Pharmacy Licensing involves obtaining the right to open and operate a pharmacy (retailer). In Georgia, pharmacies are divided into two categories: authorized pharmacies (selling only finished drug forms) and compounding pharmacies (where drugs are prepared on-site). In both cases, requirements are strict and include standards for space, equipment, microclimate, and personnel. Adherence to GPP (Good Pharmacy Practice) standards is mandatory. Special control is imposed on the sale of psychotropic and narcotic substances, requiring an additional special permit. Operating a pharmacy without a license is prohibited.
Specialists on Legal.ge offer full services to start a pharmacy business:
- Space Selection and Audit: Checking the building for compliance with statutory standards (area, zoning, entrance).
- Permit Documentation: Preparing the application for a pharmaceutical activity permit (authorized pharmacy).
- Special Control: Obtaining a permit for selling Group I and II (psychotropic) medications.
- Personnel Documentation: Verifying pharmacist certificates and employment contracts.
- Inspection Preparation: Preparing the pharmacy for the regulator's visit (temperature regime, sanitary norms).
In practice, the most common problem is pharmacy area. According to standards, a pharmacy must have a minimum of 30-40 sq.m (depending on type) and designated zones. Also critical is the storage room for narcotic substances, which must be equipped with an alarm system and bars. A lawyer helps the entrepreneur avoid planning mistakes to prevent permit denial.
In Georgia, pharmacy activities are regulated by the Law "On Medicines and Pharmaceutical Activities" and the Law "On Licenses and Permits." Permits are issued by the Regulation Agency for Medical and Pharmaceutical Activities.
Working with a specialist significantly simplifies the process. The lawyer coordinates communication with the Agency and ensures all documents are flawless.
Legal.ge is your partner in the pharmaceutical business. Opening a pharmacy is profitable but complex, and we will help you start it legally.
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