1. Introduction, general information
Brief information about legislation, terms of import and sales of the medicinal products, staps required for state registration.

2. New registration of the medicinal product
Description of the registration procedure, dossier structure, state fees and service fees.

3. Renewal of registration of medicine
Particularities, structure of the dossier, terms and fees.

4. Variations (changes) to the registration certificate
Types of changes , terms and fees.

5. Translation and preparation of the parts of registration dossier
Translation of the medical and chemical literature, preparation (localization) of the normative documents (AND, TND), instruction for use and package lea.

6. Structure of the registration dossier
Structure of the “simple” (simplified, old) and CTD formats.

7. Commercial offer

8. Legislation in the registration of medicines
Order № 426 (95) about registration of medicines in Ukraine , other normative acts and decrees.

9. State registry of the medicinal products of Ukraine Registry of all registered pharmaceutical products in Ukraine.