ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 12, 2013 No. 223

About approval of Rules of the organization and implementation of monitoring of the prices of medicines, products of medical appointment, and also their forming within the guaranteed amount of free medical care

According to item 4 of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care, No. approved by the order of the Government of the Republic of Kazakhstan of October 30, 2009 1729, I ORDER:

1. Approve the enclosed Rules of the organization and implementation of monitoring of the prices of medicines, products of medical appointment, and also their forming within the guaranteed amount of free medical care (further - Rules).

2. And to its territorial subdivisions to provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan (further - Committee) implementation of monitoring of the prices of medicines, products of medical appointment which are purchased within the guaranteed amount of free medical care.

3. To provide to subjects of monitoring of the prices of medicines, products of medical appointment provision in Committee of price information according to these rules.

4. To provide to developers, producers, and also their authorized representatives, owners of the registration certificate, medicines, products of medical appointment till December 1, 2013 for registration in the Ministry of Health of the Republic of Kazakhstan price information of producers.

5. To committee (Esimov D. S.):

1) to provide state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) after state registration of this order to provide its placement on Internet resource of the Ministry of Health of the Republic of Kazakhstan.

6. To department of legal service of the Ministry of Health of the Republic of Kazakhstan (Danayeva Zh. Zh.) provide official publication of this order after its state registration in the procedure established by the legislation.

7. To impose control of execution of this order on the Vice-Minister of Health of the Republic of Kazakhstan Bayzhunusov E. A.

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

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of April 12, 2013 No. 223

Rules of the organization and implementation of monitoring of the prices of medicines, products of medical appointment, and also their forming within the guaranteed amount of free medical care

1. General provisions

1. These rules of the organization and implementation of monitoring of the prices of medicines, products of medical appointment, and also their forming within the guaranteed amount of free medical care (further - Rules) determine procedure for the organization and implementation of monitoring of the prices of medicines, products of medical appointment, their forming within the guaranteed amount of free medical care and extend to the subjects performing medical and pharmaceutical activities within the guaranteed amount of free medical care (further - GOBMP).

2. In these rules the following basic concepts are used:

1) selling price (retail price within GOBMP) - the price of the provided medicines, products of medical appointment established by results of purchase of pharmaceutical services within one administrative and territorial unit (area, the city of republican value, the capital);

2) authorized body in the field of health care (further - authorized body) - the state body performing management in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation, products of medical appointment and medical equipment, control of quality of medical services;

3) monitoring of the prices of medicines and products of medical appointment - collection, processing and data analysis at the prices of the medicines, products of medical appointment made and imported into the Republic of Kazakhstan within GOBMP (further - monitoring);

4) state body in the sphere of drug circulation, products of medical appointment and medical equipment - the state body exercising the state control in the sphere of drug circulation, products of medical appointment and medical equipment (further - state body);

5) the state expert organization in the sphere of drug circulation, products of medical appointment and medical equipment (further - the expert organization) - the organization performing production economic activity in the field of health care on safety, efficiency and qualities of medicines, and also scientific research in the field of development of new original medicines, pharmacy, pharmacology;

6) the single distributor - the legal entity performing within the guaranteed amount of free medical care purchase of medicines, products of medical appointment, services in storage and transportation of medicines, products of medical appointment and the conclusion of agreements, long-term agreements, and also the organization of purchase of medical equipment;

7) the import price - the price specified in invoice when importing medicines and products of medical appointment to the Republic of Kazakhstan;

8) subjects of monitoring - the physical persons and legal entities performing medical and pharmaceutical activities;

9) average wholesale price - arithmetic average value of wholesale price of trade names of medicines within one international unlicensed name of medicine (further - MNN) taking into account dosage form, dosage;

10) the price of the producer - the price of leave of the manufacturing organization of medicine and product of medical appointment including all types of production costs, delivery notes and all-administrative expenses;

11) the applicant - the developer, the producer, the owner of the registration certificate, the legal entity having the status of the official manufacturer representative authorized to submit the application, documents and materials for carrying out state registration, re-registration of medicines and products of medical appointment, registration/change of the registered prices;

12) organizers of purchase - the customer or person determined by the customer or the Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care approved by the order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729;

13) the registered price - the price of medicine, product of medical appointment according to the trade name taking into account the price of the producer, the incurred expenses on evaluating safety and quality, logistics, customs duties in cases, stipulated by the legislation, approved by authorized body;

14) wholesale price - the price of medicine, product of medical appointment according to the trade name in case of wholesale;

15) the form commission of authorized body - advisory and consultative and expert body;

16) the international reference price - arithmetic average value of wholesale price of trade names of medicines within one MNN taking into account dosage form, dosage in the countries with similar level of living of the population and common economic space;

Marginal 17) the price for medicine within GOBMP - the price established by authorized body above which the purchase cannot be made;

18) internal reference pricing on medicinal means - price analysis on medicines by wholesale and retail prices of trade names of medicines within one MNN taking into account dosage form, dosage;

19) external reference pricing on medicines - price analysis on medicines by wholesale and retail prices of trade names of medicines within one MNN taking into account dosage form, dosage in the countries with similar level of living of the population and common economic space.

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