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ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 29, 2015 No. 421

About approval of Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products

(The last edition from 27-05-2019)

According to Item 2 of article 85 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products.

3. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development 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 after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

4. To impose control of execution of this order on the Vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

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

Minister

T. Duysenova

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015, No. 421

Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products

Chapter 1. General provisions

1. These rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products (further - Rules) determine procedure for carrying out pharmakonadzor and monitoring of safety, quality and efficiency of the medical products registered in the Republic of Kazakhstan.

2. The Pharmakonadzor is performed according to requirements of the Standard of proper practice of the pharmakonadzor approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 27, 2015 No. 392 "About approval proper pharmaceutical the practician" (it is registered in the Register of state registration of regulatory legal acts at No. 11506) (further - the Standard).

3. For the purposes of these rules the following terms and determinations are applied:

1) the absent information - lack of data on safety or about features of use of medicine for certain groups of patients which can be clinically significant;

2) potential risk - undesirable consequence of pharmacotherapy concerning which there are bases for suspicions on availability of interrelation with medicine however this interrelation properly was not confirmed;

3) validirovanny signal - signal for which in the course of accomplishment of validation and assessment of confirmatory data it is determined that the available documentation is sufficient for the assumption of availability of new potential cause and effect relationship or new aspect of the known interrelation between acceptance of the suspected medicine and development of adverse effect and, therefore, need of implementation of complex of further actions according to signal is determined;

4) signal - information arriving from one or several sources which assumes availability of new potential cause and effect relationship or new aspect of the known interrelation between impact of medicine and the undesirable phenomenon or set of the interconnected undesirable phenomena, estimated as sufficient for further actions for verification of signal;

5) state body in the sphere of drug circulation and medical products - the department of authorized body in the field of health care performing regulation in the sphere of drug circulation and medical products;

6) the state expert organization in the sphere of drug circulation and medical products - the republican state company on the right of economic maintaining performing production economic activity in the field of health care on safety, efficiency and qualities of medicines (further - the expert organization);

7) the risks connected using medicine - any risk connected with quality, safety or efficiency of medicine in relation to health of patients or the populations or any risk leading to undesirable impact on the environment;

8) serious deterioration in the state of health - life-threatening disease, permanent defeat of function of organism or irreversible damage of structure of body, the condition requiring medical or surgical intervention for the purpose of prevention of life-threatening disease, either permanent defeat of function of organism, or irreversible damage of structure of body, the condition requiring hospitalization or significant increase in term of stay in hospital of already hospitalized patient, functional violation from fruit, his death, congenital anomaly or patrimonial injury);

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