The population of Georgia is about 4 million people. Characteristic features of the medical products market are a low share of national manufacturers and a high dependence on imports. The local manufacturers cover a requirement on medicinal products by 15%.
Georgia holds one of the highest positions in the World Bank’s DoingBusiness Rating for creating favorable conditions for doing business in the pharmaceutical market. Favorable and attractive conditions have been created in Georgia for the importation and circulation of medicinal products: a simplified access regime for medicinal products approved by countries with high regulatory requirements has been introduced; VAT is not charged; import licensing has been canceled; parallel imports are allowed.
Medicinal products are registered either by recognition (fast-track procedure) or by expert evaluation (full procedure).
There is no registration of medical devices in Georgia (with the exception of dental materials, test systems, reagents and allergens), and for import and putting into circulation it is necessary to receive a letter from the Ministry of Health.
The situation is similar for special food products and cosmetics: these products are not required to be registered, but before to import we recommend receiving a letter from the Ministry of Health regarding the classification of the product and the absence of registration requirements.
Competent authorities:
Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia
The central executive body in healthcare
Web site: https://www.moh.gov.ge/
State Regulation Agency for Medical Activities
The competent authority for the expert evaluation of registration materials
Web site: http://www.rama.moh.gov.ge/
The main legislative acts:
- The Law of Georgia “On Medicinal Products and Pharmaceutical Activities”.
- Decree of the Government of Georgia No. 350 “Requirements for the Labeling of Pharmaceutical Products Admitted to the Georgian Market in the National State Registration Regime”.
- Decree of the Government of Georgia No. 331 “On Approval of the List of OTC Medicinal Products”.
Cratia provides professional services of state registration of medical (healthcare) products in Georgia. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:
- registration of medicinal products in Georgia;
- creation and maintenance of a pharmacovigilance system in Georgia;
- certification of medical devices in Georgia;
- certification of special food products in Georgia;
- certification of cosmetics in Georgia.
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.