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Food and Drug Law

Must food labels be in Georgian?

Yes, all food products sold in Georgia must have labeling in the Georgian language. Imported goods must have a sticker with a Georgian translation of the mandatory information.

How difficult is it to register a medicine in Georgia?

It depends on the origin. Georgia has a simplified "recognition regime" for drugs already approved in the EU/USA, making the process faster compared to drugs from other jurisdictions requiring full national registration.

Can I sell food supplements without registration?

Supplements are generally treated as food and do not require the same registration as medicines, but they must comply with food safety and labeling laws. Claims about curing diseases are prohibited.

What are the penalties for mislabeling?

Fines vary depending on the violation but can range from hundreds to thousands of GEL. Repeated violations can lead to product confiscation or suspension of business activities.

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Food and Drug Law in Georgia is one of the most strictly regulated areas, as it directly impacts public health and safety. This practice covers the legal regulation of the production, import, distribution, and sale of food, pharmaceuticals, biologically active supplements (supplements), and cosmetics. Georgian legislation in this area is gradually approximating European Union standards, requiring businesses to constantly update their practices and meticulously observe complex technical regulations. Errors in labeling, composition, or the registration process can lead to product recalls, substantial fines, and reputational damage.

Lawyers available through our platform assist pharmaceutical companies, importers, manufacturers, and distributors in navigating regulatory mazes. This includes both the drug registration process and compliance with food safety norms and consumer protection laws.

What does Food and Drug Legal Service cover?

Specialists offer services in the following areas:

  • Pharmaceutical Registration: Assistance with state registration of medicines, obtaining market authorization, and compliance with national GMP (Good Manufacturing Practice) standards.
  • Food Labeling and Packaging: Consultation on labeling rules (Georgian language requirements, allergens, nutritional value) to ensure the product complies with technical regulations.
  • Import and Export Regulations: Managing customs and regulatory procedures when moving food supplements, special purpose foods, and medicines across the border.
  • Licensing and Permits: Obtaining necessary permits for opening an authorized pharmacy, pharmaceutical manufacturing, or food distribution.
  • Product Liability: Defense in disputes related to product safety, responding to consumer complaints, and managing mass recalls.
  • Advertising and Marketing: Legal assessment of advertising for medicines and food supplements to ensure compliance with the Law on Advertising.

Common Scenarios and Needs

Legal involvement is essential in scenarios such as:

  • A foreign pharmaceutical company entering the Georgian market needing rapid and smooth registration of medicines with the Ministry of Health.
  • A food manufacturing company being fined for incorrect labeling (e.g., failure to list allergens), requiring an appeal.
  • Importing biologically active supplements when customs demands additional proof that the product is not a medicine.
  • Opening a pharmacy that requires a special permit and inspection of storage conditions for psychotropic medications.
  • A competitor placing misleading advertising that harms your product's reputation.

Georgian Legislation and Regulations

This field is regulated by specific and extensive legislation:

  • Law of Georgia on Medicines and Pharmaceutical Activities: Regulates the circulation, registration, quality control, and pharmaceutical activities of medicines.
  • Code of Food/Feed Safety, Veterinary and Plant Protection: The fundamental law on food safety.
  • Technical Regulation on Food Labeling: Defines in detail what information must be placed on the product.
  • Law of Georgia on Advertising: Imposes restrictions on advertising prescription medicines and attributing medicinal properties to food products.

Service Process

Cooperation with a specialized lawyer involves:

  1. Product Analysis: Legal classification of the product's composition and purpose (food, supplement, or medicine).
  2. Dossier Preparation: Preparing the registration documentation package in accordance with regulator requirements.
  3. Submission and Monitoring: Submitting the application to the relevant agency (Regulation Agency for Medical and Pharmaceutical Activities or NFA) and monitoring the process.
  4. Compliance Audit: Periodic checks of labels, advertising materials, and warehouse conditions.

Find a Specialist on Legal.ge

Regulations in the pharmaceutical and food industries are constantly changing. Legal.ge offers access to lawyers who constantly monitor these changes and have practical experience dealing with the Ministries of Health and Agriculture. Find your partner on Legal.ge to ensure your product is safe, legal, and successful in the market.

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