ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 5, 2011 No. 1460

About approval of Rules of reference of medicines to prescription or non-prescription dispensing

According to Item 5 of article 69 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 reference of medicines to prescription or non-prescription dispensing.

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. 1460

Rules of reference of medicines to prescription or non-prescription dispensing

1. General provisions

1. These rules of reference of medicines to prescription or non-prescription dispensing (further - Rules) are developed according to Item 5 of article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine procedure for reference of medicines to prescription and non-prescription dispensing.

2. Reference of medicine to prescription or non-prescription dispensing is determined in case of state registration, re-registration and modification of the registration file of medicine.

3. State registration, re-registration and modification of the registration file of medicine is carried out according to the procedure by the established authorized body.

4. Reference of medicines to prescription or non-prescription dispensing in case of state registration, re-registration and modification of the registration file of medicine is performed at stage of specialized pharmacological examination by the state expert organization in the sphere of drug circulation.

5. For establishment of reference of medicine to prescription or non-prescription dispensing when conducting pharmacological examination it is carried out:

1) assessment of pharmacological compatibility of components;

2) scientifically based determination of risk degree of abuse: the high risk of abuse or risk of abuse is absent, or is insignificant; determination of the most admissible content of drugs, psychotropic substances and precursors in medicines;

3) assessment of results of research of toxicity, influence on reproductive function, embriotoksichnost, teratogennost, mutagenicity, carcinogenicity, pharmakodinamika, pharmacokinetics, methods of introduction and dosages of the researched substance;

4) assessment of safety and efficiency of medicine by results of clinical trials on the basis of the analysis of the observed complications, side effects, measures for their elimination, dose of medicine, concentration and their interrelation with safety and efficiency of medicine;

5) check of adequacy of doses according to pharmacokinetic parameters the analysis - recommended doses, the dispensing mode taking into account pharmacokinetic properties;

6) assessment of safety and efficiency of medicine on the basis of the given periodically updated account on safety - the analysis of profile of safety, identification of new side effects, contraindications, change of the status of medicine in other countries, updated data on the measures taken by regulatory body or the producer for safety reasons, changes in information on safety of medicine, nature and the number of the serious side effects and which are earlier not registered;

7) origin source assessment (blood, bodies, tissues of the person and animals) and specific activity for immunobiological medicines;

8) pharmacological action, profile of side effects, risk of overdose, dependence and abuse.

6. By results of pharmacological examination of medicine the conclusion about reference to prescription or non-prescription dispensing is constituted.

7. The conclusion of the expert organization about reference of medicine to prescription or non-prescription dispensing is submitted in state body in the sphere of drug circulation, products of medical appointment and medical equipment for approval of the instruction on medical application with indication of leave conditions.

8. Treat medicines of prescription dispensing:

1) the medicines containing the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan according to the legislation of the Republic of Kazakhstan on drugs, psychotropic substances, precursors and measures of counteraction to their illicit trafficking and abuse of them;

2) the medicines having toxicity, genotoksichnost and carcinogenicity;

3) medicines which purpose and the further use need to be carried out in case of constant control of the doctor;

4) the medicines having as a part of substance action and (or) side effects of which require further studying;

5) medicines, including the diagnostic medicines applied only in the conditions of hospital;

6) medicines for treatment of diseases which diagnosis can be established in the conditions of hospital;

7) the medicines intended for parenteral introduction;

8) the medicines influencing reproductive function.

9. Treat medicines of non-prescription dispensing:

1) the medicines which did not enter Item 8 of these rules;

2) the multicomponent medicines containing in the structure small doses of the drugs, psychotropic substances and precursors which are not subject to control according to the legislation of the Republic of Kazakhstan and which cannot be allocated from medicine with readily available methods in the quantities sufficient for abuse of these substances.

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