“System of state registration of drugs in Ukraine”

On-site or on-line training



1) Legal framework for registration of drugs inUkraine

2) Organizational structure of theStateExpertCenterof the Ministry of

Health ofUkraineof the Ministry of Health ofUkraine”

3) Procedure of state registration   inUkraine

4) Questions of registration applications for state registration

5) Examination of materials of registration dossier

6) Structure and completeness of the registration dossier for drugs

7) Registration dossier of materials – methods of quality control , instructions for medical use

8) Identification of drugs – mandatory text, font sizes, Braille, graphic design packages

9) Practice of conducting pre-clinical and clinical trials inUkraine

10) Proof of the equivalence of generics – regulatory requirements, design reporting documentation

11) Statutory insurance issues of patients in clinical trials inUkraine

12) Questions of patent protection for trade marks inUkraine

13) Procedure for making changes to the drugs –  types of changes of necessary documents, amendment procedure

14) Organization of pharmacovigilance inUkraine-  requirements,  reporting.

15) Inspection of manufacturing ( GMP recognition ) for drugs submitted for state registration  inUkraine

16) Review of standard errors of the Applicants for work with The State Expert Center of the Ministry of Health ofUkraine. Comments of the Experts

17) Organization of state control drug quality, imported and located in the Ukrainian pharmaceutical market

18) Suspension, prohibition, and the resumption of drugs in the pharmaceutical market ofUkraine

19) Post-registration surveillance over medicinal products registered inUkrainein collaboration with the State Inspectorate for Quality Control of Medicinal Products


Details – REG@nbscience.com


Related information:

Dr.Eugene Zadorin

Scientific Director

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