Work on Errors: The State Administration on Medicinal Products and the State Administration on Drug Control will continue the licensing of commercial activities

Οn the 13th of October this year, the Ministry of Health in Ukraine presented for public discussion the Cabinet of Ministers’ draft legislation named “ Some Issues Concerning The Licensing of Commercial Activity”, the text of which has been published on the Ministry’s official website.

The draft legislation proposes to vest upon the State Administration on Medicinal Products and the State Administration on Drug Control the authority to license commercial activities, which they possessed before the entry into force of the Cabinet of Ministers decree № 609 , dating from 05.08.2015 “ Concerning the recognition of the list of authorities, whose licensing and recognition lost the validity of certain decrees by the Cabinet of Ministers of Ukraine”, before the completion of the transfer of licensing acts to the reorganized State Administration on Medicinal Products and the State Administration on Drug Control.

In particular, according to the draft legislation

• The State Administration on Medicinal Products is obliged to continue the licensing of commercial activities concerning the manufacturing, the wholesale and retail trade and the import of medicinal products (excluding Active Pharmaceutical Ingredients) while

• The State Administration on Drug Control is obliged to license commercial activity concerning plant cultivation included in Table I “ List of drug ingredients, psychotropic substances and precursors , approved by the Cabinet ; development, production, manufacture, storage, transportation, purchase, sale ( supply ), import into / export from Ukraine , use, destruction of narcotic drugs , psychotropic substances and precursors included in said List.

It should be reminded that on the 26th August 2015, on the entry into force of the Cabinet of Ministers’ decree № 609 “Concerning the recognition of the list of authorities, whose licensing and recognition lost the validity of certain decrees by the Cabinet of Ministers of Ukraine” the authority of the State Administration on Medicinal Products and the State Administration on Drugs Control as licensing organs of the above mentioned commercial activities was terminated. Instead, the State Authority on Medicinal Products and Drug Control was determined as the new licensing organ, which up until now has not commenced its’ functioning.

Thus, it was determined that a currently nonexistent state organ, is de facto, administering the licensing of the above mentioned commercial activities.

Precisely with the aim of regulating the situation at hand, namely, the prevention of the termination of the licensing procedures of the abovementioned commercial activities, the adoption of the draft legislation , which “continues” the authority, as licensing organs, of the State Administration on Medicinal Products and the State Administration on Drug Control, which are reorganizing until the completion of the transfer of licensing acts to the State Administration of medicinal products and drug control.