Export control of goods and technologies used by a pharmaceutical enterprise
Journal Title: Економіка. Фінанси. Право - Year 2019, Vol 7, Issue
Abstract
The article explores the concept of export control, its main forms, means and types. The purpose of the article is to determine the peculiarities of export control of goods and technologies by pharmaceutical companies of Ukraine. At a pharmaceutical enterprise, ensuring export control involves the establishment of departments of internal company control run as export supply departments and carrying out of routine and unscheduled inspections of the conditions of production of pharmaceutical products by executive authorities. The legal conditions for export control are specified at the state and enterprise levels in the form of orders, instructions and procedures for carrying out export control procedures. In a narrow sense, at a pharmaceutical company export control involves having the regulatory, technical documentation for the production of pharmaceutical products verified to comply with international standards and GMP, licensing, certification and to obtain authorizations for the activity and production. In the broad sense, export control supposes the establishment of a product quality management system and authority inspection before production begins, including the stages of raw material quality control, documentation, protocols, packaging, marking, finished products, audit and validation. State export control takes the form of licensing of activities of exporters producing pharmaceutical products, certification of products, planned and unscheduled inspections by the executive authorities of the conditions of production, quality control of medicinal products, issuance of permits for export of goods (one-off, general, open). The export control of pharmaceutical products is a set of organizational, legal and technical and material conditions and measures to ensure the quality management of medicinal products by entities, regardless of the form of business activity. The internal and external types of export control are aimed at ensuring reduction of the number of non-observances in the conditions of production of pharmaceutical products and meet the strategic goal, which is to ensure the international competitiveness of Ukrainian pharmaceutical products.
Authors and Affiliations
Yuliia Mykhailivna Zhelizko
Keywords
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