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Pharmaceutical Law

What is GMP certification?

GMP (Good Manufacturing Practice) certification is mandatory for pharmaceutical manufacturers in Georgia to ensure products are consistently produced and controlled according to quality standards.

Can I import medicines for personal use?

Yes, individuals can import a limited quantity of medicines for personal use (usually up to 10 standard packages) without a special permit, provided they have a prescription.

How to open a pharmacy in Georgia?

You need to register a company, find suitable premises meeting sanitary norms, hire a certified pharmacist, and apply for a permit from the Medical Regulation Agency.

What are reference prices?

Reference prices are price caps set by the government for certain essential medicines. Selling above this price is illegal and results in fines.

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Pharmaceutical Law: Legal Services for Pharma Business

Pharmaceutical Law regulates the production, import, distribution, and sale of medicines in Georgia. This industry is subject to the strictest state control as it is directly linked to public health and safety. Recent reforms (introduction of reference pricing, mandatory GMP/GDP standards) have significantly changed the rules of the game in the market. Pharmaceutical companies, pharmacies, and distributors are obliged to comply with complex regulatory requirements. Any deviation, whether it involves violating quality standards or ignoring pricing rules, leads to heavy financial sanctions and license revocation. Assistance from a lawyer is essential to ensure full compliance with these regulations.

What Does This Service Cover?

Experts in pharmaceutical law on Legal.ge offer comprehensive legal support:

  • Pharmacy Licensing: Obtaining permits required for opening Group I (medicines subject to special control) and Group II pharmacies.
  • Drug Registration: Managing the state registration process for pharmaceutical products (national or recognition regime) and obtaining market access rights.
  • GMP/GDP Standards: Consulting on the implementation and certification of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
  • Import/Export Permits: Obtaining special permits required for the import and export of medicines.
  • Reference Pricing: Consulting on the state-imposed reference pricing system and compliance of pricing policies with the law.
  • Representation: Defending interests at the Agency for Regulation of Medical and Pharmaceutical Activities during disputes or inspections.

Common Situations When You Need a Lawyer

In the pharmaceutical business, lawyer involvement is critical in the following cases:

  • Opening a Pharmacy: You want to open a pharmacy chain or an individual pharmacy and need precise information on space, equipment, and personnel requirements.
  • Psychotropic Drugs: You plan to sell substances subject to special control, requiring a particularly strict permit and security measures.
  • Pricing Fine: The regulator fined you for selling a drug above the reference price, and you want to appeal the decision.
  • Registration Refusal: The Ministry refused to register a new drug due to documentation flaws.
  • Biologically Active Supplements (BAA): You want to import dietary supplements and need to distinguish them from drugs to avoid complex registration procedures.

Georgian Legal Framework

The main law is the Law of Georgia on Medicines and Pharmaceutical Activities. Also important is the law "On Narcotic Drugs, Psychotropic Substances, Precursors and Narcological Assistance." Implementation of GMP and GDP standards is regulated by the Government Decree on "Recognition of International Standards for Pharmaceutical Production." The reference pricing system is defined by orders of the Minister of Health.

Process: How Collaboration with a Specialist Works

Working with a pharmaceutical law specialist involves:

  1. Analysis: Studying the business model (manufacturing, import, or retail) and determining necessary permits.
  2. Dossier Preparation: Preparing the registration dossier for the pharmaceutical product.
  3. Application: Submitting the applicant's request to the regulatory agency.
  4. Inspection: Preparing the facility (warehouse, pharmacy) for preliminary inspection.
  5. Support: Post-licensing legal consultations (e.g., on pricing).

Why Choose Legal.ge?

The pharmaceutical business requires detail-oriented and competent legal support. Legal.ge connects you with lawyers experienced in pharmaceutical regulations and dealing with state agencies. Protect your business from sanctions and ensure legal operation with the help of our experts. Find a specialist on Legal.ge.

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