Navigating Georgia’s New Drug Import Rules

At COREX, our goal is to help patients and one of the ways in which we do that is through our Named Patient Programme — learn more about NPP’s here.

In Georgia — a country at the cutting edge of clinical research — we’re fully up to speed on new Government regulations recently introduced to make the import aspect of these programmes more controlled and traceable. Here’s the breakdown:

WHO DO THESE RULES AFFECT?

• Patients diagnosed with rare diseases or conditions for which treatment options are unavailable in Georgia.
• Patients who have received investigational drugs through a clinical trial but were unable to access them after the trial had concluded.

It’s essential for these patients to have the opportunity to continue treatment, especially as there’s no mechanism for Post-Trial Access in Georgia.

WHAT DO THE RULES SAY?

The new government regulations state that the drugs for these patients must be registered in a country recognised by the Georgian government. The import must come from the markets of countries specified in the decree. A formalised procedure is now in place to determine the quantity of imported drugs and also a list of the entities who are authorised to carry out these activities.

HOW CAN COREX HELP?

We can offer full support in preparing the necessary documentation to submit to the Ministry of Health and handling all customs procedures. We can also ensure that the drug is delivered to the patient (to their home directly or to a convenient clinic) in full compliance with GDPR and relevant Georgian legislation.

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