ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of January 6, 2021 No. KR DSM-4

About approval of rules of reference of medicines taking into account the active ingredients which are their part to categories of the medicines released without recipe and according to the recipe

According to Item 5 of article 233 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" I ORDER:

1. Approve the enclosed rules of reference of medicines taking into account the active ingredients which are their part to categories of the medicines released without recipe and according to the recipe.

2. Declare invalid:

1) the order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 No. 288 "About approval of Rules of reference of medicines to prescription dispensing" (it is registered in the Register of state registration of regulatory legal acts at No. 11233, it is published on June 5, 2015 in information system of law of Ad_let);

2) the order of the Minister of Health of the Republic of Kazakhstan of April 24, 2019 No. KR DSM-49 "About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 No. 288 "About approval of Rules of reference of medicines to prescription dispensing" (it is registered in the Register of state registration of regulatory legal acts at No. 18585, it is published on April 30, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. 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 January 6, 2021, No. KR DSM-4

Rules of reference of medicines taking into account the active ingredients which are their part to categories of the medicines released without recipe and according to the recipe

1. These rules of reference of medicines taking into account the active ingredients which are their part to categories of the medicines released without recipe and according to the recipe (further – Rules) are developed according to Item 5 of article 233 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further – the Code) and determine procedure for reference of medicines to categories of the medicines released without recipe and according to the recipe.

2. In these rules the following terms and determinations are used:

1) the state expert organization in the field of drug circulation and medical products – the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products (further – the state expert organization);

2) active ingredient – the active pharmaceutical substance which is part of medicine.

3. For reference of medicine to prescription dispensing the state expert organization carries out studying:

1) pharmacological compatibility of components;

2) source of origin and specific activity;

3) methods of application and profile of side effects;

4) pharmacological properties (pharmacokinetics, pharmakodinamika);

5) adequacy of doses according to pharmacokinetic parameters: the analysis of recommended doses, the dosing mode taking into account pharmacokinetic properties and risk of overdose;

6) risk degrees of abuse and dependence (high, insignificant or is absent), and also the most admissible content of drugs, psychotropic substances and precursors in medicines;

7) results of research of toxicity, influence on reproductive function, embriotoxity, teratogenecity, mutagenicity, carcinogenicity;

8) safety and efficiency of medicine on basis:

the analysis of the observed complications, undesirable reactions, measures for their elimination, dose of medicine, concentration and their interrelation with safety and efficiency of medicine by results of clinical trials;

the given periodically updated account on safety - the analysis of profile of safety, identification of new undesirable reactions, 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, to changes in information on safety of medicine, nature and the number of serious undesirable reactions, including earlier not registered undesirable reactions;

9) the expected ratio "advantage risk".

4. 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 intended for parenteral introduction;

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

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

5) the medicines intended for treatment of diseases which diagnosis is established in the conditions of hospital or in the organizations having the necessary diagnostic equipment and use of medicine and the subsequent observation it is performed in out-patient conditions;

6) the medicines containing medicinal substance activity and (or) undesirable reactions of which require further studying:

for the first time the registered medicines with new active ingredient;

medicines with limited experience of application (taking into account post-registration experience of use of medicine in other countries, including application in general population (in the presence of clinical trials);

new dosage, the new mode of dosing, new method of introduction, the new indication to application, new age groupes;

7) the medicines constituting danger to health of the person in case of their application according to the instruction on medical application of medicine without medical observation (toxicity, including reproductive toxicity, genotoxicity, teratogenecity, carcinogenicity, the serious undesirable reactions connected with pharmacological activity of active ingredient of medicine, serious unexpected undesirable reactions, interactions with often used medicines which can cause serious undesirable reactions, masking of the main disease);

8) the medicines constituting danger to health of the person in case of use of medicine the population without observance of requirements of the instruction on medical application of medicine (undesirable reactions in case of long-term use of medicine: tolerance, cumulative effects, syndrome of cancellation or ricochet, dependence development, medicinal interactions).

9) the medicines which are subject to prescription dispensing on kliniko-pharmacological groups according to appendix 1 to these rules.

5. The medicines carried to non-prescription dispensing are characterized:

1) lack of capability to cumulation, broad therapeutic range (therapeutic width of medicine);

2) availability of short elimination half-life (no more than 12 hours), extent of linkng with proteins of plasma less than for 90% or amount of distribution is more than 35 liters, lack of clinically significant interactions with other medicines requiring change of the mode of dosing of this medicine or interacting with it medicines;

3) lack of restrictions for application for children of any age, on condition of availability of dosage form of this medicine in the dosages intended for application for children; in the presence at medicine of restrictions its realization without recipe of the doctor is possible only on condition of accurate specifying of the age range in the instruction on medical application (leaf insert);

4) lack of medical contraindications in case of pregnancy and lactation;

5) the medicines which are subject to non-prescription dispensing on kliniko-pharmacological groups according to appendix 2 to these rules.

6. Medicines of prescription dispensing are transferred to category of non-prescription dispensing on condition of change of the following parameters:

1) dosage or concentration of active ingredient and (or) the indication to use of medicine which contains such active ingredient;

2) way of introduction and composition of medicine;

3) general content (quantity of doses) of medicine in consumer packaging.

7. Change of category of leave of medicine is performed on medicine during action of the registration certificate and the advantage risk of medicine does not exert negative impact on ratio.

8. In case of receipt of the new facts on safety and efficiency of medicine within the pharmakonadzor performed according to procedure, stipulated in Item 3 articles 261 of the Code, the state body in the field of drug circulation and medical products makes the decision on change of category of leave of medicine and makes corresponding changes to the lists provided by Items 5 and 6 of these rules.

Appendix 1

to Rules of reference of medicines taking into account the active ingredients which are their part to categories of the medicines released without recipe and according to the recipe

The medicines which are subject to prescription dispensing on kliniko-pharmacological groups

Анатомо - therapeutic and chemical classification system of medicines	Therapeutic subgroup анатомо - therapeutic and chemical classification system of medicines	International non-proprietary name
1	2	3
And Digestive tract and metabolism
A01 Dental medicines	A01AB11	No
A02 Medicines for treatment of the diseases connected with acidity violation	A02BA02 Ranitidine	Ranitidine
	A02BA03 Famotidine	Famotidine
	A02BB01 Mizoprostol	Mizoprostol
	A02BD05 Omeprazol, amoxicillin and кларитромицин	No
	A02BC of the Protonew pump inhibitors	Ilaprazol
	A02BC02 Pantoprazol	Pantoprazol
	A02BC03 Lansoprazol	Lansoprazol
	A02BC04 Rabeprazol	Rabeprazol
	A02BX Other	Rebamipid
A03 Medicines for treatment of functional gastrointestinal frustration	A03AA Synthetic holinoblokator - ethers with tertiary amino group	No
	A03AA05 Trimebutin	Trimebutin
	A03BA01 Atropine	Atropine
	A03BB01 Butilskopolamin	No

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