Health Care

16/ 12/ 2016

The European Business Association Health Care Committee highlighted the necessity to adopt the Licensing Terms (including those for the import of medicines) over a very protracted time period and is finally glad now to witness the success of its lobbying efforts. On 30 November 2016 the Government of Ukraine adopted the CMU Resolution ‘On Adopting the Licensing Terms of Economic Activities as regards the Manufacturing, Wholesaling, Retailing and Importing of Medical Drugs (apart from the active pharmaceutical ingredients)’ (CMU Resolution and Licensing Terms). According to the CMU Resolution separate items of the Licensing Terms that were not feasible for importers in Ukraine are now finally postponed till 1st of March, 2018, with the text amended. It is generally known that the postponement of certain items was delayed in time. However, the State Administration of Ukraine on Medicinal Products demonstrated its full understanding to the general situation, which was described to its attention by the representatives of the European Business Association, and prevented the possible suspension of medicines’ importation into Ukraine via web-placing the necessary clarification on 25 February 2016. Ukraine’s state authorities are expected to implement the comprehensive legislative amendments as regards the medicines’ quality control and licensing terms for the market operators to remove any duplications of different provisions and functions throughout the relevant legislation until 1st of March, 2018. The European Business Association is thankful to all central executive authorities for the adoption of this important legislation and is waiting for its publication on 23 December 2016, according to the Official Journal of Ukraine. We expect that further on, the state control bodies’ understanding will continue to demonstrate the need for timely, proactive actions and effective communication with the pharmaceutical business community in order to avoid any negative impact. Legal background: Import licensing was introduced 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 Terms ‘Active Pharmaceutical Ingredient’’. On 20th of February 2013 the MoH Order of Ukraine No.143 adopted the Licensing Terms of Economic Activities on the 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 was 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 (refers to the items 10, 11, sub-item 12 of item 16, items 17, 21 – Chapter VI of the Licensing Terms) till 1st March 2018 (item 3 of the Draft CMU Resolution). The Draft CMU Resolution was adopted on 30 November 2016.

On 30 November 2016 the Government of Ukraine adopted the CMU Resolution ‘On Adopting the Licensing Terms of Economic Activities as regards the Manufacturing, Wholesaling, Retailing and Importing of Medical Drugs (apart from the active pharmaceutical ingredients)’ (CMU Resolution and Licensing Terms).

According to the CMU Resolution separate items of the Licensing Terms that were not feasible for importers in Ukraine are now finally postponed till 1st of March, 2018, with the text amended. It is generally known that the postponement of certain items was delayed in time. However, the State Administration of Ukraine on Medicinal Products demonstrated its full understanding to the general situation, which was described to its attention by the representatives of the European Business Association, and prevented the possible suspension of medicines’ importation into Ukraine via web-placing the necessary clarification on 25 February 2016.

Ukraine’s state authorities are expected to implement the comprehensive legislative amendments as regards the medicines’ quality control and licensing terms for the market operators to remove any duplications of different provisions and functions throughout the relevant legislation until 1st of March, 2018.

The European Business Association is thankful to all central executive authorities for the adoption of this important legislation and is waiting for its publication on 23 December 2016, according to the “Official Journal of Ukraine”.

We expect that further on, the state control bodies’ understanding will continue to demonstrate the need for timely, proactive actions and effective communication with the pharmaceutical business community in order to avoid any negative impact.

Legal background:

Import licensing was introduced 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 Terms ‘Active Pharmaceutical Ingredient’’.

On 20th of February 2013 the MoH Order of Ukraine No.143 adopted the Licensing Terms of Economic Activities on the 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 was 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 (refers to the items 10, 11, sub-item 12 of item 16, items 17, 21 – Chapter VI of the Licensing Terms) till 1st March 2018 (item 3 of the Draft CMU Resolution).

The Draft CMU Resolution was adopted on 30 November 2016.

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