This blog covers the following topics:
- Introduction to Georgia
- Georgia & Pharmacovigilance
- Guidelines for Pharmacovigilance Activities (Georgia)
Table of Contents
Introduction
Many people are familiar with the name Georgia, often associating it with the U.S. state.
But, in this article, we are exploring about the country of Georgia. A beautiful nation nestled between the Caucasus Mountains, bordered by Turkey, Armenia, and Azerbaijan.
This time we explore the pharmacovigilance activities within Georgia and the regulations that governing it.
Pharmacovigilance & Georgia
While there is potential for growth in the pharmacovigilance (PV) market in Georgia, agree there are challenges.
The country currently lacks a fully developed PV network, and finding professionals with expertise in pharmacovigilance can be difficult.
In fact, many professionals are still unclear of PV regulations and activities in Georgia.
Recently, yet a few companies, including ours, have entered the market to specifically focus on pharmacovigilance.
There is a lot of uncertainty and misleading information about pharmacovigilance in Georgia.
Some sources claim that there are no regulations in place for pharmacovigilance. This, however, is not entirely true.
While there are regulations in place, they do have limitations, and Georgia has yet to pass explicit laws regarding pharmacovigilance.
“Georgia, a land where ancient history meets breathtaking landscapes, stands as a crossroads of cultures, nestled between Europe and Asia, offering a unique blend of tradition and progress.”
Responsible Authorities
There are two main departments responsible for pharmacovigilance in Georgia:
- Ministry of Labour, Health and Social Affairs of Georgia (MoLHSA)
- State Regulation Agency of Medical Activities (RAMA): RAMA operates under the MoLHSA.
Ministry of Labour, Health, and Social Affairs (MoLHSA) is formally responsible for the health of the population, overseeing the health system, ensuring the quality of health services, and ensuring equitable access to healthcare throughout the country.
However, since the Soviet era, its responsibilities have been significantly reduced, particularly in direct service provision, purchasing, and regulation.
The State Regulation Agency of Medical Activities (RAMA) is the sole regulatory authority responsible for handling adverse event reports, collecting data, and submitting it to the World Health Organization (WHO).
Pharmacovigilance Regulation in Georgia
Here are some glimpse of key points from the official documentation regarding pharmacovigilance:
Current Pharmacovigilance Obligation:
- Article 261 outlines the monitoring of adverse reactions within Georgia.
- Rules for the formation of information flow from healthcare networks regarding the side effects of medicines have been approved.2
Reporting of Adverse Reactions:
- Information about adverse reactions can be submitted in both paper form with a signature and seal, or electronically.
Role of Attending Physicians:
- The attending physician in healthcare institutions is responsible for collecting information about the side effects of medicines. They must complete the notification form and submit it to the coordinating group or doctor-coordinator within 10 days.
Coordinating Group’s Role:
- The coordinating group or doctor-coordinator submits the collected and analyzed notification form to the Pharmacological Committee of MoLHSA once a month.
Information Submission to WHO:
- Every week, the electronic format of the information is sent to the International Drug Monitoring Centre in Uppsala, World Health Organization (WHO), by MoLHSA.
Electronic Transfer of Data:
- The Pharmacological Committee of MoLHSA will, within two weeks, transfer all received forms into an electronic format, following the standards of the WHO’s International Drug Monitoring Centre.
Challenges
- Language barriers
- Difficulty in finding experienced PV professionals
- Incomplete pharmacovigilance regulations
- Translation issues
What can we do to help you succeed in the Pharmacovigilance Georgia?
Are you looking for the right process unit to handle pharmacovigilance in Georgia, someone with in-depth knowledge of the market and valuable expertise in the field?
Feel free to tell us how you’d need local support. No need to overthink it—simply email us and we’ll be happy to assist.
Key Takeaways
While explicit pharmacovigilance guidelines are not yet available in Georgia, there is enough information in place to manage PV activities effectively.
RAMA (State Regulation Agency of Medical Activities) handles all regulatory activities related to medicines and operates under MoLHSA.
Language: It is important to ensure language-specific support when managing pharmacovigilance projects in Georgia (Georgian~Kartuli (ქართული)).
Several online sources you may come across might not trustworthy regarding the timelines and processes.
Conclusion
The information provided above should offer some clarification, with the correct references cited below. We’ve shared all the available details, and we hope it will help those seeking guidance, especially for those unsure of where to begin.
While we may have missed some references, we encourage you to utilize these resources to start acquiring clients more efficiently in the future.
If you feel we’ve overlooked anything in this chapter, please feel free to comment and point it out. Your feedback is invaluable in helping us improve. Read, share, and comment!
References:
- სსიპ ”საქართველოს საკანონმდებლო მაცნე”. “Law of Georgia on Medicines and Pharmaceutical Activities.” Accessed. https://matsne.gov.ge/en/document/view/29836. ↩︎
- წამლის გვერდითი მოქმედების შესახებ სამკურნალო ქსელიდან ინფორმაციული ნაკადის ფორმირების წესის დამტკიცების შესახებ | სსიპ ”საქართველოს საკანონმდებლო მაცნე” Minister of Labour, Health, and Social Affairs of Georgia: AE monitoring [WWW Document], n.d. URL https://www.matsne.gov.ge/ka/document/view/56230?publication=0 (accessed 2.2.25). ↩︎
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