ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 26, 2015 No. 524

About modification and amendments in the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 736 "About approval of Rules of conducting examination of medicines, products of medical appointment and medical equipment"

According to article 63 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 736 "About approval of Rules of conducting examination of medicines, products of medical appointment and medical equipment" (registered in the Register of state registration of regulatory legal acts for No. 5926, published in the Collection of acts of the central executive and other central state bodies of the Republic of Kazakhstan, No. 5, 2010) the following changes and amendments:

in Rules of conducting examination of the medicines approved by the specified order (further - Rules):

be reworded as follows Item 2:

"2. Examination of medicines belongs to the state monopoly, is performed by the republican state company on the right of economic maintaining which is the state expert organization in the field of drug circulation, products of medical appointment and medical equipment - the Republican state company on the right of economic maintaining "The national center of examination of medicines, products of medical appointment and medical equipment" of the Ministry of health and social development of the Republic of Kazakhstan (further - the state expert organization) and conducted in the Examination of Medicines Program of the state expert organization with use of the single database of the Management system of provision of medicines of the Unified information system of health care (further - SULO).";

4, of 5, of 6, 7 to be reworded as follows Items:

"4. Information on the medicine given for examination for carrying out state registration, re-registration and modification of the registration file and also examination is confidential information.

Persons having access to the confidential information relating to examination of medicines keep its confidentiality.

5. Payment of cost of examination of medicine in case of registration, re-registration and modification of the registration file is made by the applicant into the account of the state expert organization according to article 63 of the Code of the Republic of Kazakhstan "About health of the people and health care system.

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

1) the authorized generic (autogeneric) - the medicine identical to the registered medicine issued by the same producer, but differing in trade names and the price;

2) equivalence research - research which determines equivalence between generic and reference medicine when using researches in-vivo (in organism) and (or) in-vitro (out of organizam);

3) bioequivalence - the comparative characteristic of two medicines under identical conditions which confirms their pharmaceutical and biological equivalence concerning efficiency and safety after use in identical molar doses;

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;

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) medicines of biological origin - the medicines containing biological substances (hormones, cytokines, the fibrillation factors, insulin, monoclonal antibodies, enzymes, colony stimulating factors, medicines created based on cells of fabrics, and other, received by means of biotechnological methods);

7) биосимиляр - biotechnological medicine, similar with (original) medicine made for the first time on quality, safety, efficiency and provided on registration after expiration of the patent of original medicine;

8) biotechnological medicine - the biological medicine made by bioengineering procedures using technology of recombinant deoxyribonucleic acid, method of controlled expression of the genes coding development of biologically active proteins, method of hybrid and monoclonal antibodies and also gene therapeutical and somatotherapeutical medicines of genetically engineered modification;

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) equivalence research in-vitro based on BSK - the complex research which is based on classification of active agent according to BSK and medicine dissolution and also includes comparison of profiles of dissolution of generic and reference medicine in three circles;

11) homeopathic medicines - the medicines containing substances of natural origin in small doses and made on special technology;

12) medicine - the means representing or containing pharmacological the active agents coming into contact with human body or getting into its bodies and fabrics intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal raw materials, balk-products of medicines, medicines;

13) safety of medicines - lack of the unacceptable risk connected with possibility of harming of life, to health of the person and the environment;

14) the instruction on medical application of medicine - the approved information on medical application of medicine in the Republic of Kazakhstan;

15) the conclusion about safety, efficiency and quality of medicine - the document containing results of examination of the declared medicine and the recommendation of possibility of state registration, re-registration, modification of the registration file or about refusal in holding the corresponding procedures;

16) the regulating document on control of quality and safety of medicines - the document establishing complex of the quality requirements of medicine, and also to techniques of its determination providing their identical parameters of safety and qualities;

17) the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the state expert organization) - the organization determined by authorized body in the field of health care for conducting examination of medicines, products of medical appointment and medical equipment;

18) medicinal substance - substance or mix of substances, regardless of the origin nature, having certain pharmacological activity, intended for production and production of medicines;

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

20) efficiency of medicines - set of the characteristics providing achievement of preventive, diagnostic, medical and (or) rehabilitation effect;

21) the manufacturing organization of medicine - the individual entrepreneur or the legal entity performing production or one or several production stages;

22) medicinal vegetable raw materials - the fresh or dried-up plants or their parts used for production or production of medicines;

23) the reproduced medicine (generic) - the medicine identical to original medicine on composition of active substances, dosage form, indicators of quality, safety, efficiency issued by different producers;

24) well studied medical application - medical application of the active agent which is part of medicine which efficiency is well studied, acknowledged degree of safety it is acceptable and confirmed with detailed bibliographic references to the published data on postregistration, epidemiological researches, and there passed at least 15 years from the date of the first systematic and documentary use of medicine;

25) the applicant - the developer, the manufacturing organization, the holder of the registration certificate or their authorized representative, authorized to submit the application, documents and materials for conducting examination of medicines for their state registration, re-registration, modification of the registration file;

26) parapharmaceutics - biologically active agents of natural origin or their synthetic analogs in medical doses having pharmacological action and directed to prevention of diseases, auxiliary therapy and regulation of functional activity of bodies and systems;

27) the generator radionuclide - the system containing the fixed primary (parent) radionuclide of which the secondary (affiliated) radionuclides which are extracted by eluating or in a different way and applied to diagnostics or treatment of disease are formed;

28) radionuclide set (whale) - medicine which shall be integrated or mixed with radionuclide or radionuclides in ready radio pharmaceutical medicine, as a rule, before its application;

29) radionuclide precursor - the radionuclide intended for introduction of radioactive tag in other substance before its application;

30) radio pharmaceutical medicines - the medicines containing one or several radionuclides (radioactive isotopes) and applied to diagnostics and treatment of disease. Generators radionuclide, radionuclide set, radionuclide precursor belong to radio pharmaceutical medicines;

31) reference medicine - the original medicine intended for comparison with it of generic or biosimilyar;

32) the registration file - the set of documents and materials of the established content represented to the statement for examination based on which the valid conclusion about efficiency, safety and qualities of medicine is drawn;

33) 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, efficiency and quality of medicine and subject to examination;

34) the holder of the registration certificate - developer, the manufacturing organization, the organization having the document from the producer on right of possession the registration certificate bearing responsibility for safety, efficiency and quality of medicine;

35) 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;

36) the certificate on pharmaceutical product (CPP) - the document issued by authorized body for registration of domestic medicines abroad and their export;

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

7. The medicines registered in the manufacturing country and (or) in the country holder of the production license, and (or) in the country owner of the registration certificate, except for intended for prevention and treatment of the socially important and orphan diseases which do not have registration (in the presence of reasons) in the manufacturing country and (or) in the country holder of the production license, and (or) the country owner of the registration certificate are subject to examination in case of state registration in the Republic of Kazakhstan.";

add with Item 12-1 of the following content:

"12-1. Before filing of application for examination the applicant at will receives in the state expert organization scientific and preregistration consultation on paid basis on all questions connected with conducting examination in case of state registration of medicines.";

be reworded as follows Item 13:

"13. Examination of medicines in case of state registration, re-registration, modification of the registration file is carried out based on the statement on conducting examination of medicine in the Republic of Kazakhstan according to appendix 1 to these rules, the agreement signed between the applicant and the state expert organization on conducting examination.

Are enclosed to the application:

1) the registration file containing the documents and materials specified in the List of the documents of the registration file provided in case of examination of the medicines in the Republic of Kazakhstan made not in the conditions of the Proper production practice) according to appendix 2 (further - the List) and in the List of the documents of the registration file provided in case of examination of medicines to the Republic of Kazakhstan in format of the General technical document (for the medicines made in the conditions of the Proper production practice) according to appendix 3 to these rules (further - the OTD format). The registration file is provided on the electronic medium in format of the cross-platform electronic document (pdf format);

2) samples of medicines, standard samples of medicinal substances and their impurity in the quantities sufficient for the triple analysis;

3) the specific reagents, consumable materials applied when carrying out testing of medicines (in exceptional cases and on terms of return);

4) the notarized copy of the security document for the invention or useful model of original medicine (it is provided by the patentee of the security document);

5) the commitment letter about non-infringement of exclusive rights by the third parties on the invention or useful model (it is provided in case of state registration, re-registration of generic medicine).

The state expert organization enters information about availability of the security document for the invention or useful model of original medicine in the Examination of Medicines program.";

be reworded as follows Item 16:

"16. The registration file on the medicine made in the conditions of the Proper production practice is constituted on the OTD format.

The registration file in the OTD format is constituted:

1) manufacturing organizations of foreign countries;

2) the manufacturing organizations of the CIS countries - in two years after receipt of the certificate of the Proper production practice; the manufacturing organizations of the Republic of Kazakhstan - in four years after receipt of the certificate of the Proper production practice.

3) the manufacturing organizations of the Republic of Kazakhstan - till 2025.";

be reworded as follows Item 20:

"20. On condition of simultaneous giving for examination of one dosage form (for the medicines of national production made for the domestic market of the country and intended for export - different trade names), with different 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 control of quality and safety in case of distinction in control techniques.";

be reworded as follows Item 22:

"22. Materials of Modules 4 and 5 of the OTD format and parts 3 and 4 of the List shall conform to requirements to materials of the registration file according to appendix 4 to these rules;

the instruction on medical application of medicine is developed on each dosage form;

in the instruction information on excipients, admissible limits of their content in medicines according to appendix 5 to these rules is reflected.";

be reworded as follows Item 25:

"25. From the applicant having the document confirming production compliance to proper production practice of the Republic of Kazakhstan, the countries regions of the International conference on harmonization of technical requirements to registration of medicines for the person (ICH) (further in the text - ICH), the International system of cooperation of pharmaceutical inspections (PIC/S) does not need provision of reports of researches of equivalence in organism (ин виво) provided that:

1) medicines for parenteral application (intravenously, hypodermically or intramuscularly) in the form of the water solutions containing identical high-quality and quantitative composition of active agent, as reference medicine with identical or similar excipients in the concentration compared to reference medicine. At the same time, some excipients (in particular buffer solutions, preservatives, antioxidants) can differ on condition of the proof in any manner that in these concentration they do not influence safety and (or) efficiency of medicine (exception - medicines of iron, amino acids, derivatives of starch, gelatin, complexing medicines);

2) medicines for intake and the identical high-quality and quantitative compositions of active agent, as reference medicine applied in the form of water solutions, containing, with identical or similar excipients in the compared reference medicines;

3) medicines in the form of powders for preparation of water solutions if solution meets the requirements of subitems 1 or 2 of this Item;

4) medicines which are gases;

5) the ear or eye medicines made in the form of the water solutions containing identical high-quality and quantitative composition of active agents, as reference medicine with identical or similar excipients in the concentration compared to reference medicine. At the same time, some excipients (in particular the buffer solutions, preservatives, substances adjusting density, or thickeners) can differ on condition of the proof in any manner that in these concentration they do not influence safety and (or) efficiency of medicine;

6) medicines of local action in the form of the water solutions containing identical high-quality and quantitative composition of active agents, as reference medicine with identical or similar excipients in the concentration compared to reference medicine;

7) medicines which are water solutions and are intended for inhalations by the nebulizer or in the form of nasal sprays, the deliveries of medicine applied by means of almost identical devices and the containing identical high-quality and quantitative compositions of active agents, the same excipients in comparable concentration, as reference medicine. At the same time, some excipients can differ on condition of the proof in any manner that in these concentration they do not influence safety and (or) efficiency of medicine (exception - the medicines containing hormones, medicines with antiobstructive action);

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