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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 29, 2019 No. KR DSM-57

About approval of Rules of development, registration, modification, coordination, approval and enforcement of the State pharmacopeia of the Republic of Kazakhstan

According to Item 7 of article 66-1 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 development, registration, modification, coordination, approval and enforcement of the State pharmacopeia of the Republic of Kazakhstan.

2. To provide to committee of pharmacy 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) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

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

4) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

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

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

No. KR DSM-57 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of April 29, 2019

Rules of development, registration, modification, coordination, approval and enforcement of the State pharmacopeia of the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules establish procedure for development, registration, modification, coordination, approval and enforcement of the State pharmacopeia of the Republic of Kazakhstan.

2. For the purposes of this document concepts which mean the following are used:

1) the main pharmacopeias of the world - pharmacopeias which standards are the basis for the State pharmacopeia of the Republic of Kazakhstan (further - GF RK). The European pharmacopeia, the British pharmacopeia and pharmacopeia of the United States of America belong to the leading pharmacopeias of the world (further - the Pharmacopoeia of the USA). At the same time the European pharmacopeia is basic pharmacopeia for GF RK (further - basic pharmacopeia)

2) the general monograph (general pharmakopeyny clause) - the pharmakopeyny Article containing general requirements and provisions on quality and packaging of medicines and other products for pharmaceutical application and also to testing and methods of their carrying out;

3) the private monograph (private pharmakopeyny Article) - the pharmakopeyny Article containing private quality requirements of specific medicines and other products for pharmaceutical application;

4) the State pharmacopeia of the Republic of Kazakhstan - the code of the minimum requirements to safety and quality of medicines and medical products.

Chapter 2. Procedure for development of the State pharmacopeia of the Republic of Kazakhstan

3. Development of GF RK is performed on the basis of the following principles:

1) harmonization with the leading pharmacopeias of the world, and also the international and interstate standards on medicines and medical products (further - the leading pharmacopeias of the world);

2) updating in connection with the current editions of the main pharmacopeias of the world, changes in the pharmaceutical market of the Republic of Kazakhstan and new quality requirements of medicines;

3) continuity of development and enhancement of pharmakopeyny requirements on the basis of modern scientific knowledge and technique of analytical experiment.

4. Harmonization of GF RK is performed on perspective and retrospective types. Perspective harmonization is carried out for medicines and separate types of medical products, and also methods of their testing which were earlier not subject of pharmakopeyny standardization. Retrospective harmonization is carried out for the Sections and monographs included in pharmacopeia.

5. Harmonization of GF RK is performed with use of the complete and selective (partial) mechanism of borrowing. The complete mechanism provides the borrowing in full excluding any essential changes. The selective (partial) mechanism comes down to the borrowing of the assorted parts assuming the approved changes.

6. The complete mechanism of harmonization of GF RK is performed by the following methods:

1) copying of texts of basic pharmacopeia;

2) adaptivising of texts of basic pharmacopeia for simplification of their understanding;

3) inclusion (incorporation) in content of GF RK of own texts.

7. The selective (partial) mechanism of harmonization of GF RK allows to use other methods of harmonization. At the same time the borrowed and own text shall be approved among themselves.

8. The complete mechanism is used in case of harmonization of GF RK with standards of basic pharmacopeia. In case of harmonization with the British pharmacopeia and the Pharmacopoeia of the USA it is used both complete, and selective (partial) mechanisms.

9. Monographs (Article) borrowed from the leading pharmacopeias of the world contain both theoretical provisions, and techniques of testing. Borrowing of techniques of the testing given in texts of the leading pharmacopeias of the world does not require their validation.

10. Style of statement of the monograph (Article) of GF RK, the name of Sections shall correspond to basic pharmacopeia.

11. Own (national) monographs (Articles) of GF RK can be presented in the form:

1) national monograph;

2) separate national part in structure of the monograph;

3) the fragments included (incorporated) in the borrowed texts of the monograph (Article).

12. Inclusion of own texts in the form of separate national part, is possible in cases of copying and adaptivising of texts of the leading pharmacopeias of the world. National part may contain the additional information or additional requirements. Content of national part shall not contradict the texts borrowed from the leading pharmacopeias of the world.

13. In case of incorporation own texts join in the borrowed texts of the leading pharmacopeias of the world. Their content logically follows from the borrowed text, opens, supplements or disaggregates contents of the borrowed text.

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