Over the last few years, Georgia’s pharmaceutical regulation has evolved quickly—and decisively—toward one goal: raising quality standards across the entire market. The latest step is a major milestone.
Under changes effective 1 October 2025, Georgia strengthened the GMP documentation framework tied to products authorized (or intended to be authorized) under both national and recognition pathways.
For manufacturers, this has a clear implication:
Georgia is becoming a “high-trust” market—where market access increasingly favors producers with internationally recognized compliance, transparent manufacturing chains, and regulator-ready documentation.
Georgia introduced new obligations and deadlines around GMP documentation for registered products—and linked non-compliance to registration suspension. The government decision setს out that documentation must be provided by 1 October 2025, and where it is not provided, immediate suspension to follow until the deficiency is corrected.
Just as importantly, the framework now explicitly addresses GMP confirmation not only for the “final” manufacturer, but also for certain upstream manufacturing stages (e.g., Active Pharmaceutical Ingredient (API) manufacturer, unpackaged / bulk product manufacturer), reinforcing a supply-chain-wide quality expectation.
Georgia’s GMP framework for medicinal products is built around recognized GMP systems—including (among others) GMP confirmation aligned with:
In practice, this aligns Georgia with the world’s most established inspection and compliance ecosystems—especially for manufacturers supplying regulated markets.
(For context: the EU requires GMP compliance for medicines for the EU market regardless of where they’re manufactured.)
A key market takeaway discussed publicly in Georgia is that the requirement focus is not only on finished dosage form manufacturing—but increasingly extends to the substance / upstream part of the chain as well.
Local reporting has specifically highlighted the market impact of requiring GMP documentation both for the product and the substance used in manufacturing, noting that this type of approach is seen as unusually strict compared to how many markets operationalize GMP evidence across supply chains.
Bottom line for manufacturers: if you already manufacture for (or are inspected to the standards of) stringent authorities, Georgia becomes a cleaner, more predictable market. If not, Georgia is signaling that the “quality threshold” is rising—and staying high.
This isn’t only a regulatory change—it’s a market-shaping event:
If your products are already authorized in stringent markets—or your sites are audited/inspected to globally recognized GMP standards—Georgia’s direction is an advantage.
To move fast, you’ll want:
At Mermisi, we’ve grown in parallel with Georgia’s regulatory maturation—helping manufacturers navigate increasingly stringent requirements while keeping registrations and launch timelines predictable.
We support partners with:
If you’re evaluating Georgia for market expansion and your manufacturing chain meets recognized GMP expectations, we’d be happy to assess fit and build a practical launch plan.
Contact our Business Development team:
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