Pharmacy Licensing and Permitting Services in Georgia
Opening a pharmacy in Georgia is a profitable but complex business requiring compliance with strict state criteria. Legislation divides pharmacies into groups (I, II, III), each with different permitting regimes. Opening a Group I pharmacy (authorized to sell psychotropic and narcotic substances) is particularly difficult as it is subject to mandatory licensing and high security standards. Group II and III pharmacies require authorization/notification. Choosing the wrong premises, lacking mandatory inventory, or having a deficit of qualified staff automatically leads to license refusal.
Legal.ge offers turnkey legal services for pharmacy licensing. Our specialists assist you from the initial stage — premises selection, to the final stage — receiving the license. We ensure your facility fully meets Ministry of Health technical regulations, eliminating delays and financial losses.
What Does Pharmacy Licensing Service Cover?
Our service covers all bureaucratic and technical nuances:
- Premises Pre-Audit: Inspecting selected premises for compliance with technical regulations (area size, ceiling height, independent entrance, ventilation).
- License Type Determination: Consulting on which pharmacy type (Group I, II, or III) is optimal for your business model.
- Permit Documentation Prep: Filling out applications and compiling attached documents (cadastral extract, staff diplomas, inventory act).
- Inventory and Equipment List: Consulting on purchasing mandatory inventory (refrigerators, safes, thermometers) according to standards.
- Agency Representation: Submitting documents to the Regulation Agency for Medical and Pharmaceutical Activities and managing communication.
- Inspection Readiness: Preparing the facility for the Agency inspectors' visit to ensure the check passes flawlessly.
Common Situations and Scenarios
A typical mistake is incorrect premises selection. For example, an entrepreneur rents a space sharing an entrance with another commercial entity. Legislation requires an isolated entrance. Due to this single detail, the license is denied, and renovation costs are wasted. A lawyer assesses the object beforehand to avoid this risk.
Another scenario involves staff qualification. To obtain a license, the manager (responsible pharmacist) must meet certain criteria and hold a valid certificate. A lawyer checks staff documentation before submission.
Georgian Legislation and Legal Framework
The licensing process is regulated by the Law on Licenses and Permits and the Law on Medicines and Pharmaceutical Activities. Technical conditions are outlined in the Government Decree "On the Rule and Conditions for Issuing Permits for Pharmaceutical Production and Realization". For Group I pharmacies, additional requirements from the Ministry of Internal Affairs regarding alarm systems apply.
Process of Receiving Services
The process starts with inspecting the facility. A lawyer and architect (if needed) check the blueprint. Then documents are collected, and the application is filed. The issuance period for a Group I pharmacy license is 30 days, and for Group II (permit) — 20 days. A Legal.ge lawyer monitors the review and attends the inspection. After receiving the license, we also assist in sending the activity commencement notification.
Opening a pharmacy is a major investment. Protect your capital with the help of professional lawyers.
Why Choose a Specialist on Legal.ge?
Pharmacy licensing is full of technical details (e.g., humidity regimes, safe wall thickness). On Legal.ge, you will find specialists who have successfully licensed numerous pharmacies and know the Agency's requirements by heart.
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