On October 6th, 2017 the draft Law on amendments to the Law of Ukraine "On Licensing Economic Activities" was registered in the Parliament.
The draft envisages the expansion of the list of types of economic activities subject to licensing. It is proposed to supplement the list with such activities as production, wholesale and retail trade, as well as import of medical products. In addition, the reference to medical products is included in the paragraph on licensing of the activities on manufacture, trade and import of medicines.
The explanatory note to the draft law states that the purpose of amendments is to bring Ukrainian legislation closer to the EU law. However, the EU does not have the practice of licensing production, wholesale and retail trade, as well as import of medical products.
At the same time, in order to unify the approaches to regulating the medical products market in Ukraine and the EU and in order to deregulate business, since July 1st, 2017 the requirement to register medical products has been substituted by the requirement to confirm their compliance with the technical regulations. Technical regulations provide only a register of subjects responsible for the introduction of medical products in circulation. This register indicates the location of the manufacturers or their authorized representatives and a list and description of the relevant medical products.
However, despite the validity of technical regulations, the draft does not contain conditions for taking into account their peculiarities when issuing the corresponding licenses for medical products, but only references to the Law “On Medicines”, which, obviously, should be taken only in the context of medicinal products.
We draw your attention to the fact that today medical products are sold by a wide range of subjects on the market, including selling through supermarkets, shops and refuelling stations. Accordingly, given the complexity of the licensing process and the requirement, for example, to entities to provide special conditions for the transportation or storage of licensed products in special licensed warehouses, it is possible to predict a narrowing of the range of entities that will be engaged in the relevant economic activity.
It should also be recalled that the Coalition Agreement of the Verkhovna Rada Factions of VIII Convocation as of November 21st, 2014 and the Strategy of Sustainable Development "Ukraine-2020" provided deregulation of economic activities aimed at improving the investment attractiveness of Ukraine. To accomplish this objective, among others, a new Law "On Licensing Economic Activities", which provided for the reduction of the number of activities subject to licensing, was adopted (the Law came into force on June 28th, 2015).
Thus, the draft, in case of its adoption, will also contradict the above-stated goal.
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