A regular meeting of the working group drafting the new law "On Medicinal Products", during which a new version of the draft law was presented by the Partner with Legal Alliance Company Dmytro Aleshko, entrusted with the legal support of the preparation of the document, was held this year on August 21.
According to Dmytro Aleshko suggestions from the members of the working group were partly taken into account in the currently proposed version of the draft. Mr.Aleshko also informed that the draft law on medicinal products is planned to be sent to Ukrainian Representative of the WHO Regional Office for Europe in order to establish its compliance with EU requirements under the initiative of Andrew Shipka, People's Deputy of Ukraine, who chairs the working group. According to the speaker, the WHO Regional Office for Europe reacted positively to this initiative and is ready to provide experts. So, after the final adjustment of the draft law, prepared by the working Group, considering the proposals of the participants of the discussion, the text of the document will be translated into English and submitted to European experts.
Regarding the structure of the draft law Dmytro Aleshko contended that it is now more close to the structure of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use than previous version of the document, which were prepared by the working group. For example, the terminology in the field of good practices is not included into the document, as these issues should be regulated at the level of by-laws. That is, in the case of adoption of the law authorities should approve a number of by-laws and amend regulations existing as of today.
However, according to Mr. Aleshko, today a draft law contains separate sections and notions that are not mentioned in the noted Directive. In the near future, the working group will continue to work on improving the draft document. It is planned to fulfill the work until mid-September, after which the draft law will be released for public review.
Based on materials from Apteka.ua
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