On May 31, the Verkhovna Rada of Ukraine adopted as a basis and as a whole the draft law “On Amendments to Article 9 of the Law of Ukraine “On Medicinal Products” Regarding Simplification of State Registration of Medicinal Products” (reg. No. 4484), which was adopted by the Government on May 25, 2016.

The law provides for the simplification of state registration in Ukraine of drugs registered by the competent authorities of countries with a strict regulatory system (USA, Switzerland, Japan, Australia, Canada). The simplified scheme also applies to medicines registered by the European Medicines Agency (EMA) under a centralized procedure. It is also planned to shorten the deadline for the Ministry of Health of Ukraine to make a decision on the state registration of all medicinal products to 10 working days (instead of a monthly deadline).

The text of the Law will be published in the near future.