Pharmaceutical Licensing is a mandatory process for any company wishing to manufacture, import, distribute, or sell (pharmacy) pharmaceutical products in Georgia. It is one of the most strictly regulated businesses due to its direct impact on human health. Licensing involves not only document verification but also inspection of premises and equipment. Requirements vary by activity type: manufacturing needs GMP (Good Manufacturing Practice) standards, distribution needs GDP (Good Distribution Practice), and pharmacies need GPP (Good Pharmacy Practice). An error in the application or non-compliance with standards leads to permit denial or suspension of an existing license.
Specialists on Legal.ge offer full legal support for obtaining pharmaceutical activity permits:
- Permit audit: Pre-inspection of your facility (warehouse, factory, pharmacy) for compliance with legal requirements.
- Documentation preparation: Preparing a complete package for the Regulation Agency for Medical and Pharmaceutical Activities.
- Special control permits: Obtaining permits for the turnover of psychotropic and narcotic substances (Groups I and II).
- Pharmaceutical product registration: Managing the state registration process for medicines (national or recognition regime).
- Inspection support: Representation during inspections conducted by the regulator.
In practice, the most difficult part is the technical compliance of the building. For example, a distribution warehouse must have temperature and humidity control systems, zoning, and security systems. A pharmacy needs appropriate space and qualified personnel. It is common for a business to rent and renovate a space, only to find out later that it fails to meet permit conditions (e.g., ceiling height or ventilation). Engaging a lawyer at the planning stage saves time and investment.
In Georgia, this field is regulated by the Law "On Medicines and Pharmaceutical Activities," the Law "On Licenses and Permits," and numerous government resolutions. Since 2022, mandatory GMP/GDP standards have been implemented, significantly tightening requirements. This means older distributors must upgrade their infrastructure.
Working with a specialist guarantees that your application will be flawless. The lawyer coordinates the process with architects, pharmacists, and the agency to ensure permit issuance without delay.
Legal.ge is your guide in the pharmaceutical business. Our experts know every nuance of the regulations and will help you legally start and develop your business.
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