According to Georgian legislation, pharmaceutical products can be approved via two modes: National or Recognition.  

Considering your business goals, Inpharmatis experts will assist you in selecting the most appropriate mode and ensure a prompt and professional registration process.   

Curious about key differences between the National and Recognition Modes? Here's a snapshot: 

National Mode: 

• Register products from any country
• Duration: 3 months (+/-2 months)
• Scientific requirements: Complete dossier and possible laboratory examination
• Post-registration options: All regulatory life cycle procedures (renewal, variations, etc.) 

Recognition Mode: 

• Eligible countries: EU, UK, Switzerland, Norway, Iceland, Turkey, USA, Canada, Japan, Israel, South Korea, Australia, New Zealand
• Duration: 7 working days (+/-14 days) 
• Simplified scientific process: Partial dossier and expedited assessment of documents only 
• Post-registration options: Only first import procedure - packaging and labelling changes are available

Whether the National or Recognition mode is more applicable, Inpharmatis team will provide support throughout the entire registration process. 

In Georgia, Inpharmatis has local full-time, highly qualified, experienced, multilingual employees with many years of practical experience and successful projects on regulatory affairs and pharmacovigilance services for international and local pharmaceutical companies. 

Inpharmatis is an international consulting company specializes in providing regulatory affairs, pharmacovigilance and quality services with full coverage of all CIS, EAEU, and EU countries: Uzbekistan, Kazakhstan, Russia, Belarus, Kyrgyzstan, Moldova, Armenia, Georgia, Tajikistan, Turkmenistan, Ukraine, Azerbaijan, Mongolia, Latvia, Lithuania, Estonia and others. 

Need expert support for your product registration? Reach out to us at info@inpharmatis.com.

Article author
Nato Lomtatidze,
Regulatory Affairs Manager
Inpharmatis