New drug import licensing requirements for Ukraine passed by Parliament

A new law, introducing licensing on the imports of drugs to Ukraine and responsibility of foreign drug manufacturers and their distributors for the quality of imported drugs, was recently approved by the Ukrainian Parliament.

It amends the Law on Medicines and the Law on Licensing and, apart from defining the term “active pharmaceutical ingredient” (AFI), introduces a completely new approach to import of medicinal products - licensing regime. Currently only the production of drugs, as well as their wholesale and retail trade were subject to licensing in Ukraine with drug imports carried out under the license of the wholesale trade.

According to Alexei Solovyov, head of the Ukrainian State Service for Drugs, each foreign drug producer importing its products into Ukraine will be responsible for the quality, efficacy and safety of their drugs, will have to conduct pharmacovigilance, as well as to carry out administrative and criminal liability for the quality of their products.