According to Government Resolution No. 114 “Approval of the stages and other conditions for the submission of a document certifying the production under GMP (Good Manufacturing Practice) standards of a pharmaceutical product approved or intended for entry into the Georgian market in the national and recognition mode” of March 4, 2022, mandatory submission of a GMP certificate is now required during new registrations and renewals. 

According to the Resolution, Georgia recognizes the following GMP standards: 

• EC (European Commission) – recognized as the national standard 
• WHO (World Health Organization) 
• PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme) 
• FDA (Food and Drug Administration) 

Additionally, Georgia recognizes the standards of countries with stringent regulations, such as Japan, Iceland, Turkey, Australia, South Korea, and Israel. 

Marketing authorizations (MA) for pharmaceutical products registered in the national mode, which are not produced in countries under the control of strict regulatory authorities recognized by the Government of Georgia, face registration suspension upon the expiration of the GMP certificate. Such countries include the CIS countries, China and India, as well as all those who are not included in the list of countries for recognition approved by the Georgian Government. The marketing authorization holder (MAH) must submit an updated GMP certificate to the Regulation Agency for Medical and Pharmaceutical Activities. 

Currently, those marketing authorization holders (MAH) who have not submitted valid GMP certificates on time receive letters from the Regulation Agency about the suspension of the MA and the requirement to submit GMP certificates. 

If your company has not timely provided a GMP certificate, Inpharmatis will support you in managing all required activities and processes for successful GMP certification. Inpharmatis has over 15 years of experience in conducting GMP pre-audits and supporting global and local pharmaceutical companies with official GMP inspections in the EU and CIS regions. Inpharmatis also has a local team of experts closely collaborating with Georgia's Regulatory Authorities.  

For more information, please contact us at info@inpharmatis.com.