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PHARMACEUTICAL BUSINESS REGULATION IN GEORGIA ACCORDING TO THE EUROPEAN UNION STANDARDS

Authors

Tabatadze Nino, Tsomaia Irma, Churgulia Emma, Chikovani Anton

Rubric:World economy
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Annotation

International regulations are intensively introduced in the pharmaceutical activity of Georgia, which is the tendency of the world pharmaceutical business. The pharmaceutical market of Georgia is growing at a fast pace every year and is a very profitable field.

The European Union's pharmaceutical strategy is the development of the pharmaceutical industry and business operations, also reducing the prices of medicines and their availability is of great importance.

The GMP/GDP standards ensure the high quality of pharmaceutical products in circulation and, at the same time, increase the country's export potential. According to the international standards of the European Union, GMP - Good Manufacturing Practice is a system that outlines the production and quality control of pharmaceutical products under standards. Georgia has recently begun implementing Good Distribution Practice (GDP) in pharmaceutical activities. In Georgia, the transition to the GMP/GDP standard is mandatory for all pharmaceutical enterprises and wholesale distributors.

Keywords

Pharmaceutical affairs
GMP
GLP
European Union
GDP

Authors

Tabatadze Nino, Tsomaia Irma, Churgulia Emma, Chikovani Anton

References:

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human usehttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52013XC1123%2801%29.

Rules and Guidance for Pharmaceutical Distributions 2022 (The MHRA Green Guide),
https://www.pharmaceuticalpress.com/product/rules-and-guidance-for-pharmaceutical-distributions-the-mhra-green-guide-2022/.

European GDP Association (GDPA), https://www.good-distribution-practice-group.org/.

The Rules Governing Medicinal Products in the European Union. GMP for Medicinal Products for Human and Veterinary Use. Brussels, 2014. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en.

 The Rules Governing Medicinal Products in the European Union. Guidelines on GMP specific to Advanced Therapy Medicinal Products. Brussels, 2017. https://health.ec.europa.eu/document/download/ad33d9dd-03f0-4bef-af53-21308ce2187d_en.

PIC/S guideline “Good Practices for Data Management and the Integrity in Regulated GMP/GDP Environments, 2021. https://picscheme.org/docview/4234.

Maridashvili M. Business Development for the Pharmaceutical Industry. Danish Scientific Journal (DSJ) 2017, 4, 21-23.

Good Practice Guide on Validation, European Compliance, Academy 2012. https://www.gmp-compliance.org/gmp-news/eca-good-practice-guide-integrated-qualification-and-validation-final-version.

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