Pankevych O. Scientific design of an effective mechanism of regulation and self-regulation of pharmaceutical activity in Ukraine.

The aim of the thesis is to design an effective mechanism for combining state regulation and self-regulation of pharmceutical activity in Ukraine. The analysis of the current state of the legislative and regulatory framework for self-regulation has shown that today there is no comprehensive Law of Ukraine, which would serve as an integral legal basis for the effective functioning of self-regulatory organizations. The thesis has studied the issue of the formation of self-regulation of pharmaceutical activity in Ukraine on the basis of reconstruction of its historiogenesis. The institutional principles of self-regulation of pharmaceutical practice in the international aspect have been studied. The methodical system-conceptual approach to the formation of a strategy for the development of the institute of self-regulation of pharmaceutical activity in Ukraine has been processed. The interaction of civil society institutions with state regulatory bodies and self-regulatory organizations for economic and professional activities in Ukrainian pharmacy from the state of “how it is” to the state of “how to be” has been modeled. It is proposed to introduce a full-fledged pharmaceutical self-regulation in Ukraine, due to the legislative delegation of a number of functions of central executive bodies to self-regulatory pharmaceutical organizations. Its essence is to develop, approve and monitor the implementation of standards and rules of economic activity on parity terms with the central executive authorities, as well as independently develop and establish the standards and rules of pharmaceutical activity and monitor their compliance.