ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 5, 2011 No. 1461

About approval of Rules of prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment

According to article 84 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 prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment.

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

Approved by the order of the Government of the Republic of Kazakhstan of December 5, 2011 No. 1461

Rules of prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment

1. General provisions

1. These rules of prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment (further - Rules) determine procedure for prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment.

2. These rules extend to the physical persons and legal entities performing pharmaceutical activities in the Republic of Kazakhstan (further - subjects).

3. The authorized body in the field of health care (further - authorized body) makes the decision on prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment, in cases:

1) discrepancies of medicines, products of medical appointment and medical equipment to requirements of technical regulations and regulating documents on standardization;

2) identifications of side effects of the medicines hazardous to health of the person which are not specified in the instruction for use of medicine;

3) detection in the course of the application of products of medical appointment or medical equipment of defects of design, the principle of action, production execution influencing safety of their application;

4) violations of the approved production process of medicines, products of the medical appointment and medical equipment influencing quality, safety and efficiency of their application;

5) the available data on harming health of the patient, or the consumer in connection with use of medicines, products of medical appointment and medical equipment;

6) data acquisition about insufficiency of scientific and technical technological level of production and quality control, the medicines providing decrease in level of safety of application, products of medical appointment and medical equipment.

4. The owner of the certificate of state registration and re-registration of medicine, product of medical appointment and medical equipment (further - the registration certificate) independently initiates withdrawal of the registration certificate because of inexpediency of the address of medicine, product of medical appointment and medical equipment in the territory of the Republic of Kazakhstan (unprofitability of production, lack of demand, removal of release from production, production closing, by results of pharmakonadzor), only on condition of complete ensuring withdrawal of medicines, products of medical appointment and medical equipment from the address from the market of the Republic of Kazakhstan.

2. Procedure for prohibition, suspension or retirement of medicines, products of medical appointment and medical equipment

5. In case of control, monitoring in the sphere of drug circulation, products of medical appointment and medical equipment the authorized body from the moment of receipt of information according to Item 3 of these rules within five calendar days makes the decision on suspension of medical application of medicines, products of medical appointment and medical equipment, by suspension of action of the registration certificate.

Within three calendar days informs on the made decision territorial subdivisions of authorized body (further - territorial subdivisions) and subject concerning which the decision for acceptance of adequate measures was made on the medicine suspended in the address, product of medical appointment and medical equipment.

Then, in the cases specified in subitems 1) 2), 3) and 5) of Item 3 of these rules the territorial subdivision within five calendar days performs sampling of products of medicine, product of medical appointment, medical equipment, the selected products within three calendar days go to the state expert organization in the sphere of drug circulation, products of medical appointment and medical equipment (further - the expert organization) for examination implementation (the analysis, testing) and receipts of the conclusion. Examination is performed in time, not exceeding thirty calendar days and the conclusion goes to authorized body.

6. In the cases specified in subitems 4) and 6) of Item 3 of these rules the authorized body for implementation of examination appoints inspection check.

7. Experimental testimony and results of inspection check are drawn up according to appendix 1, 2 and 3 to these rules.

8. Sampling of products for examination (the analysis, testing), expenses on conducting examination (the analysis, testing), and also inspection check are performed according to the Law of the Republic of Kazakhstan of January 6, 2011 "About the state control and supervision in the Republic of Kazakhstan".

9. In case of the positive conclusion of the expert organization, positive results of inspection checks and in case of elimination of violations in the specified terms in case of inspection check - the authorized body within ten calendar days makes the decision on removal of suspension of application, realization or production of medicines, products of medical appointment and medical equipment, by renewal of drug circulation, products of medical appointment and medical equipment.

10. In case of the negative conclusion of the expert organization, negative results of inspection checks of subjects, in case of not elimination of violations, in the specified terms, revealed in case of inspection check, in the case specified in item 4 of these rules - the authorized body within ten calendar days makes the decision on prohibition of application, realization or production and to retirement of medicines, products of medical appointment and medical equipment, by prohibition of action of the registration certificate on medicines, product of medical appointment and medical equipment.

11. The authorized body within five calendar days informs on the made decisions territorial subdivisions.

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