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Health Care

29/ 02/ 2016

Ukraine’s state authorities confirmed their understanding of the necessity to postpone the critical positions of import licensing procedure till 1st of March 2018. This step tends to bring business community some relief for the moment. The relevant information was officially published on the SAUMP’s website.

Medical drugs importers are unable to duly fulfill the new complicated requirements of the import licensing procedure, effective from 1st of March 2016. This situation has elevated tension among the international pharmaceutical manufacturers who could not fulfill these regulatory requirements while acting in a lawful manner. Therefore further supplies of medical drugs from abroad were in doubt.

The status of the CMU Draft Resolution which postpones import licensing requirements till 1st of March 2018 was not clear until 25th of February 2016.

On 25 February 2016 the European Business Association published its press-release and called state authorities for very urgent actions.

The same day, 25 February 2016 in the evening the SAUMP web-published officially its explanation of the Draft CMU Resolution status. The SAUMP will take into account the postponement of the abovementioned critical provisions while inspecting the importers.

The European Business Association is thankful to the SAUMP for a prompt response and the important information of highest significance for the pharmaceutical business community willing to continue medical drugs import into Ukraine.

The SAUMP’s information reduces tension on the market but only for the time being in March 2016. The next step that should be included into state authorities’ agenda is the final adoption of the Draft CMU Resolution.

The European Business Association expects that state control bodies will fully understand the need for proactive actions and effective communication with the pharmaceutical business community in order to avoid further negative consequences.

If such state authorities’ approach goes on further, it will greatly contribute to Ukraine’s approximation to the best EU regulatory practices.

Legal background:

The import licensing was made effective by the Law of Ukraine No.5038-VI dated 4 July 2012 “On amending a number of laws of Ukraine as regards the import licensing of medical drugs and the definition of the term “active pharmaceutical ingredient”.

On 20th of February 2013 the MoH Order of Ukraine No.143 adopted the Licensing Terms on Economic Activites with Import of Medical Drugs; a part of provisions was postponed till 1 March 2016 as a result of amendments made by the MoH Order of Ukraine No.960 dated 8 November 2013.

On 12th of February 2016 MoH Ukraine web-published an updated Draft CMU Resolution “On adopting the licensing terms as regards the manufacturing wholesaling and retailing and importing of medical drugs (apart from the active pharmaceutical ingredients) (Draft CMU Resolution) that anticipates the postponement of a number of licensing requirements till 1st March 2018 (see item 3 of the Draft CMU Resolution.

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