Parliament cancels licensing of API imports
The Ukraine parliament on January 15, 2015 passed at second reading draft law No. 1498 on amendments to some Ukrainian laws regarding the cancelation of licensing active pharmaceutical ingredients (API) imports.
The law cancels the licensing API imports, which was to be introduced from January 1, 2015.
After the law is signed by the president it will take effect from the day following its publication.
As reported, the State Service for Medicinal Products of Ukraine revised supplements to licenses for carrying out economic operations relating to the importation of medicines, to include them in the list of registered API’s. Supplements to licenses belonging to the following companies were replaced: public joint-stock company Borschahivka chemical and pharmaceutical plant (Kyiv), public joint-stock company Kyivmedpreparat, private joint-stock company Lekhim, private joint-stock company Darnitsa pharmaceutical firm, public joint-stock company Farmak and Farmatek distribution company LLC.
According to the State Expert Center of the Health Ministry, as of early 2014 110 Ukrainian producers with licenses to produce ready-made medicines worked in the Ukrainian pharmaceutical market, including 22 of them producing AFI.
As of March 11, 2014, 1,442 AFI’s were registered in Ukraine, only 246 of them (17%) are made by domestic pharmaceutical companies, which corresponds to normal global practice.