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The document ceased to be valid since  June 15, 2015 according to Item 1 of the Order of the Government of the Republic of Kazakhstan of April 27, 2015 No. 336

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 14, 2012 No. 1606

About approval of Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan

According to subitem 12-1) of article 6 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan.

2. This resolution becomes effective after ten calendar days after the first official publication.

 

Prime Minister of the Republic of Kazakhstan

S. Akhmetov

Approved by the order of the Government of the Republic of Kazakhstan of December 14, 2012 No. 1606

Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan

1. General provisions

1. These rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan determine procedure for evaluating safety and quality of medicines, the products of medical appointment registered in the Republic of Kazakhstan (further - Rules), and extend to subjects of drug circulation, products of medical appointment (further - the subject of the address), state body in the sphere of drug circulation, products of medical appointment and medical equipment (daleegosudarstvenny body), the state expert organization in the sphere of drug circulation, products of medical appointment and medical equipment.

2. Assessment of safety and quality of medicines, the products of medical appointment registered in the Republic of Kazakhstan (further - assessment of safety and quality), belongs to the state monopoly and is performed by 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 of the Republic of Kazakhstan which is the state expert organization in the sphere of drug circulation, products of medical appointment and medical equipment and having the test laboratories accredited in the procedure established by the legislation of the Republic of Kazakhstan and its territorial branches (further - the expert organization).

3. Assessment of safety and quality is performed on purpose:

1) the admission in the address during the importing and production of medicines, products of medical appointment in the Republic of Kazakhstan;

2) confirmations of safety and quality in case of doubt in quality of the medicines, products of medical appointment registered in the Republic of Kazakhstan, including withdrawn by state body and also for detection of counterfeited medicines.

4. Payment of cost of assessment of safety and quality is made by the subject of the address into the account of the expert organization according to the prices established by the Government of the Republic of Kazakhstan.

5. The state control of evaluating safety and quality performs state body.

6. For the purpose of safety and quality in the pharmaceutical market of the produced medicines in the conditions of drugstore, the expert organization performs kontrolnoanalitichesky servicing by quality monitoring procedure, and also providing drugstores with chemical reactants, titrovanny solutions according to the current legislation of the Republic of Kazakhstan.

7. For the purposes of application in these rules the following terms and determinations are used:

1) assessment of safety and quality - determination of compliance of safety and quality of medicines, products of medical appointment to data of the registration file, regulating documents on standardization based on which they were registered in the Republic of Kazakhstan;

2) the regulating document on standardization - the regulating document on quality control and safety of medicines, products of medical appointment (further - the regulating document) establishing complex of quality requirements and safety of medicine, products of medical appointment;

3) the conclusion about safety and quality - the document issued by results of the carried-out assessment of safety and quality of medicines, products of medical appointment and granting the right of presence of medicines, products of medical appointment in the market;

4) the test report - the document certifying compliance/discrepancy of medicine, product of medical appointment to requirements of the regulating document;

5) the warranty obligation - the document issued by the expert organization to the applicant for provision in customs authority for the purpose of registration of customs procedure of issue of medicines, products of medical appointment to safe custody;

6) products - medicines and the products of medical appointment registered in accordance with the established procedure and allowed for medical application in the Republic of Kazakhstan;

7) serial assessment of safety and quality - assessment of safety and quality of medicines, products of medical appointment performed with evaluating conditions of production and control of safety and quality of the declared products;

8) the subject in the sphere of drug circulation, products medical the naznacheniyafizichesky or legal entities performing pharmaceutical activities;

9) the applicant - the legal entity or physical person having the license for pharmaceutical activities according to the legislation of the Republic of Kazakhstan on licensing, the representative office of the pharmaceutical company registered in the Republic of Kazakhstan and providing products for assessment of safety and quality.

2. Procedure for evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan

Procedure of assessment of safety and quality

8. Assessment of safety and quality is performed before production in the address.

9. All medicines imported into the Republic of Kazakhstan and made in the territory of the Republic of Kazakhstan are exposed to assessment of safety and quality.

Assessment of safety and quality of medicines is performed by carrying out:

1) serial assessment of safety and quality of medicines, including the immunobiological medicines made according to requirements of proper production practice (GMP) (RK, the EU, the USA);

2) estimates of safety and quality of each series (batch) of the medicines made not according to requirements of proper production practice (GMP) (PK, the EU, the USA);

3) estimates of safety and quality of each series (batch) of the medicines which did not pass serial assessment of safety and quality according to the subitem 1) of this Item.

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