Two Ways to Register Medicines in Georgia: Fast Market Access vs Full National Registration

Georgia has built a modern regulatory environment that allows two clear pathways for bringing medicines to patients:

1. Recognition pathway – designed for fast market access when a product already holds approval in accepted reference markets.
2. National registration pathway – a stringent, dossier-based route with deeper administrative and scientific/technical requirements.
   

For manufacturers, this dual system creates flexibility: a faster route where eligible, and a comprehensive route where full review is required.

Recognition: when speed and market access matter

Georgia’s recognition mechanism supports rapid entry for products that already have established approvals under accepted reference authorities and countries such as EU, US, CA, etc.

It is often the best fit when a manufacturer wants to expand footprint efficiently and leverage existing regulatory approvals for quicker commercialization in Georgia.

National registration: when a full, stringent review is required

Georgia’s national pathway reflects a more comprehensive approach—requiring a robust package that covers key areas such as manufacturing compliance, product quality, and stability expectations.

As Georgia’s pharmaceutical market has matured, the regulatory framework has grown more demanding—raising the standard for what it takes to register and commercialize products responsibly.

‍For national registration, a key baseline requirement is demonstrating EU GMP, PIC/S GMP, or FDA current GMP compliance for both the API manufacturing site and the finished product manufacturing site, ensuring the entire supply chain meets stringent quality standards from raw material through final release.

Regulations in Georgia have evolved — and we evolved with them

Over the past decades, Georgia’s regulatory requirements have expanded and professionalized in parallel with the market. Mermisi LLC has grown alongside this development—building the internal expertise, operational discipline, and documentation culture needed to perform consistently under increasingly stringent expectations.

Why manufacturers partner with Mermisi

Manufacturers need more than “a distributor.” They need a partner who can reliably navigate the authorization process and convert approval into predictable sales.

With 30+ years of experience in Georgia and a team focused on regulatory readiness and execution, Mermisi has achieved a 99% marketing authorization success track record across projects supported by complete manufacturer documentation.

If you are evaluating Georgia, we can quickly advise:

• which pathway is most likely to apply (recognition vs national), and
• what a realistic authorization and launch plan looks like for your product.
  

Contact us at bd@mermisi.ge to request our short partner overview and onboarding checklist.

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