Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of January 27, 2021 No. KR DSM-10

About approval of rules of conducting examination of medicines and medical products

(as amended on 20-12-2021)

According to items 4 and the 10th Articles 23, Item 3 of article 239 of the Code of the Republic of Kazakhstan "About health of the people and health care system" and the subitem 1) article 10 of the Law of the Republic of Kazakhstan "About the state services" PRIKAZYVAYU:

1. Approve:

1) rules of conducting examination of medicines according to appendix 1 to this order;

2) rules of conducting examination of medical products according to appendix 2 to this order.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 3 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) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

It is approved

Ministry of digital development, innovations and aerospace industry of the Republic of Kazakhstan

 

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-10

Rules of conducting examination of medicines

Chapter 1. General provisions

1. These rules of conducting examination of medicines (further - Rules) are developed according to items 4 and the 10th Article 23 and Item 3 of article 239 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further - the Code), article 14 of the Law of the Republic of Kazakhstan "About the state services" (further - the Law) and determine procedure for conducting examination of medicine, and also procedure for rendering the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products".

2. Expertize of medicines according to Item 2 of article 239 of the Code is carried out by the state expert organization in the sphere of drug circulation and medical products performing production economic activity in the field of health care on safety, efficiency and qualities of medicines based on the contract for conducting examination of medicine signed with the applicant.

Payment of cost of examination of medicine is performed according to the price list established by authorized body in coordination with antimonopoly authority according to Item 2 of article 239 of the Code.

3. The medicines made in the Republic of Kazakhstan, and also imported on its territory are subject to examination.

4. Expertize is not carried out on medicines under one trade name, the active agents having various high-quality structure. Examination on the medicines made in the Republic of Kazakhstan for export is carried out according to the decision of producers of the Republic of Kazakhstan.

5. Before filing of application for examination the applicant on own initiative receives in the state expert organization scientific and preregistration consultations on contractual basis on the questions connected with conducting examination.

6. The state expert organization involves experts from the profile organizations performing activities in the sphere of service of blood to conducting examination of medicines of blood and components of blood.

7. In these rules the following terms and determinations are used:

1) 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;

2) bioavailability - the speed and degree with which active agent is soaked up from dosage form and becomes available in the scene of action;

3) 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;

4) 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;

5) 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;

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) 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;

8) 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);

9) 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;

10) 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;

11) 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;

12) 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;

13) irrational combination of composition of medicines - the composition of medicine which is not corresponding to expected pharmacological properties and action;

14) the instruction on medical application of medicine (leaf insert) - the document containing information for the consumer and accompanying medicine in packaging;

15) 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;

16) standard samples of medicinal substances and their impurity - the comparison substances used when conducting examination of examinees of medicines;

17) producer of medicines - the organization which is performing activities for production of medicines and having the license for production of medicines;

18) 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;

19) general characteristic of medicine - 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;

20) 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;

21) medicines of the advanced therapy (further - LPPT) - the medicines of medical application which are medicines of gene therapy, therapy by somatic cages, fabrics - engineering medicines or the combined medicines for the advanced therapy;

22) 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;

23) the risk management plan - the detailed description of risk management system;

24) 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;

25) 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;

26) 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));

27) 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 medicine or medical product and to acceptance of the final decision;

28) 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;

29) 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;

30) the applicant - the developer, the producer, 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 in case of registration, re-registration and modification of the registration file of medicines;

31) 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;

32) reference medicine - medicine which is used as medicine of comparison and is standard by which are determined properties of medicine (are normalized);

33) 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;

34) the registration file - the set of documents and materials of the established content represented to the statement for examination;

35) 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;

36) modification of the registration file - the changes made by the applicant to the registration file during action of the registration certificate, which are not influencing negatively safety, quality and efficiency of medicine and subject to examination according to these rules;

37) pharmaceutical substance (active pharmaceutical substance) - the medicine intended for production and production of medicines;

38) 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);

39) medicinal vegetable medicine - the medicine containing in quality of active components exclusively medicinal vegetable raw materials and (or) medicines on its basis;

40) 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.

41) 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);

42) 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;

43) the state expert organization in the sphere of drug circulation and medical products (further - the expert organization) - 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.

Chapter 2. Procedure for provision of the registration file for conducting examination of medicines

8. For conducting examination of medicine and receipt of the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products" (further - the state service) the applicant through information system of the state expert organization (further - information system) or the portal of "the electronic government" (www.egov.kz) provides the following documents and materials:

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 2 to these rules;

the list of the documents provided in format of the General technical document in form according to appendix 3 to these rules;

3) the data confirming payment by the applicant 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 quantities sufficient for triple laboratory researches 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 applicant provides within 5 (five) working days from the moment of filing of application purposely under the delivery-acceptance certificate in Service center of applicants (further - TsOZ) to the state expert organization.

The samples of medicines containing drugs, psychotropic substances and precursors, and also requiring special storage conditions (temperature condition, humidity) are provided by the applicant under the delivery-acceptance certificate directly in test laboratory of the state expert organization.

The list of the provided materials of the registration file depending on type of medicine corresponds to appendix 4 to these rules.

9. In case of emergency situations of natural or technogenic nature, the organization and holding sanitary and anti-epidemic and sanitary and preventive actions and related restrictive actions, including quarantine, in case of filing of application for examination in case of registration, re-registration or modification of the registration file the applicant provides as a part of the registration file the guaranty letter about provision of the documents requiring notarial assurance or apostilization before completion of stage of specialized examination. In case of not provision of the certified or apostilled documents, expert works stop.

10. For examination of various dosage forms of the same medicine the applicant submits applications and registration files on each dosage form. On condition of simultaneous giving for examination of medicine in one dosage form, with various dosage, concentration, filling amount the applicant submits one application and the registration file with appendix of prototypes of packagings and labels on each dosage, concentration, amount of filling and quantity of doses in packaging, and also the regulating document on quality in case of distinction in control techniques.

11. In case of provision of the reproduced, biosimilar medicine by domestic manufacturer for examination without these researches of equivalence including which are at examination stage, the applicant in the registration file provides:

1) permission to performing clinical trial and (or) testing pharmacological and medicines, issued by authorized body;

2) copy of the notification (any form) on the beginning of clinical trial pharmacological and medicines.

12. In case of examination of orphan medicines the applicant reports the research program which results are the basis for revaluation of ratio "advantage risk", with observance of use of medicine under strict observation of the doctor and immediate provision of maps messages about undesirable reactions, serious undesirable reactions and about lack of efficiency of medicine in compliance the rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products approved by the order of the Minister of Health of the Republic of Kazakhstan of December 23, 2020 No. KR DSM-320/2020 (it is registered in the Register of state registration of regulatory legal acts at No. 21896).

13. The list of the main requirements to rendering the state service including characteristics of process, form, content and result of rendering and also other data taking into account features of provision of the state service is provided in the Standard of the state service according to appendix 5 to these rules (further - the Standard).

14. Confirmation of adoption of documents through information system is display in "private office" of the applicant of the status about acceptance of request for rendering the state service.

In cases of submission of documents by the applicant through the portal in "private office" the status about acceptance of request for rendering the state service with indication of date and the place of receipt of result of the state service is displayed.

The data on the identity document, or the electronic document from service of digital documents (for identification) about state registration (re-registration) of the legal entity, the certificate on state registration of the applicant as the individual entrepreneur containing in the state information systems, the state expert organization receives from the corresponding state information systems through lock "the electronic government.

15. The statement and documents, stipulated in Item 8 these rules by means of information system arrive on processing in TsOZ.

The authorized employee of TsOZ by means of information system distributes the arrived statements to the executive in charge. In case of receipt of the statement after the termination of working hours, in days off and holidays according to the labor law of the Republic of Kazakhstan, reception of an application is performed the next working afternoon.

The executive in charge of TsOZ after documents acceptance, stipulated in Item 8 these rules within one working day:

1) performs registration of a statement in information system;

2) posts information on the official site of the state expert organization on the medicines (the trade name, the international non-proprietary name, dosage form, dosage, concentration, the manufacturing organization, the country) given for examination;

3) is checked by residual expiration date of samples of medicines, standard samples of chemicals, standard samples of biological medicines, test strains of microorganisms, cultures of the cages, specific reagents, consumable materials necessary for reproducibility of techniques of laboratory researches of medicine and enters data into information system.

16. In cases not of observance of conditions, stipulated in Item 8 these rules the executive in charge of TsOZ within two working days sends by means of information system to "private office" of the applicant the notification on refusal in reception of an application certified by the electronic and digital signature of the authorized employee of TsOZ in form according to appendix 6 to these rules.

17. The state expert organization provides entering of data on stage of rendering the state service into information system of monitoring of rendering the state services according to the subitem 11) of Item 2 of article 5 of the Law and quarterly, no later than the 25th day of the first month of the next quarter, sends the relevant information to state body.

Chapter 3. Procedure for conducting examination of medicines

18. Examination of medicine consists of the following stages:

1) initial examination;

2) specialized examination;

3) laboratory researches.

19. Expertize is carried out with use of the electronic program of the state expert organization integrated with the single database "Management System of Provision of Medicines" of the Unified information system of health care.

The applicant obtains information on procedure and the status of rendering the state service in the mode of remote access by means of "private office" of information system of the state expert organization, and also single contact - the center for questions of rendering the state services.

At the same time the applicant's term on provision of the answer and required materials on requests of the expert organization is estimated of signature date of the outgoing request certified by the electronic and digital signature.

20. In case of failure in work of information system or the portal in case of filing of application and the registration file on examination or by provision of documents on request of the expert organization at stage of expert works, the applicant informs service of technical support of the state expert organization or the operator of information and communication infrastructure of "the electronic government" by means of provision by e-mail of requisition number and step-by-step screenshots from the moment of authorization until emergence of mistake with indication of the exact time of mistake.

Paragraph 1. Procedure for conducting initial examination of medicines

21. After registration of a statement and acceptance of the registration file in TsOZ initial expertize of medicine in the terms provided by Chapter 6 of these rules is carried out.

22. In case of initial examination of medicine assessment of completeness, completeness and correctness of document creation, provided by the applicant in the registration file concerning proofs of safety, quality and efficiency of medicine is carried out.

23. In case of availability of notes to documents of the registration file to the applicant through information system the inquiry (in any form), certified by the electronic and digital signature, with indication of the revealed notes and need of their elimination in full in time, not exceeding sixty calendar days is sent to "private office".

24. In case of not elimination of notes and non-presentation of the answer at the scheduled time, stipulated in Item 23 these rules, the state expert organization sends to the applicant 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.

25. By results of initial examination of medicine the report of initial examination of medicine according to appendix 7 to these rules or the report of initial examination of the changes made to the registration file of medicine according to appendix 8 to these rules is constituted.

Paragraph 2. Procedure for conducting specialized examination of medicines

26. The positive result of initial examination of medicine is the basis for conducting specialized examination of medicine in the terms provided by Chapter 6 of these rules.

27. 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, including results of laboratory researches of samples of medicine, the analysis of the report on results of pharmaceutical inspection in case of state registration 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 9 to these rules.

28. 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.

29. By results of studying of documents of the registration file at stage of specialized examination to the applicant the summary inquiry (in any form) is sent by safety, quality and efficiency of medicine.

The summary request, including notes to general characteristic of medicine, the instruction on medical application (leaf insert), to prototypes of marking of packaging, labels, stickers with marking, to the regulating document, certified by means of the electronic and digital signature goes through information system to the applicant to "private office" in day of signing of outgoing request.

30. The applicant within sixty calendar days directs in full the response and required materials to request of the state expert organization.

In case of the additional questions concerning the data provided by the applicant in the response to prior request, the applicant within thirty calendar days from the moment of receipt of request directs the response and required materials to additional request of the state expert organization.

30-1. By not provision by the applicant of replies to the request of the state expert organization at the scheduled time according to Item 30 of these rules, and also provision of the incomplete answer and required materials, the state expert organization constitutes the negative summary report of experts in medicine assessment.

30-2. In case of pronouncement of the negative summary report on the bases specified in Item 30-1 of these rules, the state expert organization not later than 3 (three) working days before completion of term of rendering the state service according to Article 73 of the Administrative procedural Procedure Code of the Republic of Kazakhstan (further - APPK RK) the notification on the provisional solution on refusal in rendering the state service (in any form), and also time and the venue of hearing for opportunity to express to the applicant line item according to the provisional solution sends to the applicant.

The procedure of hearing is carried out according to article 73 APPK RK.

31. By results of hearing materials go to Advisory council for decision making about refusal and the termination of examination of medicine, or about issue of the conclusion about safety, quality and efficiency of medicines in forms according to appendices 14, 15 to these rules.

The advisory council considers the arrived materials monthly, and results of the decision with indication of the reasons go to the applicant within ten calendar days.

32. By results of specialized examination the Summary report of experts according to medicine in form according to appendix 10 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 11 to these rules. In the report of experts in assessment of medicine all aspects of safety, quality and efficiency of medicine are reflected.

In case of negative results of examination the expert organization sends to the applicant the decision of Advisory council with indication of the reasons.

Paragraph 3. Procedure for laboratory testing of medicines

33. In case of the positive report of specialized examination laboratory researches of medicine are carried out to the terms provided by Chapter 6 of these rules.

34. Laboratory researches of medicine are performed 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) testing of samples of medicine;

3) determination of reproducibility of analysis techniques.

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).

Determination of reproducibility of analysis techniques on quality control of medicine is performed for the purpose of confirmation of their compliance, provided by the regulating document on quality.

35. Laboratory researches are not carried out in case of:

1) medicine re-registrations;

2) to examination of the medicine made in the countries of the region of ICH (Aysieych), in the Republic of Kazakhstan according to GMP PK and the General technical document having the registration file in format;

3) to examination of medicines, prekvalifitsirovanny World Health Organization;

4) to the accelerated examination of medicines.

36. In case of detection of notes in case of laboratory testing the letter with indication of the revealed notes and need of their elimination in full in time, not exceeding ninety calendar days is sent the applicant to "private office" through information system.

37. By not provision by the applicant of answers the notes exposed in the letter of the state expert organization at the scheduled time according to Item 36 of these rules and negative results of laboratory researches materials go to Advisory council for decision making about refusal and the termination of examination of medicine.

38. By results of laboratory researches of medicine by test laboratory the test report in form according to appendix 12 to these rules is constituted.

39. In cases of impossibility of laboratory testing of samples of medicines in test laboratory of the state expert organization, including in case of their reference to category of the orphan, narcotic, psychotropic or intended for treatment highspending nozologiya owing to their high cost, impossibility of observance of conditions of transportation of the specified samples on the territory of the Republic of Kazakhstan and (or) their storage, lack of the special equipment and consumable materials in the expert organization and in cases if regulating documents on product quality establish the testing connected with big costs of means of the producer, high cost of samples with the samples requiring special conditions of transportation, the specific equipment and supportive applications laboratory researches are carried out in the presence of representatives of the expert organization in laboratory of quality control of the producer or in contractual laboratory, used by the producer.

By results of laboratory researches the Report on results of conducting laboratory research in laboratory of quality control of the producer or in the contractual laboratory used by the producer according to appendix 13 to these rules is constituted.

40. In case of impossibility of laboratory testing of medicine on separate indicators, the laboratory of the expert organization recognizes results of laboratory researches on the separate indicators specified in the certificate (protocol) of the analysis of the producer according to the decision of Advisory Council.

Chapter 4. Procedure for forming of results of the carried-out expertize of medicines

41. Upon termination of examination (initial examination, specialized examination and laboratory researches) the applicant within thirty calendar days which are not entering in time conducting examination approves with the state expert organization in electronic form for the individual password through private office or by provision of leaf of coordination the general (administrative) information about medicine, resulting documents (the regulating document on quality, the instruction on medical application and prototypes of marking of packaging, labels, stickers with marking), including correctness of the entered data and in case of detection of discrepancy of updating of resulting documents.

Coordination is performed in electronic form according to the individual password through private office or by provision of leaf of coordination.

In case of lack of coordination by the applicant after thirty calendar days from end date of examination of data on medicine, the conclusion about safety, quality and efficiency of medicine is created without its coordination.

42. By results of the carried-out medicine expertize the state expert organization constitutes the conclusion about safety, quality and efficiency of the medicine declared for examination according to appendix 14 to these rules and the conclusion about safety, quality and efficiency of the medicine declared for examination of the changes made to the registration file according to appendix 15 to these rules.

The result of the state service goes to the applicant to "private office" through information system or the portal in electronic form, certified by the digital signature (further - the EDS) the authorized person of the state expert organization.

43. The state expert organization sends the head, in electronic form with the electronic and digital signature (or the authorized person) and the responsible persons who were carrying out expertize to state body:

conclusion about safety, quality and efficiency of medicine;

the general characteristic of medicine, the instruction on medical application of medicine (leaf insert) in the Kazakh and Russian languages developed according to procedure stipulated in Item 4 articles 242 of the Code and approved by the expert organization;

prototypes of packagings, labels, medicine stickers, in the Kazakh and Russian languages, approved by the expert organization.

44. Conclusion about safety, quality and efficiency of medicine really hundred eighty calendar days. In case of expiration of the conclusion, the applicant repeatedly submits the application, documents and materials for conducting examination of medicine, provided in Item 8 of these rules.

45. For the medicines of national production made for export and the domestic market of the country under different trade names, expertize is carried out with issue of one conclusion of safety, quality and efficiency of medicine.

46. The bases of issue of the negative conclusion about safety, efficiency and quality of medicine are:

1) non-presentation of complete set of the registration file after issue of notes to the applicant in the course of conducting examination in the terms established by these rules;

2) submission of false information by the applicant;

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 the applicant 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;

10) identification of irrational combinations of medicines;

11) the applicant 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.

47. In cases of the negative conclusion about safety, quality and efficiency of medicine or response the applicant of the statement for examination after the beginning of conducting examination, the cost of carrying out expert works to the applicant does not return.

48. By results of examination the state expert organization creates the summary report on safety, quality and efficiency of medicine according to appendix 16 to these rules which not confidential part is placed on Internet resource of the state expert organization.

49. After examination completion of the procedure the state expert organization creates the electronic archival copy of the registration file containing documents and materials of result of examination (the additional materials provided by the applicant at the request of the state expert organization, the conclusion of initial examination (validation of the registration file), the final summary report of experts in critical evaluation of medicine, protocols of test laboratory), the conclusion about safety, to quality and efficiency, general characteristic of medicine, the instruction on medical application (leaf insert), the regulating document on quality of medicines, the registered prototypes of packagings, labels, stickers which are stored in electronic archive.

During action of the registration certificate the archival registration file, is supplemented with the registration file submitted on modification, containing documents and materials of results of examination.

The registration file is stored in electronic archive on the electronic medium within ten years.

Chapter 5. Features of conducting examination of medicines

50. The explanations or amendments arising during conducting examination between the state expert organization and the applicant are performed by forming of the electronic document according to the individual password of the applicant through information system with the electronic and digital signature of the applicant and the state expert organization.

For the period of provision by the applicant of required documents examination stops.

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.