Some aspects of state quality control of medicinal products at regional level
DOI:
https://doi.org/10.24959/uekj.19.28Keywords:
State Customs Service of Ukraine, regulation, Medicines, quality controlAbstract
The aim of this article is the analysis of normative legal acts that characterize changes in the legislation on the quality control of medicines, regulations and orders of the State Medical Service of Ukraine regarding the prohibition of the implementation of medical devices in the last 5 years and the substantiation of the conclusions aimed at further improving the quality assurance medical products (m/p).
Results. It was revealed that of the 41 supplier countries in Ukraine, the predominant number of m/p that were banned from marketing, was found in 9 countries (67.98 %). The largest number of m/p that fell under the ban falls to Ukraine (32.25 %), India (15.98 %) and Germany (15.68 %), the lowest number of such m/p is represented by Belgium (5.03 %) Under the prohibition on the implementation of m/p by the release forms, the most commonly burned m/p in tablet form (43.63 %). Anti-hypertensive agents (18.23 %), antiseptic and disinfectants (15.63 %), as well as hormonal (15.63 %) were the leaders among the m/p for the pharmacological groups that most often fell under the prohibition on implementation.
Conclusions. The analysis of the orders and instructions of the State Service of Ukraine to ban the sale of drugs in 2015-2018 indicates a significant decrease in their number in 2018, which indicates the improvement of the state drug quality control system. The largest number of drugs that were banned were found in Ukraine, India and Germany; predominant drugs in pill and liquid forms; Most often, antihypertensive, antiseptic, disinfecting and hormonal agents were banned. The introduction of a unified system for monitoring drug trafficking by labeling medicines with control identification marks based on 2-D coding will allow you to track the entire supply chain of medicines from the manufacturer to the end user and, accordingly, strengthen control over the quality of medicines, their production and import, which will counteract the ingress to Ukraine counterfeit or counterfeit drugs.
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