Currently, the Applicant (Marketing Authorization Holder) has no obligations to establish and maintain a local pharmacovigilance system in Georgia.

Monitoring of adverse effects of medicinal products is carried out in accordance with Article 26 of Law No. 1586 “On Medicinal Products and Pharmaceutical Activity” and is coordinated by the Agency for State Regulation of Medical Activities.

Information about adverse reactions is submitted in paper form with a signature and seal. The deadlines for adverse reaction reporting are as follows:

• unexpected serious reactions – 2 days;
• other types – within a month.

Despite the absence of a mandatory requirement to create and maintain a pharmacovigilance system Cratia offers a range of activities for managing the medicinal product safety in Georgia. We are ready to outsource of a local contact person, monitoring information about adverse events, monitoring literature and websites, periodically reviewing and updating the instructions for use.

 
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.