TajikistanMaking Opioids Available in Eastern Europe

and Central AsiaMarch 5-6, 2013 Vienna

General InformationS=143,100 sq.km Population: 8000 000 people: Number a birth per year – 250000 alive birth Capital : Dushanbe

TAJIKISTAN’S LEGISLATIVE FRAMEWORK REGULATING LEGAL STATUS AND LIABILITY IN THE AREA OF DRUGS MOVEMENT.

• The following laws were adopted in Tajikistan aiming to implement the undertaken responsibilities that emanate from international anti-drug conventions of the UN and to regulate relations in the area of drug control:

• - “On drugs, psychotropic substances and precursors”

• - “On narcological assistance”• - “On licensing separate types of activities”

What opioid analgesics are currently registered in the country ?

Name Form Date of last registration

Country of origin

Fenthanil injection 28.09.2012 Ukraine

Morphine hydrochloride

injection 31.08.2012 Ukraine

Promedol injection 04.02.2011 Ukraine

Promedol ZH injection 31.08.2012 Ukraine

Lunaldin tablets 23.02.2011 Sweden

Metadon syrup 2011 Italy

The national quota for legal use of drugs --Government decree №381 August 29, 2003

Name Main substance in gram

Codeine 449 920Cocaine 1 280Morphine 3 840Trimeperedine 32 000Fentanyl 38Ethyl morphine 6 400Etorphine 5

The system of drug control

Ministry Of Internal Affairs

Ministry of Health

Drug Control Agency

State Agency on Pharmaceutical

Control

Process of registration1. Submission full set of the requested documents to The

State Service for Supervision of pharmaceutical activity of RT(SSSPA) by the company with all related certificates ( GMP , GPP, and etc)

2. Providing with sample of drugs for clinical testing (the main substance)

3. Review by the respective departments of SSSPA ( standardization compliance)

4. Average period of registration from 4 months till 2 years

5. Payment of registration fees that valid for 5 years: for CIS country – 675 USD, for other countries 2089 USD

Importation, warehousing • First step is getting one time permission on

importation of opioids from State Service for Supervision of pharmaceutical activity of RT(SSSPA) (humanitarian purpose or business fee 120 somoni=24 USD)

• Second step is purchases that centralized and implemented by the Ministry of Health ( center of pharmaceutical purchase) and storage on the licensed warehousing

Distribution• Distribution is through for

those organizations, hospitals, outpatients departments and firms, who have a license for activities for work on narcotic drugs, psychotropic substance and precursors. License is issued by the MoH that valid for 5 years.

Control of licit drug trafficking

• The State Service for Supervision of pharmaceutical activity of RT(SSSPA)

• Drug Control Agency• Ministry of Internal Affairs

Regulatory document on legal use narcotic analgesics

The order of the Ministry of Health RT from 21 December 2005, No.670 and MIA RT from 21 December 2005, No.3 “On approval of procedure for the turnover of psychotropic substances” agreed with the Drug Control Agency (DCA), which approves general rules for receiving, storing and recording of psychotropic substances in health care facilities, storage, accounting and dispensing procedures for psychotropic drugs in pharmacies, medical and prophylactic facilities, pharmacy stores, research institutes and education institutions of the health care system and in control and analytical laboratories.

• To implement the Articles 8, 9, 11, 13, 15 and 16 of the Law of Republic of Tajikistan “On drugs, psychotropic substances and precursors”, to ensure procedures for import, storage, distribution, prescription, dispensing, use, destruction and recording of drugs in pharmaceutical, medical, research institutes and other organizations, regardless of their organizational and legal status, ownership type and subordination, strengthening the work on prevention drug addiction, the following forms and regulatory and legal documents were approved by the joint order of the Ministry of Health, Republic of Tajikistan and the Ministry of Internal Affairs, Republic of Tajikistan under # 202/437 dated 25 July, 2001 “On intensifying the work on prevention drug addiction and ensuring legal movement of drugs”:

Who can write opioid prescriptions• Opioid drugs can

prescribe a medical worker with higher medical education according to the norms for one receipt set out in Annex below ( but not more than three drugs in one receipt and max lengths is 10 days)

Name QuantityAlnagon 20 pillsBuprenorphine 0,2 mg 20 pillsCodeine .0,2 g.Codthermops, Codterpin 20 pillsCocaine hydrochloride 0,1 g..Morphine hydrochloride morphilong 0,1 g..Omnopon 0,1 g..Procidol 0,25 g..Promedol 0,25 g..Fepranon 0,025 50 drageeEstocine 12 pillsEthyl morphine hydrochloride (Dionin) 0,2

Note:• For treatment of incurable cancer patients,

the quantity of drug medicaments written in one prescription can be increased for 2 times against the dose indicated in previous table. In this case, the cancer patient will be registered in the drugstore by the written instruction of head of patient care institution (according to attached form) upon agreement with the owner or managers of drugstore to supply him with drug medicaments.

Costing in market

The cost of one vial of Morphine – 1.25 USD one vial of Promedol – 1.35 USD

Calculation for projected need for morphine in the country

• Requirements calculation made by the following methods:- A standard daily dose-depending on the size of the population (the standard method)- Depending on the number of beds

Drop that flowed into the ocean can rightfully call itself the Ocean

Thank you !!!!!!!