ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 19, 2009 No. 754

About approval of Rules of creation, coordination and examination of the normative and technical document on control of quality and safety of medicines

According to article 67 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of creation, coordination and examination of the normative and technical document on control of quality and safety of medicines.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan in the established legislation procedure state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work (Bismildin F. B.) provide official publication of this order in mass media, after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of March 28, 2008 No. 159 "About approval of Rules of creation of normative and technical documents on control of quality and safety of medicines (registered in the Register of state registration of regulatory legal acts for No. 5190, No. 69 published in the Yuridicheskaya Gazeta newspaper on May 9, 2008 (1469)).

5. To impose control of execution of this order on the Vice-Minister of Health Birtanov E. A.

6. This order becomes effective after ten calendar days after its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 754

Rules of creation, coordination and examination of the normative and technical document on control of quality and safety of medicines

1. General provisions

1. These rules of creation, coordination and examination of the normative and technical document on control of quality and safety of medicines (further - Rules) establish single requirements to creation, coordination, examination and modification of the normative and technical document on control of quality and safety of medicines.

2. Rules extend to producers of the medicines, their authorized representatives and the organizations of the Republic of Kazakhstan developing, performing examination of the normative and technical document on control of quality and safety of the medicines representing medicine on the state registration / re-registration in the Republic of Kazakhstan.

3. In Rules the following concepts are used:

1) the normative and technical document on control of quality and safety of medicine (further - the specifications and technical documentation) - the document establishing complex of regulations of quality of medicine, the techniques of its determination ensuring equal security and efficiency of medicine irrespective of series and also permanency and uniformity of its production. Treat him: analytical regulating document and temporary analytical document;

2) the analytical regulating document (further - AND) the normative and technical document on control of quality and safety of medicine developed by the manufacturing organizations on industrial series of medicines;

3) the temporary analytical regulating document (further - VAND) the normative and technical document on control of quality and safety of medicine developed by domestic manufacturers on the first trial series of new medicines;

4) group container - the packaging uniting certain amount of medicines in consumer packaging;

5) the owner of the registration certificate - the subject responsible for efficiency, quality and safety of medicine in the territory of the Republic of Kazakhstan;

6) medicine packaging - means or complex of the means ensuring safety of quality of medicine during fixed term of storage, protection of medicine against damages and losses, and also protecting the environment from pollution.

7) standard sample of medicinal substances and foreign impurity (SO) - substance or mix of substances with the established characteristics of the physical, chemical, biological and other properties intended for comparison of quality of the examinee of medicine;

8) the specification of quality - the document containing list of indicators of quality and regulations of their variations, and also references to test methods;

9) examination of the specifications and technical documentation - assessment of degree of compliance of the document of AND (VAND) to mandatory requirements and provisions of regulatory legal acts, state standards, the technical regulations of the Republic of Kazakhstan regulating quality of medicines.

4. In case of state registration, re-registration, modification of the registration file of medicine the state body of control of medical and pharmaceutical activities (further - state body) assigns number specifications and technical documentation, approved by the manufacturing organization.

5. Requirements of these rules do not extend:

1) on the medicinal raw materials of natural origin used for receipt of semi-products in production of medicines;

2) on medical immunobiological supplies, blood donor and its components;

3) on the dosage forms made in the conditions of drugstore.

6. The ANDES (VAND) shall contain list of indicators of quality and technique of testing of quality control of medicine, including alternative and to be developed according to requirements:

1) the State Pharmacopoeia of the Republic of Kazakhstan (further - GF RK);

2) the foreign pharmacopeias recognized acting in the territory of the Republic of Kazakhstan;

3) the state standards, technical regulations and other regulating documents on standardization regulating quality of medicines, techniques of their testing and also packaging, marking and transportation.

7. Quality of medicines shall not be below requirements of GF RK.

8. Effective period of AND is established depending on the technological level of specific production, but no more than five years, effective period of VAND - no more than three years.

9. The ANDES on the medicinal substance and new medicines containing it shall be developed at the same time.

10. The list of the main Sections of AND (VAND) on medicines, and also the sequence of their statement depending on dosage form is given in appendix 1 to these rules.

11. The ANDES (VAND) on homeopathic medicines it is developed depending on structure and type of dosage form.

12. The applicant of medicine provides compliance of content and technical and economic justification of AND (VAND) and changes to them to requirements of the modern level of development of science, the equipment and production, and also the organization of their timely review.

2. Requirements to procedure for creation of AND (VAND)

13. The ANDES (VAND) on medicine it is developed by the applicant under trade name, on medicinal substance under the international unlicensed name (in the presence) or trade name.

14. The ANDES (VAND) shall contain the following structural elements:

1) techniques of testing of medicine and the requirement for the appropriate sections given in Appendix 1 to these rules (further - the Section);

2) the title and last sheets which are drawn up in forms according to appendices 2 and 3 to these rules;

3) the specification of quality which is drawn up in form according to appendix 4 to these rules.

15. Information provided in Sections of AND (VAND) shall conform to requirements of GF RK. Variations from these requirements are reflected in the explanatory note.

16. In the specification of quality and in the text of AND (VAND) numbering of Sections is not designated, separate Sections can unite and if necessary additional Sections can be entered. The description of techniques of preparation of reactants is provided in the Section "Note", examinees of solutions, solutions of comparison, check of suitability of chromotographic system and so forth, the Section heading in the Note is allocated with bold-face type.

17. In the text it is necessary to state: quality requirements of medicine - in imperative form, and techniques of testing - in the third party of plural.

18. It is necessary to specify appointment, type, category, number according to the corresponding register the applied standard samples or designation of the regulating document, or the reference to GF RK.

19. In case of the description of techniques of testing of medicines for the applied reactants, standard solutions, buffer solutions and materials are specified: designations of standards or the specifications (qualification, grade, brand) regulating them, and also the name of the country-manufacturing organization. In the presence of the reactants applied when testing, standard and buffer solutions, and materials in GF RK, their names are italicized and designated by symbol "R". Also names of titrovanny solutions, solutions of comparison, examinees of solutions without designation are italicized by symbol "R".

20. For the applied measuring ware its capacity is specified.

21. Techniques of testing shall be described in detail, including conditions and features of their carrying out.

22. Formulas of calculation shall be provided in the complete and reduced forms, to be followed by the explanation of the physical quantities specified in them. Designations of physical quantities shall be given according to appendix 5 to these rules.

23. For measurement of the physical quantities specified in AND (VAND) the International System of Units (SI), and units allowed to application on an equal basis with it shall be used. In case of designation of physical quantities with decimal signs instead of comma the end is put.

24. The statement of the text shall be short, without repeatings, excluding possibility of various interpretation, is provided with uniform clarity and clearness of letters, figures, signs and lines.

25. Reducing words in the text, texts under drawings, schemes and other illustrations is not allowed, the exception is constituted by the reducings established by GF RK and other state standards.

26. In case of statement of mandatory requirements, regulations and techniques of testing in the text words are applied "shall", "follows", it "is necessary" also derivative of them.

27. In schemes, drawings and illustrations the minimum thickness of lines, size of gleams, the sizes of figures, clarity of graphical representations shall be observed.

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