A regular meeting of the working group on development of a new version of the Law of Ukraine "On Medicinal Products" was held on October 8, 2014. It was attended by the partner with Legal Alliance Company Dmytro Aleshko and the associates Natalia Modlenko and Alexander Yanev.
Dmytro Aleshko, who made introductory remarks, introduced to the participants achievements of the legal group with the draft law. In particular, Mr. Aleshko drew attention to the rework of sections of the document relating to production and imports, state registration, labeling, package leaflet and summary of product characteristics, as well as wholesale trade, where the proposals of the State Expert Center and representatives of public associations were taking into account.
The meeting was continued by the speech of the associate with Legal Alliance Company Alexander Yanev, who presented to the members of the working group presentation on the results of the implementation of the provisions of Directive 2001/83/EC in the new version of the Law of Ukraine "On Medicinal Products".
The draft law has expectedly caused a lively discussion among the representatives of the pharmaceutical industry, who attended the meeting. The representative of the company "Morion" Igor Kryachko announced a position on the full implementation of Directive 2001/83/EC. However, the majority of participants of the working group were of the opinion that such an approach can lead to a catastrophic effect on the pharmaceutical market. Among other things, the majority supported the idea of "evolutionary" approach to reform legislation on medicinal products and a partial implementation of the provisions of Directive 2001/83/EC.
By the end of the meeting it was decided to proceed with the work on the new version of the Law of Ukraine "On Medicinal Products" taking into account the wishes expressed by the majority of those present at the meeting.
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