April 10, 2000

Drug registration in Ukraine

Drug registration is processed by the Ministry of Health.

Legislation and regulations:
- Medicines Act: regulates the development, production, quality control and distribution of drugs;
- Decree of Cabinet 569 (1998) "About state registration of drugs"

The registration is currently regulated by Decree of the Minister of Health 246 (1999), which regulates examination of the materials for registration of drugs in the Ministry of Health.

Materials for drug registration:
List of necessary materials for drug registration in Ukraine is established in addition to Decree of Ministry of Health 246 (1999). It depends on category of drugs:
- original drugs;
- drugs, reproduced by licensing technology;
- generic drugs;
- known drugs in new pharmaceutical forms;
- known drugs for new indications;
- drugs for manufacturing in Ukraine from registered in Ukraine packing in bulk;
- new or reproduced active substances and excipients.