Soloviov O. Scientific-practical and theoretical justification of system of support measures of pharmaceutical law in the sphere of circulation, promotion of medicines and parapharmaceutical products

Українська версія

Thesis for the degree of Doctor of Science (DSc)

State registration number

0518U000363

Applicant for

Specialization

  • 15.00.01 - Технологія ліків, організація фармацевтичної справи та судова фармація

02-03-2018

Specialized Academic Board

Д 64.605.02

National University of Pharmacy

Essay

Dissertationis aimed at the problems of harmonization, adaptation and implementation of national legislative and regulatory system of pharmaceutical law and practical support according to the requirements and international standards in distribution, promotion of medical agents and parapharmaceutical products at the market of Ukraine. Complex scientific and legal research has detected causes and factors of normative and legislative differences of national pharmaceutical law; there has been proved their non-compliance with standard international practice and the changes and additions to the body of majorlegislative acts of Ukraine have been introduced. It was studied, systematized and implemented 222 key positions to 82 normative legal documents. 94 changes relating to regulatory documents in handling and quality control of medicines according PIC/S requirements, parapharmaceutical products, also their promotion and advertising. The drafts of state documents on certification and licensing of personnel have been developed. Was developed and proposed a new version two draft laws of Ukraine on measures to counter falling into circulation counterfeit medicines.

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