Legal Regulation of the Implementation of the EU Legislation in the Field of Medicines Circulation (Правове забезпечення імплементації законодавства ЄС щодо обігу лікарських засобів)
Journal Title: Медичне право - Year 2016, Vol 1, Issue 2
Abstract
The necessity of implementing the EU legislation in the sphere of medicines circulation along was highlighted. There were also researched the legal means for ensuring the implementation of the EU legislation in the field of the circulation of medicines. It was proved, that the purpose of harmonization of Ukrainian legislation acts with EU law regarding to the circulation of medicines is to regulate the legal relations in the field of circulation of medicines, associated with preparation, issuance of trade licenses, manufactures, imports, wholesale and distance trade, quality control of medicines, define the rights and obligations of the participants of these relations, as well as powers of public authorities in this field. The attention was paid to the possibility of appearance in the commercial legislation of such means of state regulation of pharmaceutical activity as obtaining a license for trading of medical drugs. Receiving of a trading license for a particular medicine indicates permission for its realization in all countries that recognize such license. The necessity of a single codified act, as a legislative act of direct action that would establish requirements for the content of an application for trading license for the medical product requirements to record the characteristics of medicines, and others was proved. The maximum deadline for passing a decision on the application for a marketing authorization medicine, the conditions for its issuance, and additional obligations of the marketing authorization holder for the post-authorization safety study and drug efficacy were developed. Additional means of the state regulation of the pharmaceutical activity were analyzed in article. Specific ways of implementing the EU legislation in this sphere were proposed and potential risks of slowing down of the implementation process of the European legislation were assessed.
Authors and Affiliations
Vitalii Pashkov
Keywords
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- EP ID EP429180
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