drug registration requirements for uzebekistan, krygzystan ,georgia

1. REGISTRATION
REQUIRMENTS FOR CIS
COUNTRIES
SUBMITTED BY,
JAYA PRAKASH V,
218311.

2. UZBEKISTAN
• Uzbekistan: The Ministry of Health of the Republic of
Uzbekistan
I. General Documentation
• Administrative data
• Brief description of the medicinal product (SmPC), labeling
and instructions for use
• Detailed description of pharmacological surveillance and risk
management system
• Reports of independent experts on chemical, pharmaceutical
and biological documentation, pharmaco-toxicological
documentation

3. II. Chemical, pharmaceutical and biological documentation
• Composition
• Method of manufacturing (scheme of technological process,
draft of technological regulations)
• Methods for quality control of final product
• Stability data
• Information on dissolution profile
• Data on bioavailability, bioequivalence

4. III. Pharmacological and toxicological documentation
• Toxicity with single administration and administration of
repeated doses
• Data on teratogenicity, gonadotoxicity and embryotoxicity
• Data on carcinogenicity
• Additional safety information
IV. Clinical documentation
• Results of clinical trials.
• Additional information confirming effectiveness and safety,
quality, clinical effectiveness and safety.

5. GEORGIA
• Georgia: Ministry of Labor, Health and Social Affairs of
Georgia
• Registration requirements:
• Administrative documents
• legalized Power of Attorney from the applicant to the
representative
• legalized copy of instruction for medical use approved in
importing country together with its certified translation to
Georgian

6. • legalized copy of registration certificate issued by the
competent authority of importing country, where medicinal
product is registered
• legalized copy of certificate of a pharmaceutical product (CPP)
or Free Sale Certificate
• proposed mockups in Georgian and/or Russian and/or English
• specification(s) and methods of control of medicinal product
• Samples of medicinal product and standard samples

7. KYRGYZSTAN
• KYRGYZSTAN: ministry of health of the kyrgyz republic
• Registration requirements:
• Application for state registration
• Power of Attorney
• GMP compliance certificate
• Duly certified copy of license for production of medicines
issued by the authorized body
• Name of the medicinal product
• Description of appearance of the medicinal product for
medical use

8. • Physical and chemical properties
• Pharmacodynamics and pharmacokinetics
• Overdose symptoms ,relief measures in case of overdose
• Interaction with other medicinal products
• Information on possible effect of the medicinal product on the
ability to drive and operate machinery
• Shelf life and indication not to use the medicinal product after
its expiry

9. COMPARISON STUDY
Requirements UZBEKISTAN GEORGIA KYRGYZSTA
N
Site
registration
yes Yes yes
Stability Zone Zone I Zone I Zone I
Dossier Format Country specific CTD CTD
Language English & uzbic English &
russian
English &
kyrgyzic

10. THANK YOU