Introducing a pharmaceutical product into the Georgian market is a strategic process governed by strict legal and regulatory standards designed to protect public health. Success hinges on a precise understanding of the Law of Georgia on Drugs and Pharmaceutical Activity. Our firm provides end-to-end legal support for pharmaceutical companies, managing the complex journey from product registration to post-market compliance. We ensure your market entry is not only successful but also built on a foundation of absolute legal conformity, safeguarding your investment and reputation.
All pharmaceutical products require marketing authorization from the LEPL State Regulation Agency for Medical and Pharmaceutical Activities before they can be distributed in Georgia. The law provides two distinct pathways for this: the national registration procedure, which involves a full dossier review, and a highly efficient recognition procedure. This recognition pathway is available for products that have already been approved by regulatory authorities in ICH member countries (such as the EMA in Europe or the FDA in the USA), significantly streamlining the approval timeline. We provide a thorough initial assessment to determine the most advantageous route for your product and manage the entire submission strategy.
The successful compilation of the registration dossier is a critical and detail-intensive task. It requires extensive administrative and scientific documentation, including Good Manufacturing Practice (GMP) certificates, a Certificate of a Pharmaceutical Product (CPP), and detailed clinical data. Crucially, administrative documents and a Power of Attorney appointing a local legal representative must be provided in Georgian. Our team meticulously manages the entire dossier preparation process, overseeing certified translations and ensuring that every component of your submission meets the agency's exact specifications to prevent costly delays or rejections.
One of the most critical final steps for market access is compliance with Georgia’s mandatory labeling and packaging regulations. The law unequivocally requires that all information on the outer and inner packaging, along with the patient information leaflet, must be provided in the Georgian language. This information must be precise and align with the approved summary of product characteristics. We provide expert legal review of all packaging artwork and text mockups to guarantee full compliance with these stringent requirements, ensuring your product is ready for the Georgian consumer without any regulatory obstacles.
Once your product is on the market, its promotion and advertising are also tightly regulated. The Law of Georgia on Advertising strictly prohibits the public advertisement of prescription-only medicines (Group II) and specially controlled substances (Group I). All advertising materials for over-the-counter (Group III) products require prior review and approval from the regulatory agency. We provide comprehensive legal counsel on your marketing strategies, reviewing all promotional materials to ensure they are compliant, thereby protecting your company from regulatory sanctions and maintaining a strong, reputable presence in the Georgian market.
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