Pharmacy Licensing: Opening and Regulations
Opening a pharmacy in Georgia is regulated by the Law "On Medicines and Pharmaceutical Activities." There are two types of pharmacies: Group I (authorized to sell psychotropic and controlled drugs) and Group II (general). Group I pharmacies require a license, while Group II needs authorization/permit. In both cases, the facility must meet technical regulations (space, temperature control, equipment) and employ a certified pharmacist. Lawyer assistance is necessary to obtain the license, as well as to comply with reference pricing and avoid fines during subsequent operations.
What Does This Service Cover?
Specialists on Legal.ge offer:
- Obtaining License: Preparing application for Group I pharmacy license.
- Authorization: Managing Group II pharmacy authorization process.
- Standards: Consulting on premises arrangement (GPP standards).
- Psychotropic Drugs: Permit for circulation of controlled substances.
- Pricing: Implementing the reference pricing system.
- Inspection: Preparing for regulatory agency checks.
Common Situations When You Need a Lawyer
A lawyer is needed when:
- Pricing Fine: You were fined for selling above reference price.
- License Revocation: You violated controlled drug accounting rules.
- Space Non-compliance: Inspection found temperature violations.
- Non-prescription Sale: You were fined for selling Group I drugs without prescription.
- New Branch: You are opening a pharmacy chain.
Georgian Legal Framework
Regulated by the Law "On Medicines and Pharmaceutical Activities" and "On Licenses and Permits."
Process: How Collaboration with a Specialist Works
The process includes:
- Audit: Checking premises and documents.
- Application: Submitting papers to the Agency.
- Inspection: Checking the facility.
- Permit: Receiving the license.
- Support: Starting operations.
Why Choose Legal.ge?
Pharmaceutical business is strictly regulated. Legal.ge connects you with lawyers who will help you legally open and manage a pharmacy. Find a specialist on Legal.ge.