Drug Approval and Registration Process in Georgia
Admission of a pharmaceutical product to the Georgian market is a strictly regulated procedure aimed at providing quality and safe medications to the population. Any drug, whether locally produced or imported, must undergo state registration (marketing authorization) at the Regulation Agency for Medical and Pharmaceutical Activities. The registration process differs depending on the country of origin and whether it already has approval from trusted regulators (e.g., FDA, EMA). Properly managing this bureaucratic process is critical for pharmaceutical companies to commercialize their products in a timely manner.
Legal.ge offers legal support in the drug registration process. Our specialists will assist you in preparing the registration dossier, selecting the correct regime, and communicating with the Agency. Our goal is to simplify your path to market access and prevent registration suspension or rejection due to technical flaws.
What Does Drug Approval Service Cover?
The service covers all stages of the registration cycle, from application submission to obtaining authorization:
- Regime Selection: Consultation on which registration regime (National or Recognition) is optimal for a specific product.
- Registration via Recognition Regime: Administering the simplified procedure for medications already registered in the EU, USA, or other high-trust countries (Fast track - 7 working days).
- Registration via National Regime: Preparing and submitting a full dossier (administrative, chemical, pharmaceutical, biological, pharmacological, clinical parts) for medications lacking international recognition.
- Labeling and Packaging: Adapting primary and secondary packaging, as well as the instruction for use (leaflet), to the Georgian language and ensuring compliance with legislation.
- Registration of Variations: Legal support for making changes to existing registrations (e.g., manufacturer address, packaging design).
- Re-registration: Managing the renewal procedure after the expiration of the 5-year term.
Common Situations and Scenarios
The most frequent scenario involves a foreign company wishing to register a drug approved in Europe. In this case, the lawyer uses the "Recognition Regime," significantly saving time and resources. The main challenge here is the apostille certification of documents and the accuracy of Georgian translations, which the lawyer oversees.
A more complex scenario involves registering a locally produced drug or one imported from a country not on the "recognized" list. This requires the National Regime, involving laboratory testing of samples and expertise. The lawyer helps the client respond to expert comments and correct deficiencies.
Georgian Legislation and Legal Framework
The process is regulated by the Law on Medicines and Pharmaceutical Activities. Detailed procedures are defined by Government Decree (No. 188) "On Approval of Rules and Conditions for Registration of Pharmaceutical Products". Legislation clearly divides the procedure into two parts: Recognition Regime (relying on the decision of another trusted regulator) and National Regime (full expertise by the Georgian Agency). Standards for labeling and package leaflets are also crucial.
Process of Receiving Services
The process begins with a product audit. The lawyer checks if the drug has an appropriate GMP certificate and where it is registered. Based on this, the strategy is determined. After preparing documents, the application is submitted electronically or physically. If the Agency identifies a deficiency, the lawyer works promptly to eliminate it within the statutory deadline. The final result is receiving the Registration Certificate, granting the right to sell the product.
Legal.ge specialists help you avoid bureaucratic deadlocks and ensure your product's rapid access to Georgian patients.
Why Choose a Specialist on Legal.ge?
Drug registration requires not only legal but also technical and pharmaceutical knowledge. Legal.ge gives you access to professionals who thoroughly understand the registration dossier structure (CTD format) and Agency requirements. With their help, the registration process becomes predictable and effective.
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