of examination of belonging of products to medical products and need of its state registration in the Republic of Kazakhstan in any form.
Examination of belonging of products to medical products is performed by carrying out the analysis of the provided materials and documents taking into account scope and purpose of the declared products.
When carrying out the analysis data from the State register of medicines and medical products are considered.
By results of examination of belonging of products to medical products of the applicant by means of information system of the state expert organization the conclusion about products belonging to medical products in any form with effective period from the date of its issue goes no more than 12 (twelve) months to "private office" of the applicant.
12. In these rules the following terms and determinations are used:
1) medical products for in vitro of diagnostics of open type – medical products for diagnostics of in vitro which operation according to their functional purpose is possible when using reagents (reactants) of wide range of producers;
2) the software is medical product on condition of compliance to its all following criteria:
represents the computer program or its modules regardless of the used platform equipment room, and also methods of placement of the software and provision of access to it;
is not component of other medical product;
it is intended by the producer for delivery of health care;
the result of action of the software consists in interpretation in the automatic mode, including with use of technologies of artificial intelligence, or in the parameters set by the health worker influencing adoption of the clinical decisions, data set received from the medical products allowed to the address in accordance with the established procedure or entered by health workers for the purpose of delivery of health care;
3) biosimilar medicine (bioanalogue, biosimilar medicine, biosimilyar) – biological medicine which contains the version of active ingredient, the registered biological original medicine or reference medicine and on which similarity (similarity) on the basis of comparative researches on indicators of quality, biological activity, safety and efficiency is shown;
4) the bioveyver procedure – the procedure according to which determination of equivalence of the reproduced medicine (generic) is carried out based on biopharmaceutical classification system and results of comparative researches out of organism (in-vitro) with testing use "Dissolution" and is applied to firm dosage forms of immediate release (1 and 3 class on biopharmaceutical classification system);
5) bioavailability – the speed and degree with which active agent is soaked up from dosage form and becomes available in the scene of action;
6) biological equivalence (bioequivalence) – lack of significant distinctions on the speed and degree with which active ingredient or active part of molecule of active ingredient of pharmaceutical equivalents or pharmaceutical alternatives become available in the place of the action in case of introduction in identical molar dose in similar conditions in research with proper design;
7) biological medicine – medicine which active ingredient is made or emitted from biological source and the description of properties and which quality control requires combination of biological and physical and chemical methods of the analysis to assessment of production process and methods of its control;
8) biotechnological medicine – the medicine made by means of bioengineering procedures and application of methods with use of technology of recombinant deoxyribonucleic acid, controlled expression of the genes coding development of biologically active proteins, gibridomny technologies, monoclonal antibodies or other bioengineering procedures;
9) biopharmaceutical classification system (further – BSK) – scientific classification system of active agents on the basis of their solubility in circles with certain indicator of acidity (alkalinity) (pH) and extent of penetration through intestines wall;
10) original medicine – medicine with new active ingredient which was registered and placed by the first in the world pharmaceutical market, based on the file containing results of the complete preclinical (not clinical) and clinical trials confirming its safety, quality and efficiency;
11) price analysis of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor - pricing analysis system on the trade name and technical characteristic of medical product for diagnostics out of live organism (in vitro) made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor based on determination of the price of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor by accessories from the producer, expenses connected with delivery and markup in case of realization;
12) the Unit of measure of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor - one model of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor;
13) model of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor - independent unit of medical product for diagnostics out of live organism (in vitro), made in the territory of the Republic of Kazakhstan within the long-term agreements of delivery signed with the Single distributor, identified by the producer of medical product certain alphabetic, digital or alphanumeric reference;
14) hybrid medicine – the medicine which is not falling under determination of the reproduced medicine in case of impossibility of confirmation of its bioequivalence by means of bioavailability researches and also if in this medicine there were changes of active ingredient (substances), indications to application, dosages, dosage form or way of introduction in comparison with original medicine;
15) homeopathic medicine – the medicine made on homeopathic technology with use of homeopathic raw materials according to requirements of pharmacopeias of the Republic of Kazakhstan and (or) the Eurasian Economic Union or in case of their absence according to requirements of homeopathic pharmacopeias;
16) medicine – the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;
17) the conclusion about safety, quality and efficiency of medicine – the document containing results of examination declared on state registration, re-registration or modification of the registration file of medicine;
18) irrational combination of composition of medicines – the composition of medicine which is not corresponding to expected pharmacological properties and action;
19) state body in the sphere of drug circulation and medical products (further – state body) – the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products;
20) the State register of medicines and medical products - the electronic information resource containing data about the medicines registered and allowed for medical application in the Republic of Kazakhstan and medical products;
21) the state expert organization in the sphere of drug circulation and medical products – the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products;
22) modification of the registration file of medicine or medical product – the procedure performed based on examination of the changes made to the registration file during effective period of the registration certificate;
23) the regulating document on quality of medicine – the document establishing requirements to quality control of medicine during the post-registration period based on the carried-out expertize of medicine in case of its registration and containing the specification, the description of analytical techniques and testing of medicine or the reference to such testing, and also the corresponding eligibility criterions for quality indicators;
24) producer of medicines – the organization which is performing activities for production of medicines and having the license for production of medicines;
25) reference pricing on medicine - the analysis system of the prices of the trade name of medicine based on the prices of the same producer of medicine provided by the applicant with the same active agent taking into account dosage form, concentration, amount and dosage in the reference countries and these websites of the international organizations, including in the LS producer country in case of its realization, and also the actual price of import to the Republic of Kazakhstan;
26) medicine unit of measure (purchase unit) – unit of the dosed (divided) dosage form or the amount (weight) of not dosed (undivided) dosage form limited to primary package for medicine;
27) medicinal vegetable medicine – the medicine containing in quality of active components exclusively medicinal vegetable raw materials and (or) medicines on its basis;
28) medicinal vegetable raw materials – the fresh or dried-up plants, seaweed, mushrooms or lichens or their parts, integral or crushed, used for production of medicines;
29) general characteristic of medicine (further - OHLP) - the document approved by authorized body in case of state registration of medicine, containing information for health workers on safe and effective use of medicine;
30) the instruction on medical application of medicine (leaf insert) (further - IMP) – the document containing information for the consumer and accompanying medicine in packaging;
31) standard samples of medicinal substances and their impurity – the comparison substances used when conducting examination of examinees of medicines;
32) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);
33) dosage – amount (content) of active ingredient in unit of dosage form, and also in unit of mass or medicine amount, significant for the correct identification and use of medicine;
34) medical products for in vitro of diagnostics of the closed type – medical products for diagnostics of in vitro which operation according to their appointment is possible only when using special reagents (reactants) provided by the producer for this medical product and its modifications included in its picking;
35) consumable materials to the medical product in vitro of diagnostics of the closed type – the consumable materials providing its full functioning according to the set purpose and included in its picking for use with this medical product;
36) medicine with well studied medical application – medicine which active agent is well studied during medical application at the same time its efficiency and acceptable degree of safety confirmed with detailed bibliographic references to the published data on post-registration and (or) epidemiological researches are acknowledged and there passed at least 10 years from the date of the first systematic and documentary use of active ingredient (active ingredients) of this medicine;
37) immunological medicine (immunobiological medicine) – the medicine intended for forming of active or passive immunity or diagnostics of availability of immunity, or diagnostics (development) of the specific acquired change of the immunological answer to allergiziruyushchy substances;
38) medical products for diagnostics of in vitro (in vitro) – any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or in combination among themselves and also together with the accessories necessary for application of the specified products to destination, including the special software, and information of rather physiological or pathological condition, congenital pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer of medical product for application in case of the researches invitro of samples of biological materials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;
39) the Incoterms 2020 - the international trade term of standard agreement provisions of the international purchase and sale which are developed and determined by International Chamber of Commerce;
40) uslugopoluchatel – subjects of receipt of service physical persons and legal entities, except for the central state bodies, foreign institutions of the Republic of Kazakhstan, local executive bodies of areas, the cities of republican value, the capital, areas, the cities of regional value, akims of areas in the city, the cities of district value, settlements, villages, rural districts;
41) the service provider – the central state bodies, foreign institutions of the Republic of Kazakhstan, local executive bodies of areas, cities of republican value, the capital, areas, cities of regional value, akims of areas in the city, the cities of district value, settlements, villages, rural districts, and also the physical persons and legal entities rendering the state services according to the legislation of the Republic of Kazakhstan;
42) the Kazakhstan national medicinal form – the list of medicines with the proved clinical safety and efficiency, and also orphan (rare) medicines which is obligatory basis for development of medicinal forms of the medical organizations and forming of lists of purchase of medicines within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;
43) the risk management plan – the detailed description of risk management system;
44) the periodic updated report on safety – the report of the holder of the registration certificate of medicine for certain period of time during the post-registration period provided for ratio assessment "advantage – risk" medicine;
45) the reproduced medicine (generic) – medicine which has the same quantitative and high-quality composition of active ingredients and the same dosage form, as original medicine and which bioequivalence to original medicine is confirmed by the corresponding researches of bioavailability. Various salts, air, isomers, mixes of isomers, complexes or derivatives of active ingredient are recognized the same active ingredient if their safety and efficiency significantly do not differ. Various dosage forms for intake with immediate release of substances are recognized within the bioavailability researches the same dosage form;
46) the commercial offer - the document containing information about medical product, accessories and consumable materials, quantity, the name, model, the producer with indication of cost by picking, and also information on delivery conditions, carrying out guarantee and post-guarantee field service (specifying of terms) and possibility of training of specialists of the organization of health care;
47) medical products – products of medical appointment and medical equipment;
48) the name of medical product – the verbal designation of medical product determining it functional purpose, model, version, modification, type;
49) the accessory of medical product – the part of medical product which is not independent medical product including blocks, parts, the product elements, materials, spare parts provided by the producer for use according to functional purpose, operational characteristics, management of the producer on field service;
50) set (set) of medical products - the set of the medical products united by general functional purpose and scope, having general marking with indication of the list of the medical products which are part of set (set) according to documentation of the producer;
51) belonging to medical products – the product which is not medical product, intended by the producer for combined use with one or several medical products for use according to their appointment;
52) safety of medical product – lack of unacceptable risk when using the medical product connected with damnification of life, to health of the person, and also the environment;
53) the conclusion about safety, quality and efficiency of medical product – the document containing results of examination of the medical products declared for examination;
54) component of medical product – the main unit (part) of medical product, the accessory, accessory, consumable material, reagent to medical product;
55) modification of medical product – the kind of medical product having general with the main medical product the constructive, technological signs developed based on the main product for the purpose of its enhancement, expansion of functional purpose, application or specialization of application in the medical purposes;
56) the main unit of medical equipment (devices, devices, the equipment) – the element (node) of medical equipment (in the presence) provided by the producer, which is integral part of medical equipment, providing its functioning according to appointment and the operation manual and to field service of the producer;
57) unit of measure of product of medical appointment - one unit of product of medical appointment taking into account packing, completeness or primary package;
58) the producer of medical product – the subject in the sphere of drug circulation and medical products, responsible for development and production of medical product, making it available for use on its own behalf irrespective of, it is developed and made by this person or from his name other person (persons), and bearing responsibility for its safety, quality and efficiency;
59) quality of medical product – degree of compliance of set of properties and characteristics of medical product to the purposes of its intended use;
60) the document on quality of medical product (further – the document on quality) – documents (international, regional), the national standards, standards of the organization establishing complex of quality requirements, safety, to techniques of testing, and also transportation and storage of medical products;
61) efficiency of medical product – set of the properties and characteristics of medical product providing goal achievement of purpose, established by the producer of medical product and confirmed with practice of its use;
62) consumable material to medical products – the products and materials spent when using medical products, providing carrying out manipulations according to functional purpose of medical product, operational characteristics, management on field service of the producer;
63) the countries of the region of the International conference on harmonization of technical requirements to registration of medicines for medical application (ICH) (Aysieych) – the states which regulatory bodies are part of founders and permanent members of ICH (the country of the European Union, Great Britain, the United States of America, Japan, Switzerland, Canada) (further – the countries of the region of ICH (Aysieych));
64) products of medical appointment – the materials, products, solutions, reagents, sets, sets used for delivery of health care according to functional purpose and the instruction of the producer;
65) reference pricing on products of medical appointment - the analysis system of the prices of the trade name and technical characteristic of product of medical appointment based on the prices of the producer provided by the applicant in accordance with the terms of the DDP INCOTERMS 2020, the same producer of the same medical product taking into account completeness, type and tiporazmerny row, and also the actual price of deliveries to the Republic of Kazakhstan;
66) medical equipment – the devices, devices, the equipment, complexes, systems applied separately or in combination among themselves to delivery of health care according to the functional purpose and operational characteristics established by the producer;
67) the state service - one of the forms of realization of the separate state functions or their set performed according to the address or without address of uslugopoluchatel and directed to realization of their rights, freedoms and legitimate interests, provision of the corresponding material or non-material benefits by it;
68) Advisory council of the state expert organization (further – Advisory council) – the collegiate organ created in the state expert organization for consideration of matters of argument in results of examination, the bases (reasons) of issue of the negative conclusions about safety, quality and efficiency of medicines and medical products and to acceptance of the final decision, except for refusal on violation of terms of composite state service by the applicant;
69) model – the independent unit of medical product identified by the producer of medical product certain alphabetic, digital or alphanumeric reference;
70) medicines of the advanced therapy (further – LPPT) - the medicines of medical application which are medicines of gene therapy, therapy by somatic cages, tkaneinzhenerny medicines or the combined medicines for the advanced therapy;
71) orphan (rare) medicine – the medicine intended for diagnostics, etiopatogenetichesky or pathogenetic treatment of orphan (rare) diseases which frequency does not exceed officially certain level in the Republic of Kazakhstan;
72) the production site – territorially isolated complex of the producer of medicines, medical products intended for accomplishment of all production process of medicines, medical products or its certain stages;
73) the authorized representative of producer – the legal entity or physical person registered as the individual entrepreneur, which is resident of the Republic of Kazakhstan, authorized by the power of attorney of the producer of medical product to represent its interests concerning the address of medical product in the territory of the Republic of Kazakhstan according to the current legislation of the Republic of Kazakhstan in the field of health care;
74) the applicant – the physical person or legal entity which is the producer (manufacturer) or their representative, developer, the owner or the holder of the registration certificate or their authorized representative authorized to submit the application, documents and materials and to perform the operations provided by the power of attorney of the principal on conducting examination of medicine and medical product for registration, re-registrations, modification of the registration file competent to submit applications, documents and materials for registration of the price or re-registration of the registered price of medicine or medical product, professional examination;
75) radio pharmaceutical medicine – the medicine containing in condition, ready for application, one or several radionuclides (radioactive isotopes) as active ingredient or as a part of active ingredient;
76) the reference countries – the countries of the European and Central Asian region macroeconomically comparable to the Republic of Kazakhstan relating to group of the countries high, above average or below average the income, according to classification of the World Bank by the estimative level of gross national income per capita, from category credited by the International Bank for Reconstruction and Development (Azerbaijan, Belarus, Bulgaria, Hungary, Kyrgyzstan, Poland, Russia, Slovenia, Turkey, Uzbekistan);
77) reference medicine – medicine which is used as medicine of comparison and is standard by which are determined properties of medicine (are normalized);
78) proper production practice – the component of system of quality assurance guaranteeing production and quality control of medicines according to standards according to their purpose and requirements of the registration file;
79) tiporazmerny row – number of the products made of uniform raw materials with general physical and chemical properties on general engineering procedure, the having single functional purpose and application differing only in the sizes and (or) amount and (or) color according to documentation of the producer;
80) the registration file – the set of documents and materials of the established content represented to the statement for examination of medicine or medical product;
81) the holder of the registration certificate – the legal entity who is the resident or the nonresident of the Republic of Kazakhstan addressed to whom the registration certificate on medicine is issued;
82) the registered price for wholesale and retail sale, and also within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance – the estimated basic price for the trade name of medicines for ceiling forming of price for the trade name for wholesale and retail sale, and also within within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance, consisting of the price of the producer;
83) equivalence research – research which determines equivalence between generic and original (reference) medicine when using researches in-vivo (in organism) and (or) in-vitro (out of organism);
84) the digital signature (further - the EDS) - set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;
85) pharmaceutical substance (active pharmaceutical substance) – the medicine intended for production and production of medicines.
13. For receipt of the state service "Procedure for Rendering the State Service "Examination, Registration, Re-registration, Modification of the Registration File of Medicine Or Medical Product and Registration of the Price, Modification of the Price of the Producer, and Also Forming of the Kazakhstan National Medicinal Form"" (further – the state service) the applicant (further - uslugopoluchatel) through information system of authorized body submits the application in form, according to appendices 1 and 2 to these rules, signed by the EDS of uslugopoluchatel or certified by the one-time password, in case of registration and connections of subscriber number of the uslugopoluchatel provided by mobile operator to accounting record of information system of authorized body.
14. The name of the state service, the name of the service provider, provision methods, rendering term, form, result of rendering the state service, the working schedule of the service provider and subjects of information, the list of documents and data, claimed at uslugopoluchatel for rendering the state service, the basis for refusal in rendering the state service, established by these rules are provided in the list of the main requirements to rendering the state service (further – requirements to rendering the state service) according to appendix 3 to these rules.
At the same time, the uslugopoluchatel chooses all types of service, included in composite state service, or separately.
15. Uslugopoluchatel agrees to use of the data which are the secret protected by the law, containing in information system of authorized body when rendering the state service if other is not provided by the laws of the Republic of Kazakhstan.
16. Service providers receive digital documents from service of digital documents through the realized integration on condition of the consent of the owner of the document provided by means of the authorized body of subscriber number of cellular communication of the user registered in information system by transfer of the one-time password or departure siding of the short text message as the answer to the notification from information system of authorized body.
17. In case of the address of uslugopoluchatel after the termination of working hours, in days off and holidays according to the labor law, reception of applications and issue of results of rendering the state service is performed the next working afternoon.
18. By provision uslugopoluchately by means of information system of authorized body of the documents provided by the requirement to rendering the state service in "private office" of uslugopoluchatel the status about adoption of the statement for rendering the state service is displayed.
19. Uslugopoluchatel provides reliability, completeness and contents of the provided documents according to the current legislation of the Republic of Kazakhstan and these rules. Provision by uslugopoluchatel of doubtful data is the basis for refusal in rendering the state service.
20. In case of obtaining by uslugopoluchatel of written refusal in rendering the state service, the payment made by it does not return.
21. By results of rendering the state service to uslugopoluchatel one of the documents provided by appendices 4, of 5, of 6, of 7 and 8 these rules or motivated refusal in rendering the state service in the forms provided by appendices 9, of 10, of 11 and 12 these rules which go to "private office" of uslugopoluchatel in electronic form is issued.
22. The term of rendering the state service does not exceed 100 (hundred) working days.
Does not enter terms of rendering the state service:
1) time of completion of shortage of the registration file;
2) provision time uslugopoluchatel of documents and materials on demand on any of examination stages;
3) time of the organization and conducting inspection.
Uslugopoluchatel within 30 (thirty) working days from the date of receipt of the notification on need of conducting inspection provides the letter of consent and provides the statement for conducting inspection in the state expert organization.
Duration of the organization and conducting inspection of production does not exceed 90 (ninety) working days from the date of giving by uslugopoluchatel of the statement on conducting inspection.
The organization and carrying out Advisory council, duration of the organization and carrying out Advisory council does not exceed 4) 30 (thirty) calendar days from the date of the notification of the applicant on removal of materials at Advisory council;
5) coordination by uslugopoluchatel of resulting documents.
23. The claim to the decision, action (failure to act) of the service provider concerning rendering the state service can be submitted addressed to his head, to authorized body by assessment and control of quality of rendering the state services according to the legislation of the Republic of Kazakhstan.
In case of receipt of the claim according to item 4 of Article 91 of the Administrative procedural Procedure Code of the Republic of Kazakhstan (further - APPK RK) the service provider goes to the body considering the claim within 3 (three) working days from the date of its receipt.
The claim of the service provider does not go to the body considering the claim in case of adoption of the favorable act, making of administrative action completely meeting requirements specified in the claim.
24. The claim of uslugopoluchatel according to Item 2 of article 25 of the Law is subject to consideration:
the service provider - within 5 (five) working days from the date of its registration;
authorized body by assessment and control of quality of rendering the state services - within 15 (fifteen) working days from the date of its registration.
25. The term of consideration of the claim by the service provider, authorized body by assessment and control of quality of rendering the state services according to item 4 of article 25 of the Law is prolonged no more than for 10 (ten) working days in need cases:
1) carrying out additional studying or check according to the claim or checks with departure into place;
2) receipts of the additional information.
In case of prolongation of term of consideration of the claim the official given authority on consideration of claims within 3 (three) working days from the moment of prolongation of term of consideration of the claim reports in writing (in case of submission of the claim on paper) or electronic form (in case of submission of the claim in electronic form) to the uslugopoluchatel who made the complaint about prolongation of term of consideration of the claim with indication of the prolongation reasons.
26. If other is not provided by the laws of the Republic of Kazakhstan, appeal in court is allowed after appeal in administrative (pre-judicial) procedure according to Item 5 of article 91 APPK RK.
27. Examination of medicine consists of the following stages:
1) initial examination;
2) specialized examination;
3) laboratory researches.
28. For conducting examination of medicines in case of their state registration and re-registration the uslugopoluchatel by means of information system of authorized body provides the following documents:
1) the statement on conducting examination of medicine (further – the statement) in electronic form in form according to appendix 1 to these rules;
2) the registration file in electronic form in format of the cross-platform electronic document ("pdf" format):
the list of the documents provided for examination by producers of the Republic of Kazakhstan in form according to appendix 13 to these rules;
the list of the documents provided in format of the General technical document in form according to appendix 14 to these rules;
3) the data confirming payment by uslugopoluchatel on the settlement account of the state expert organization of the amount for conducting examination;
4) samples of medicines, standard samples of chemicals, standard samples of biological medicines, test strains of microorganisms, cultures of cages, in the number sufficient for triple laboratory researches and verification of analytical techniques of quality control with residual expiration date at least 9 (nine) months (except as specified, not requiring laboratory testing), and also the specific reagents, consumable materials applied in case of laboratory testing of medicines, the samples of medicines containing drugs, psychotropic substances and precursors, and also requiring special storage conditions (temperature condition, humidity) uslugopoluchatel provides within 2 (two) working days from the moment of filing of application purposely under the delivery-acceptance certificate in test laboratory of the state expert organization.
In case of re-registration of medicines provision of the samples provided by this Item is not required.
5) the list of the provided materials of the registration file depending on type of medicine corresponds to appendix 15 to these rules.
When conducting examination of medicines according to the joint procedure of registration with the World Health Organization (further - WHO) the uslugopoluchatel provides the documents provided in subitems 1), 2) and 3) of this Item of Rules and also:
the letter from WHO on consent in provision of access to materials of the registration file and to the expert report on assessment and reports of pharmaceutical inspectorates;
the declaration on identity (the same production sites of active pharmaceutical substance and ready medicine, identical high-quality and quantitative composition of medicine) of the registration file of the declared medicine prekvalifitsirovanny WHO to medicine or approved by regulatory body with strict regulatory system (SRA) (the USA, EC (EMA), Great Britain, Japan).
29. In case of modification like IA the uslugopoluchatel submits the application in form according to appendix 1 to these rules and documents according to appendix 16 to these rules.
Uslugopoluchatel informs the state expert organization in case of change like IA requiring the immediate notice for the purpose of continuous control of medicine.
The holder of the registration certificate within one statement specifies about several insignificant changes like IA concerning one registration certificate.
In case of modification, the data of the registration certificate requiring change, the state body issues the new registration certificate at former number on residual effective period of the registration certificate.
30. In case of modification like IB the uslugopoluchatel submits the application in form according to appendix 1 to these rules and documents according to appendix 16 to these rules.
Holders of the registration certificate within one statement notify on several changes like IB concerning one registration certificate or to group one or several changes like IB with other changes like IA connected with one registration certificate provided that such group corresponds to the conditions listed in appendix 16 to these rules.
In case of modification, the data of the registration certificate requiring change, the state body issues the new registration certificate at former number on residual effective period of the registration certificate.
31. In case of modification like IB involving other consecutive changes like IA and the IB type one application containing all consecutive changes like I is submitted.
32. In case of introduction of considerable changes like II uslugopoluchatel submits the application in form according to appendix 1 to these rules and documents according to appendix 16 to these rules.
The statement contains one change like II. In case of introduction of several changes like II, the separate application is submitted concerning each change, each statement contains references to other statement;
If change like II leads to other consecutive changes like II, one statement includes all consecutive changes together with the description of compliance between such consecutive changes like II.
If change like II leads to other consecutive changes like I, one statements includes all consecutive changes together with the description of compliance between such consecutive changes like I and II.
Filing of application for examination of modification like IA, IB, II of the registration file is performed by uslugopoluchatel within 3 (three) months after approval of the made changes in the country of the producer or the holder of the registration certificate.
33. In case of modification, requiring new registration of medicine, the uslugopoluchatel submits the application in form according to appendix 1 to these rules with indication of type of the registration procedure and documents according to appendices 13 or 14 to these rules, and also the data confirming payment by uslugopoluchatel on the settlement account of the state expert organization of the amount for conducting examination in case of registration.
34. The accelerated examination of medicines is performed according to the decision of authorized body and carried out in cases:
1) purposes of medicines for prevention, treatment, diagnosis of rare diseases;
2) origins and elimination of consequences of epidemic, pandemic of infectious diseases (the medicines of etiopatogenetichesky therapy applied in emergency situations in response to health hazards of the population (pandemic) and included in clinical protocols of treatment;
3) military operations and liquidation of their consequences, origin, prevention and mitigation of consequences of emergency situations, threat of origin, spread of new especially dangerous infectious diseases and liquidation of their consequences;
4) purposes of medicine, the foreign producer, for transfer of technologies on the production site in the territory of the Republic of Kazakhstan.
When conducting the accelerated examination requirements to safety, quality and efficiency of medicines do not decrease.
35. The joint procedure of registration with WHO is carried out in case of examination of medicines, within the procedure of prekvalifikation and (or) the procedure of recognition of the medicines approved by regulatory body with strict regulatory system (SRA) (the USA, EC (EMA), Canada, Switzerland, Great Britain, Australia, Japan) and performed according to appendices 8 and 11 of Series of Technical reports of WHO, No. 996, 2016. "The procedure of joint registration between group on provisional estimate of the World Health Organization (WHO) and national authorities of regulation for assessment and the accelerated national registration of the pharmaceutical products and vaccines which passed preliminary qualification of WHO".
36. After document registration, 31 and 32 these rules specified in Items 28, of 29, of 30, initial expertize of medicine is carried out:
in case of state registration, re-registration, in case of modification of the registration file, the accelerated registration – within 10 (ten) working days;
in case of the joint procedure of registration with WHO – in time not exceeding 3 (three) working days.
In case of availability of notes the uslugopoluchatel resolves comments within 30 (thirty) working days.
37. In case of initial examination of medicine:
assessment of completeness, completeness and correctness of document creation, provided by uslugopoluchatel in the registration file concerning proofs of safety, quality and efficiency of medicine is carried out;
in case of the statement (new) (production sites) of medicine of the production site pharmaceutical inspection according to the procedure and the terms provided by the Rules of conducting pharmaceutical inspections on proper pharmaceutical practicians approved by the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-9 is appointed new (it is registered in the Register of state registration of regulatory legal acts at No. 22143) (further – the order No. KR DSM-9).
38. In case of non-presentation of the documents provided in Items 28, of 29, of 30, of 31 and 32 these rules, the state expert organization sends to uslugopoluchatel the notification (in any form) about the termination of examination of medicine according to the subitem 1) of item 4 of article 239 of the Code.
39. By results of initial examination of medicine the report of initial examination of medicine according to appendix 17 to these rules or the report of initial examination of the changes made to the registration file of medicine according to appendix 18 to these rules is constituted.
40. The positive result of initial examination of medicine is the basis for conducting specialized examination of medicine.
41. Specialized examination of medicine includes assessment of safety, quality and efficiency and ratio advantage risk of medicine based on the analysis and examination of data in documents of the registration file, the analysis of the report on results of pharmaceutical inspection in case of state registration, re-registration or modification of the registration file of medicines, and also assessment of rationality of combination of active ingredients as a part of medicine according to the List of irrational combinations of medicines according to appendix 19 to these rules.
During conducting specialized examination of medicine authenticity of the translation or the translation into Kazakh of general characteristic of medicine, the instruction on medical application of medicine (leaf insert), prototypes of marking of packaging, labels, stickers with marking is performed.
42. The state expert organization within 10 (ten) working days from the date of the beginning of specialized examination sends to uslugopoluchatel the notification on need of conducting pharmaceutical inspection (in any form) in the following cases:
in case of introduction of new type of medicine (recombinant medicine, medicines of cellular therapy, medicines of gene therapy, the active ingredient which is new chemical compound, blood medicines, the orphan medicine first reproduced or bioanalogue (biosimilyar) on the territory of the Republic of Kazakhstan;
in case of introduction new (new) (production sites) of biological (imunnobiologichesky) active pharmaceutical substance of the production site or clinical center (clinical centers) of the researched medicine;
in case of identification of the facts calling into question reliability of the data provided by uslugopoluchatel in the registration file concerning the conducted preclinical (not clinical) researches (testing) of medicines and clinical trials (testing) of medicines or production of medicine;
in case of attraction of outsourcing services for system of pharmakonadzor of the holder of the registration certificate;
in case of discrepancy of data: absence or insufficiency in the protocol and the report on clinical trial of the data describing measure definition of efficiency and (or) safety;
in case of inclusion in clinical trials of target population (children, patients in critical condition).
43. Specialized examination of medicine is performed by the group of experts of the state expert organization with attraction (in need of) non-staff profile experts.
44. By results of studying of documents of the registration file at stage of specialized examination to uslugopoluchatel the summary inquiry (in any form) is sent by safety, quality and efficiency of medicine:
in case of state registration, including modification, requiring new registration, in case of re-registration, in case of modification of the registration file like _b and type II with laboratory testing – within 60 (sixty) working days;
in case of modification of the registration file like _a, type _b and type II without laboratory testing – within 30 (thirty) working days;
in case of the accelerated medicine registration - within 35 (thirty five) working days;
in case of the joint procedure of registration with WHO - in time not exceeding 5 (five) working days.
The summary request, including notes to general characteristic of medicine, the instruction on medical application of medicine (leaf insert), to prototypes of marking of packaging, labels, stickers with marking, to the regulating document, certified by means of the digital signature goes through information system to uslugopoluchatel to "private office" in day of signing of outgoing request.
45. Uslugopoluchatel directs in full the response and required materials to request of the state expert organization not exceeding 50 (fifty) working days in time.
46. By results of specialized examination in time not exceeding 10 (ten) working days the state expert organization the summary report of experts according to medicine in form according to appendix 20 to these rules is constituted and the summary report of experts in medicine assessment in case of the changes made to the registration file according to appendix 21 to these rules.
In case of examination according to the joint procedure of registration from WHO by results of specialized examination in time not exceeding 3 (three) working days the summary report of experts according to medicine in form according to appendix 20 to these rules is constituted and the summary report of experts in medicine assessment in case of the changes made to the registration file according to appendix 21 to these rules.
47. The bases of creation of the summary report of experts in medicine assessment with the negative decision are:
1) non-presentation of complete set of the registration file after issue of notes to uslugopoluchatel in the course of conducting examination in the terms established by these rules;
2) representation by uslugopoluchatel of false information;
3) the attitude of the expected advantage towards the possible risks connected using medicine is not favorable;
4) lower indicators of quality and safety regulated by the State pharmacopeia of the Republic of Kazakhstan or pharmacopeias, acknowledged acting in the territory of the Republic of Kazakhstan, or in comparison with earlier registered analogs;
5) availability as a part of medicine of the substances and materials forbidden to application in the Republic of Kazakhstan;
6) availability as a part of firm dosage forms of preservatives;
7) receipt of negative results of one of stages of examination and (or) negative expert opinions of the profile organizations;
8) discrepancy of the actual conditions of production and system of quality assurance to the conditions ensuring the declared safety, efficiency and quality by results of assessment of system of quality assurance;
9) refusal of uslugopoluchatel of the organization of visit of the company (production site) for the purpose of assessment of system of quality assurance according to requirements of the legislation of the Republic of Kazakhstan, and also not the organization of pharmaceutical inspection terms, stipulated in Item 42 these rules;
10) identification of irrational combinations of medicines;
11) the uslugopoluchatel does not prove clinical efficiency and safety of medicine;
12) quality of medicine is not confirmed;
13) the proved adverse ratio "advantage risk" or the revealed lack of therapeutic efficiency in case of observance of the conditions of use of medicine described in the approved general characteristic of medicine during the post-registration period;
14) the facts specifying adverse ratio "advantage risk" of medicines, including excess of frequency of reportirovaniye of undesirable reactions in comparison with the data specified in the approved general characteristic of medicine determined according to pharmakonadzor;
15) discrepancy of high-quality and quantitative composition of medicine declared or numerous discrepancy of quality of medicine during its market circulation declared at the time of its registration;
16) failure to carry out by the holder of the registration certificate of obligations on pharmakonadzor;
17) the made changes exert negative impact on ratio "advantage risk" of medicine.
48. Results of the summary report of experts in medicine assessment with the negative decision and materials of the registration file go to Advisory council for decision making.
The advisory council considers the arrived materials monthly, and results of the decision with indication of the reasons go to the applicant within 5 (five) working days.
In case of examination according to the joint procedure of registration from WHO results of the decision with indication of the reasons go to uslugopoluchatel within 2 (two) working days.
49. By results of Advisory council the state expert organization within 5 (five) working days supplements the summary report of experts according to medicine in form according to appendix 20 to these rules and the summary report of experts in medicine assessment in case of the changes made to the registration file according to appendix 21 to these rules.
In case of the joint procedure of registration with WHO the state expert organization within 1 (one) working day supplements the summary report of experts according to medicine in form according to appendix 20 to these rules and the summary report of experts in medicine assessment in case of the changes made to the registration file according to appendix 21 to these rules.
In the report of experts in assessment of medicine all aspects of safety, quality and efficiency of medicine are reflected.
50. Information in IMP (leaf insert) of original medicine, offered for the Republic of Kazakhstan corresponds to information stated in OHLP of the country of the producer or the country of the holder of the registration certificate approved by authorized bodies.
In OHLP, IMP of medicine (leaf insert) is reflected information on excipients, their nominal content in medicines, and also restrictions of use of medicine according to appendix 22 to these rules.
51. OHLP, IMP (leaf insert) of the reproduced, biosimilar medicine corresponds to general characteristic of original medicine. In case of difference in the instruction on medical application (leaf insert) of the reproduced, biosimilar medicine from original medicine according to indications to application towards expansion, or the mode of dispensing or way of introduction results of the corresponding clinical trials are reported.
52. The holder of the registration certificate of original medicine submits the application for modification of IMP (leaf insert) within 70 (seventy) working days after the OHLP updating in the country of the producer or holder of the registration certificate.
53. The state expert organization after modification of the instruction of original medicine or in the absence of registration of original medicine in the Republic of Kazakhstan, in case of identification on the international sources and results of pharmakonadzor about changes in general characteristic of original medicine informs through information resources of all holders of registration certificates of generic medicines on need of entering of corresponding changes into IMP (leaf insert) and OHLP through the procedure of modification of the registration file within 70 (seventy) working days after modification of the instruction of original medicine of information on safety from the date of placement of information on the website of the expert organization.
The holder of the registration certificate of original medicine makes changes to IMP (leaf insert) and OHLP based on the state expert organization of information on the discrepancies revealed as a result of pharmakonadzor and on official international sources within 70 (seventy) working days from the date of placement of information on the website of the expert organization placed on information resource.
Holders of registration certificates submit the application for modification of the registration file within 70 (seventy) working days from the date of placement of the harmonized information on the website of the expert organization for the registered medicines to medicine OHLP and IMP (leaf insert) of medicines with the same international unlicensed name or with the same active ingredient.
54. In case of failure of consideration, specified in Items 52 and 53 of these rules, the state expert organization notifies (in any form) state body on need of suspension of action of the registration certificate.
55. Examination of the changes made to the registration file is performed on medicine during action of the registration certificate and the advantage risk of medicine does not exert negative impact on ratio.
56. Changes are classified according to the List of types of the changes made to the registration file of medicine according to appendix 16 to these rules on:
1) insignificant change like IA – change which exerts the minimum impact or does not exert impact on safety, the quality and efficiency of the registered medicine given to the period of action of the registration certificate of medicine and which is not requiring new registration;
2) insignificant change like IB - change, which not falling under determinations of changes like IA and type II, not requiring new registration;
3) significant change like II - any changes to materials of the registration file which are not requiring new registration of medicine and which exert considerable impact on its safety, quality and efficiency;
4) the changes requiring new registration of medicine;
5) the urgent changes concerning safety of medicine - the urgent temporary restrictions connected with safety of use of medicine which take root uslugopoluchatel in case of identification of risk for public health in case of use of the registered (re-registered) medicine.
The holder of the registration certificate within 24 (twenty four) hours notifies state body on the restrictions introduced by it.
If within 24 (twenty four) watch after receipt of this information from state body objections did not arrive, the emergency restrictions connected with safety are considered as accepted.
Terms of realization of restrictions make a reservation the holder of the registration certificate and state body.
The emergency restrictions connected with safety are initiated by state body with risk for life and health of the person.
The statement on modification, the emergency restrictions concerning introduction (initiated by the holder of the registration certificate or state body), moves the holder of the registration certificate for consideration no later than within 45 (forty five) working days from the moment of the notification.
57. In case of modification which is not classified in these rules the uslugopoluchatel addresses to the state expert organization through the procedure of consultation with the purpose of receipt of the recommendation about change classification.
The state expert organization within 20 (twenty) working days after receipt of request sends the answer to uslugopoluchatel in electronic and (or) paper type.
58. The holder of the registration certificate provides the declaration that in the OHLP and IMP projects of the reproduced, hybrid or biosimilar (biosimilar) medicine there are no differences from the differences of information on the producer, expiration date, composition of excipients and distinctions operating with OHLP and IMP of original (reference) medicine, except for in bioavailability or pharmacokinetics.
59. The holder of the registration certificate provides line-by-line (located in parallel on one leaf) comparison by existing OHLP and IMP of original (reference) medicine and the OHLP and IMP projects of the reproduced, hybrid or biosimilar (biosimilar) medicine with allocation and reasons for all differences.
60. The holder of the registration certificate in case of filing of application on modification of OHLP and IMP provides the sheet of changes with indication of line-by-line located comparison of the text of the made changes with the text of the approved version.
61. The expert organization initiates the procedure of reduction in compliance (harmonization) of information on the registered medicines in OHLP and IMP of medicines with the same international unlicensed name or with the same active ingredient.
62. The holder of the registration certificate in case of development of OHLP and IMP of the reproduced, hybrid or biosimilar (biosimilar) medicine in case of filing of application for examinations in case of registration, and also in case of re-registration and introduction of changes is guided (harmonized) information on OHLP and IMP on the international unlicensed name or composition of the active ingredients posted on the website of the expert organization in the Kazakh and Russian languages brought into accord.
63. Laboratory researches of medicine are performed in terms not exceeding 70 (seventy) working days from the date of receipt of documents for specialized examination in test laboratories of the state expert organization for the purpose of confirmation of conformity of indicators of safety and quality of medicine and include:
1) the analysis of the analytical regulating document of medicine regarding techniques of carrying out testing;
2) laboratory testing on compliance to requirements of the regulating document for quality;
3) determination of reproducibility of analytical techniques of quality control.
Testing of samples of medicines with use of complex of physical and chemical, biological researches is directed to determination of quantitative and qualitative content acting and excipients, impurity, and also degree of biological safety (microbiological purity, toxicity, pirogennost).
64. Laboratory researches are not carried out in case of:
1) medicine re-registrations;
2) to examination of the medicine made according to GMP of the countries of the region of ICH (Aysieych), in the Republic of Kazakhstan according to GMP of the Republic of Kazakhstan and the General technical document having the registration file in format;
3) to examination of medicines, within the procedure of prekvalififikation and (or) the procedure of recognition of scientific assessment of medicines of regulatory bodies with strict regulatory system (SRA) (the USA, EC (EMA), Canada, Switzerland, Great Britain, Australia, Japan) based on the joint procedure of registration with the World Health Organization;
4) to the accelerated examination of medicines.
65. In case of detection of notes in case of laboratory testing within 20 (twenty) working days the letter with indication of the revealed notes and need of their elimination in full in time, not exceeding 30 (thirty) working days is sent uslugopoluchatel to "private office" through information system.
66. In case of not elimination or not complete elimination of notes within 10 (ten) working days from the date of receipt of the answer the state expert organization sends uslugopoluchatel the letter with indication of additional notes and need of their ustraneniye within 20 (twenty) working days.
67. By not provision uslugopoluchately the complete answer to the notes exposed in the letter of the state expert organization and negative results of laboratory researches materials go to Advisory council for decision making about refusal and the termination of examination of medicine according to Item 48 of these rules.
68. By results of laboratory researches of medicine by test laboratory within 10 (ten) working days the test report in form according to appendix 23 to these rules is constituted.
69. Representation of samples, specific reagents and other materials in case of impossibility of carrying out testing in the expert organization is not required owing to:
inaccessibility of samples of medicines of standard samples, specific reagents and other materials (including, in case of their reference to category of the orphan, high-tech, radio pharmaceutical, narcotic, psychotropic or intended for treatment highspending nozologiya owing to their high cost);
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