State medicinal service amends licenses of some pharmaceutical companies over API
The State Service for Medicinal Products of Ukraine has revised supplements to licenses for carrying out economic operations relating to the importation of medicines, to include them in the list of registered active pharmaceutical ingredients (API).
According to a post on the regulator's website, 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.
The regulator recommended that from January 1, 2015, the issue of licenses for imported medicines be included with other operational issues related to the importation of medicines, along with imports of registered ready-made medicines and imports of registered medicines in bulk, as this allows for the importation of API.
The regulator said that there was several draft laws registered in parliament foreseeing the revocation of the licensing of imported AFI.
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.