Aspects of voluntary registration of a pharmaceutical product in Georgia
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Keywords

voluntary registration
pharmaceutical

How to Cite

Dugashvili N., Kvizhinadze N., Nemsitsveridze N., Zarkua T., & Tatalashvili N. (2021). Aspects of voluntary registration of a pharmaceutical product in Georgia . Collection of Scientific Works of Tbilisi State Medical University, 53, 38–42. Retrieved from https://journals.4science.ge/index.php/CSW/article/view/430

Abstract

Registration is a pre-marketing control mechanism that ensures safe, quality and effective pharmaceutical products to be allowed on the pharmaceutical market. The voluntary registration of pharmaceutical products remains a current issue in Georgia, which in turn is one of the most important determinants in polypharmacy (over-prescribed medications). Experts say that the Georgian pharmaceutical market is saturated with many voluntarily registered food supplements and homeopathic medicines. Compared with the foreign registration rules, experts' assessments and the analysis of the economic factor acting on the voluntary registration in Georgia revealed the negative fiscal factor, which indicates the appropriateness of taking certain legislative measures considering the international practice.

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References

საქართველოს კანონი “წამლისა და ფარმაცევტული საქმიანობის შესახებ”. (10.08.2009. N1586 ამოქმედდა 2009 წლის 15 ოქტომბრიდან).

წამლის და ფარმაცევტული საქმიანობის სახელმწიფო რეგულირების ეფექტიანობის აუდიტი/ სახელმწიფო აუდიტის სამსახური. 2015წ.

Homeopathic medicinal products. Commission report to the European Parliament and the Council on the application of Directives 92/73 and 92/74 | Full Text.

Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review, World Health Organization, 2001 | Full Text.

Regulation (ec) no 726/2004 of the european parliament and of the council of 31 march 2004.

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution.

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