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LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS. Gennadi Vasilyevich Godovalnikov – Director RUE “Center for Expertise an Researches in Health Care”, candidate of pharmaceutical sciences. CONTROLLING-PERMISSIVE SYSTEM OF DRUGS CIRCULATION. Ministry of Health of Belarus. Decision making.

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legislation implementation experience of belarus
LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

Gennadi Vasilyevich Godovalnikov – Director RUE “Center for Expertise an Researches in Health Care”, candidate of pharmaceutical sciences

controlling permissive system of drugs circulation
CONTROLLING-PERMISSIVE SYSTEM OF DRUGS CIRCULATION

Ministry of Health of Belarus

Decision making

Minister of Health

Deputy Minister of Health

Main Department for Pharmacy and medical equipment

Republican Unitary Enterprise «Center for Expertise and Researches in Healthcare»

Pharmacology Committee of the Ministry of Health

Pharmacopoeia Committee of the Ministry of Health

Development of draft decisions

Commission on medical immune-biological drugs

structure of rue center for expertise and researches in healthcare
STRUCTURE OF RUE «CENTER FOR EXPERTISE AND RESEARCHES IN HEALTHCARE»

Director

Deputy Director on Drugs

Deputy Director on medical equipment

Deputy Director on on hygienic registration

Drugs Department

Department for Licensing and Inspection

Department for medical equipment

Department for hygienic regulations and registration

Head of Department-Pharmacology Committee Secretary

Deputy Head of Department-Pharmacopoeia Committee Secretary

Republican reference and analytical laboratory

Department Employees

Pharmacology and Pharmacopoeia Committees’ experts

slide4

CLINICAL TRIALS IMPLEMENTATION

Total Number 199 (as of 26.09.2002)

slide7

974

1000

900

779

800

700

600

476

500

400

300

217

213

204

200

122

87

100

0

Russia

Belarus

Germany

India

Poland

France

Hungary

Latvia

Total 5271 as of September 26, 2002

REGISTRATION OF DRUGS IN BELARUS

slide8

Baltic countries

3%

Belarus

15%

Foreign

production

50%

CIS

32%

Total5271 as of September 26, 2002

REGISTRATION OF DRUGS IN BELARUS

slide10

DRUGS QUALITY CONTROL

Most often met drugs that were indicated as adulterated:

2000 - Nystatin tablets (7), Noshpatablets (5), Summamedpowder (3), Terzhinan vaginal tablets (8), Trichopol tablets (10)

2001-Biceptol tablets (17), Hystaktablets (5), Nystatin tablets (9), Trichopol tablets (9), Essencialle Н capsules (12), Festal dragee (13), Piprolet tablets (7),

9 months of 2002 года - Essencialle Н capsules (5),Mesim (8), Festal (8), Cyston (1), Trental (5)

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