Pharmaceutical Violations Defense in Georgia | Legal.ge

PharmaceuticalViolations

What is the fine for selling psychotropics without a prescription?

The fine ranges from 6,000 to 12,000 GEL. Repeated violations can lead to criminal liability and closure of the pharmacy.

Who is liable: the pharmacist or the owner?

For administrative fines, the legal entity (owner) is liable. For criminal offenses, the immediate dispenser (pharmacist) and the organizer are liable.

Can a revoked license be restored?

Yes, it is possible to appeal the decision to revoke a license in court and restore the right to operate.

What happens if expired drugs are found?

Selling expired drugs leads to fines and product confiscation. In cases of severe consequences, it can lead to criminal prosecution.

Introduction: Legal Regulation of Pharmaceutical Activities
The pharmaceutical market in Georgia is strictly controlled by the state, as the quality and availability of medicines directly affect public health. Pharmaceutical violations, such as "pharmacy drug addiction," selling falsified medicines, or selling drugs without a prescription, lead to both severe administrative sanctions (license revocation) and criminal liability. Pharmacy owners, directors, and pharmacists often face charges related to the illegal circulation of psychotropic substances. Qualified legal defense is essential to prove that the violation was not systemic or criminal in nature and to prevent business closure or imprisonment.

What Does This Service Cover?
Our service covers all types of legal problems in the pharmaceutical field:

Criminal Defense: Representation on charges of illegal sale of psychotropic substances, manufacture/sale of falsified medicines, and unlicensed pharmaceutical activities.
License and Permit Defense: Appealing decisions of the State Regulation Agency for Medical Activities regarding the suspension or revocation of licenses.
Appealing Administrative Fines: Defense against high fines imposed for dispensing medicines without a prescription (e.g., Group I medications).
Audit and Prevention: Organizing internal documentation so that the pharmacy meets regulator requirements and prevents violations.
Employee Defense: Individual defense for pharmacists and doctors when liability is personalized.

Common Situations and Scenarios
Pharmaceutical violations often manifest in the following cases:

"Pharmacy Drug Addiction": A pharmacy systematically sells psychotropic medications without prescriptions, which qualifies as a criminal offense.
Falsified Medicines: Medicines are found that do not contain the active ingredient or are produced clandestinely.
Expired Medicines: Expired medications are found in the retail network, leading to fines and product confiscation.
Illegal Import: Importing medicines into the country bypassing registration or customs (smuggling).

Georgian Legal Framework
The field is regulated by the "Law of Georgia on Medicines and Pharmaceutical Activities". Criminal liability is provided by Articles 197 and 198 of the Criminal Code, and especially by articles in the chapter on drug crimes (if controlled substances are involved). Administrative liability is regulated by the Code of Administrative Offenses (Article 44-5 and others), where fines are quite high (e.g., from 6,000 to 12,000 GEL). The Regulation Agency possesses broad powers to suspend the activities of an authorized pharmacy.

Step-by-Step Process
1. Inspection/Control: The Regulation Agency or police conduct a controlled purchase or planned inspection.
2. Protocol/Investigation: Upon discovering a violation, an administrative protocol is drawn up or criminal prosecution begins.
3. Legal Response: The lawyer appeals the protocol in court or joins the criminal case.
4. Evidence: Video recordings, prescription logs, and documents of medicine origin are examined.
5. Outcome: Cancellation/reduction of the fine, retention of the license, or exemption from criminal liability.

Why Choose a Specialist on Legal.ge?
Pharmaceutical law is a narrow specialization. On Legal.ge, you will find lawyers who understand the specifics of the pharmaceutical business and the nuances of drug regulation. They will help you protect your license and freedom under the state''s strict regulations. Find your advisor on Legal.ge.