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The document ceased to be valid since August 6, 2020 according to Item 1 of the Order of the deputy. The Minister of Health of the Republic of Kazakhstan of May 22, 2019 No. KR DSM-84

ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 12, 2009 No. 701

About approval of Rules of withdrawal of samples of medicines, products of medical appointment and medical equipment for conducting examination

According to Item 6 of article 22 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 withdrawal of samples of medicines, products of medical appointment and medical equipment for conducting examination.

2. To committee on control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan () provide to Baymukanov S.A. state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work of the Ministry of Health of the Republic of Kazakhstan (Bismildin F. B.) provide official publication of this order 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 3, 2007 No. 153 "About approval of Rules of withdrawal of the medicines which are in circulation in the territory of the Republic of Kazakhstan for conducting examination of efficiency, safety, quality" (2007 published in the Collection of acts of the central executive and other state bodies of the Republic of Kazakhstan, March is registered in the Register of state registration of regulatory legal acts No. 4582,).

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

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

 

Minister Zh. Doskaliyev

Approved by the order of the Minister of Health of the Republic of Kazakhstan of November 12, 2009 No. 701

Rules of withdrawal of samples of medicines, products of medical appointment and medical equipment for conducting examination

1. General provisions

1. These rules of withdrawal of samples of medicines, products of medical appointment and medical equipment (further - Rules) are developed for conducting examination for the purpose of implementation of the state quality control of medicines, products of medical appointment and medical equipment.

2. These rules extend to all subjects in the sphere of drug circulation, products of medical appointment and medical equipment in the territory of the Republic of Kazakhstan.

3. Withdrawal of samples of medicines, products of medical appointment and medical equipment perform for the purpose of establishment of efficiency, safety and quality of the made and implementable medicines, products of medical appointment and medical equipment.

2. Bases and procedure for withdrawal of samples of medicines, products of medical appointment and medical equipment

4. The basis for withdrawal of samples of medicines, products of medical appointment and medical equipment are:

1) results of checks, according to which established facts of violation of requirements of regulatory legal acts of the Republic of Kazakhstan in the sphere of drug circulation, products of medical appointment and medical equipment;

2) establishment by results of monitoring of side effects of medicines of the facts of manifestation of features of interaction of medicine with other medicines and the side effects including which are not specified in the instruction for use of medicine.

5. Withdrawal of samples of medicines, products of medical appointment and medical equipment at subjects in the sphere of drug circulation, products of medical appointment and medical equipment (further - the subject) is performed by officials of state body in the sphere of drug circulation, products of medical appointment and medical equipment (daleegosudarstvenny body).

6. Samples of medicines, products of medical appointment are withdrawn in the quantities sufficient and not exceeding necessary amounts for conducting examination without compensation of cost of these products. Medical equipment is withdrawn on returnable basis.

7. Withdrawal of samples of medicines, products of medical appointment and medical equipment is drawn up by the act in form, according to appendix to these rules.

8. The subject from which samples medicinal are withdrawn of means, products of medical appointment and medical equipment, stops realization (production) of this series of medicines, products of medical appointment and medical equipment, notifies consumers and informs on the taken measures state body within 10 calendar days from the date of withdrawal.

9. Medicines, products of medical appointment and medical equipment which samples are withdrawn for conducting examination are stored separately with indication of "Is withdrawn before receipt of results of examination, is not subject to realization".

10. The withdrawn samples of medicines, products of medical appointment and medical equipment go to the state expert organization in the sphere of drug circulation, products of medical appointment and medical equipment (daleeekspertny body) which carries out assessment of safety, of efficiency and quality of medicines, products of medical appointment and medical equipment and provides in state body the conclusion within 30 calendar days from the date of provision of samples of medicines, products of medical appointment and medical equipment.

11. In case of the conclusion of expert body about compliance of medicines, products of medical appointment and medical equipment to the established requirements of the legislation of the Republic of Kazakhstan in the sphere of drug circulation, products of medical appointment and medical equipment the state body makes the decision on further realization of medicines, products of medical appointment and medical equipment and informs subject on which the decision on withdrawal, within 5 calendar days from the date of receipt of the conclusion about results of assessment was made.

12. In case of the conclusion of expert body about discrepancy of medicines, products of medical appointment and medical equipment to the established requirements of the legislation of the Republic of Kazakhstan in the sphere of drug circulation, products of medical appointment and medical equipment, the state body makes the decision on prohibition of application and realization of medicines, products of medical appointment and medical equipment, and also on their further destruction and within 3 calendar days informs on it the subject on whom the decision on withdrawal was made.

Appendix

to Rules of withdrawal of samples of medicines, products of medical appointment and medical equipment for conducting examination

Form

Act of withdrawal of samples of medicines, products of medical appointment and medical equipment

 
     Место_________________________ Дата____________________________

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