Almaty 2012
Ministry of Health
Republic of Kazakhstan
SALAMATTY
KAZAKHSTAN
G.U. Raimkulova – Head of
Pharmaceutical Activities Administration ,
Medical and Pharmaceutical Activities Committee,
Ministry of Health of the Republic of Kazakhstan
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Managed by the following:
1) state regulation of the pharmaceutical activities;
2) licensing the pharmaceutical activities and narcotic, psychotropic substance and precursor distribution activities in the field of health;
3) state marketing authorization of the medicinal products, health products and medical devices (MPHPMD);
4) safety and quality assessment of the marketed medicinal and health products;
5) state price control of medicinal products, purchased under the scope of the guaranteed free medical care.
( Code of the Republic of Kazakhstan –On National Health and Health System)
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Regulatory base of the provision of narcotic, psychotropic substances and precursors
1.
2.
3.
4.
5.
6.
Code of the Republic of Kazakhstan (RoK) “On National Health and Health care
System”;
Law of the Republic of Kazakhstan as of July 10, 1998, No 279-I
“On narcotic, psychotropic substances and precursors, their trafficking and abuse”; and countermeasures to
Government Resolution of the Republic of Kazakhstan as of November 10, 2000, No
1693 «On adoption of regulations for state regulation of the narcotic, psychotropic substances and precursors distribution in the Republic of Kazakhstan »;
Government Resolution of the Republic of Kazakhstan as of March 30, 2012, No 396
“On adoption of regulations for medicinal use narcotic, psychotropic substances and precursors, subject to control in the Republic of Kazakhstan”;
Government Resolution of the Republic of Kazakhstan as of May 23, 2007, No 413
“On adoption of exclusion out of control regulations for medicinal products with low narcotic, psychotropic substances and precursors content, whereof substances mentioned above could not be extracted by immediate availability, and specified products list’;
Order of the Deputy Minister of Health of the RoK, as of November 4, 2011, No 786
“On approval of the medicinal products and health products list for free public outpatient provision with specialized medical products in selected diseases (conditions) under warranted free medical care capacity “.
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• 1. quota allocation – demand rate for the Republic of Kazakhstan in NPP based on requirement computation. Is approved by Government of the Republic of Kazakhstan and submitted in accordance with international treaties for international quota approval Republic of
Kazakhstan UN INCB);
• 2. distribution – Republican internal market provision with specified remedies and professional activities guarantee for different agencies under allocated quota in accordance with regulations:
- provision standard is to be approved for importing domestic manufacturers and legal bodies.
consumption standard is to be approved for republican administrativeterritorial units indicating standards for individual consumer organizations
(therapeutic, pharmaceutical, veterinarian, academic, and research organization etc.);
•
3. licensing (narcotic, psychotropic substances, precursors distribution activities,
NPP import and export);
• 4. inspections (narcotic, psychotropic substances and precursors distribution order compliance monitoring).
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Formation of demands order for narcotic, psychotropic substances and precursors in the Health system of the Republic of
Kazakhstan
State quota
MIF of the RK
Government of Kazakhstan INCB UN
Health system demand
Republican consumption standard
International quota
MH of the RK
Composite bod
MPAC MH of RoK
Territorial subdivisions
General request
Oblast, Astana, and Almaty health departments,
Bid and demand calculation
Republican medical organizations
Bid and demand calculation
Medical organizations
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Warranted free medical care capacity (WFMCC)
Medicinal products provision
Emergency care, hospital and hospital replacement care
Out-patient care
In accordance with approved medical
Organizations and drug formularies duly coordinated with regulatory authority
(Medicinal product list, compiled for WFMCC rendering considering organization profile, to be formed by medical organization itself)
In accordance with the List of medicinal products and specialized health products for free provision of individual populations with selected diseases (conditions), which is a subject for regulatory authority approval
(approved by the order of the MH of RoK
No 786 as of 4 November 2011)
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International non-proprietary name
No Pharmaceutical form
*
Опиоидные анальгетики
1.
2.
3.
Morphine
Trimeperidine
Tramadol
Fentanyl
Butorphanol solution for injection 1 % solution for injection 1 %, 2 % solution for injection 100 mg/2 ml, 50 mg/mL, 5%; oral solution 100 mg/1 mL; drops
1000 mg/10mL; film-coated tablet 50 mg; retard tablet (film-coated tablet) 100 mg, 150 mg, 200 mg; capsules 50 mg; rectal suppositories solution for injection 0,005 %; transdermal therapeutic system 12,5 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hour; sublingual tablet 100mg, 200mg, 300mg,
400mg, 600mg, 800mg 4.
5.
solution for injection 2 mg/mL
* All registered in the Republic of Kazakhstan pharmaceutical forms are to be released
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Nowadays, around 77 items of various pharmaceutical forms and dosages for following medicinal products are present in the market of the Republic of Kazakhstan:
1. Morphine hydrochloride – 1 PP (solution for injection);
2. Fentanyl – 16 PP (solution for injection, transdermal therapeutic system and sublingual tablet);
3 .
Trimeperidine – 1 PP (solution for injection);
4.
Tramadol – 41 PP (capsule, drops, tablet, sustained release tablet, solution for injection, suppositories);
5. Combined codein-containing drugs – 18 PP (tablet, syrup, capsule);
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Applicant
State marketing authorization procedure for medicinal products in the Republic of Kazakhstan
Pharmaceutical Control
Committee
Information, analysis and marketing center
General Department
Department of Almaty
Pharmaceutical Control
Committee
Archive
Expert services
Marketing Authorization
Expert Advisory Body Expert services
Marketing Authorization
Test Center
Pharmacopoeial Center Pharmacological Center
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 Upon expertise completion the Expert Report on Drug Safety,
Efficacy, and Quality is compiled
 Based on Expert Report the MPAC MH of the RoK makes decision and issue an order on medicinal product state marketing authorization
 All data on registered MP within 24 hours are entered in the
State MP Registry
An applicant is to be granted by:
 Marketing Authorization
 Approved Company Core Data Sheet
 Medicinal Product Quality Regulatory document (AND)
 Package design
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Out-patient level
PHYSICIAN
In-patient level
Prescription
(А6 format blank sheet with code, number, protection level, and to be certified by a seal of the doctor,
Medical Director’s or Deputy’s signature and Medical
Organization seal).
Valid for 7 consecutive days
Medication administration record of the Medical History is certified by Head of
Department and/or
Organization Manager
Patient
Pharmacy
Is provided by the list of doctors eligible to prescribe opioids
Use (taking) of opioids is performed strictly under the supervision of medical staff at the moment of drug delivery: oral taking, transdermal therapeutic system application (plaster, patch, etc.)
– in the presence of the nurse, injection – in the presence of the physician
Patient
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1. The persons, authorized to work with the opioids, shall prior get the conclusions from psychiatrist and narcologist regarding the
Лица, допущенные к работе с опиоидными organization Manager annually.
анальгетиками должны иметь заключения
2.
3.
4.
алкоголизмом, а также о пригодности к
5.
6.
7.
8.
9.
10.
проведению соответствующей проверки.
Documents on the opioid income side and consumption are to be kept for five years.
On the inside of the door of the lock box, cupboard the check-list of kept medicinal products containing narcotic, psychotropic substances and precursors indicating highest single and daily doses.
Medicinal products, containing narcotic, psychotropic substances and precursors are to be delivered form the storage facility only by the responsible person.
In the assistant room stock of narcotic, psychotropic substances from the Table II of the List should not exceed five-day demand, in departments (offices) of health organizations – three-day demand, in pharmacy storage facilities — thirty-day demand, apart from holidays and weekends.
Unused special prescriptions given by dead patients relatives are to be kept with following destruction. Prescription destruction is to be performed as far as prescription accumulation, but not less than monthly, by incineration of the ongoing committee, included internal affairs body representative. Unused special prescriptions destruction fact is to be registered in relevant act.
To destroy the expired opioids, provided by the deceased patients’ family, breakage, rejects, empty ampules and plasters (transdermal therapeutic systems) as well, and ampules and plasters (transdermal therapeutic systems) with partially used content, under the order of the Health Organization Manager, a constantly functioning committee is to be developed including internal affairs body and sanitary-epidemiological services representatives.
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Ministry of Health
Republic of Kazakhstan
SALAMATTY
KAZAKHSTAN
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