Re-registration of medicinal products in Ukraine

According to the legislation, submission of the Application for state re-registration of the finished medicine should take place not earlier than a year and not later than 180 days before the current registration certificate validity is over.
If an application is submitted after the specified period, re-registration is carried out according to the procedure provided for the state registration of the medicinal product.
The examination period for the re-registration dossier 90 working days.

Making changes to MA in Ukraine

Terms for making changes:
Materials review on changes introduced to the medicinal products registration dossier lasts not more than 60 working days after the receipt of the relevant materials in the Center.
This period can be shortened due to the urgency of the issue if the changes relate to the safety of the medicinal product.