Pharmaceutical Law and Business Regulation in Georgia
Pharmaceutical law is a complex field regulating every stage of a medication's lifecycle: from creation and production to import, distribution, and delivery to the end consumer. In Georgia, the pharmaceutical business is subject to strict state supervision. Legislation regulates not only product quality and safety but also market access conditions, pricing, advertising, and competition. For any company operating in this sector, knowledge of and compliance with legislative amendments is vital.
Legal.ge offers comprehensive legal services in pharmaceutical law. Our platform unites experts who assist local and international companies in successful and legal operations within the Georgian pharmaceutical market. Whether opening a pharmacy, setting up a wholesale warehouse, or marketing a medication, our lawyers ensure the legal soundness of your business.
What Does Pharmaceutical Law Service Cover?
The service covers all key aspects of pharmaceutical business regulation:
- Licensing of Pharmacy and Distribution Activities: Obtaining permits for Group I and II pharmacies, as well as licenses for the circulation of substances under special control.
- Standard Implementation (GDP/GPP): Legal support to meet Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP) standards, which are becoming mandatory in Georgia.
- Pricing Regulations: Consultation on the reference pricing system, margin controls, and compliance with state regulations.
- Advertising and Promotion: Legal review of advertising materials, labeling, and the ethical code of interaction with doctors (especially for prescription medications).
- Import and Logistics: Legal assurance of customs procedures, parallel import, and special transport regimes.
- Contracts and Transactions: Drafting agreements for supply, distribution, franchising, and quality assurance (Quality Agreements).
Common Situations and Scenarios
A typical situation is opening a new pharmaceutical warehouse. The company must meet GDP standards, obtain a permit, and pass an inspection. A lawyer helps the company conduct a preliminary audit and prepare documentation (Standard Operating Procedures - SOPs) to ensure the inspection concludes successfully.
Another scenario concerns parallel import. Georgia allows parallel import, giving importers the right to bring in original drugs cheaply from other markets. However, this process has strict notification and repackaging/labeling rules. A lawyer ensures that the importer does not violate the law or infringe on the manufacturer's intellectual property rights.
Georgian Legislation and Legal Framework
The main legislative act is the Law of Georgia on Medicines and Pharmaceutical Activities. It defines the concept of a pharmaceutical product, market access regimes, and control mechanisms. Also important are the Law on Licenses and Permits and Government decrees on reference pricing and GDP/GMP standards. Regarding advertising, the Law on Advertising applies, prohibiting mass advertising of prescription medications.
Process of Receiving Services
Working with a specialist on Legal.ge begins with identifying business needs. If a client plans market entry, the lawyer prepares a "roadmap" for all necessary licenses and registrations. For existing businesses, the lawyer conducts a compliance audit to identify risks (e.g., pricing violations) and issue recommendations. When interacting with the regulator, the lawyer acts as the client's representative, saving time and reducing bureaucratic barriers.
Through our platform, you receive not just legal advice, but a strategic partner who cares about the sustainability of your pharmaceutical business.
Why Choose a Specialist on Legal.ge?
Pharmaceutical law requires specific knowledge that goes beyond general jurisprudence. Legal.ge gives you access to industry experts who know how the Drug Agency works, what Form 100 is, and how to legally document temperature regime violations. This competence is the guarantee of your business safety.
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