The Licensing Map of Pharmaceutical Activity
Pharmaceutical business in Georgia is regulated by the Law on Drugs and Pharmaceutical Activities, and different activities fall under different licensing regimes. The twelfth article of the law governs the manufacture of pharmaceutical products, the sixteenth and seventeenth — wholesale and retail sale and the seller's duties, while sanctions are established by the second and third parts of the twenty-seventh article. Exact knowledge of these norms determines which object may sell which products and what fine threatens a violation.
The Licensing Regime of Manufacture
The manufacture of pharmaceutical products is subject to a licensing regime, and the manufacturing permit is issued by the Agency. The manufacture in Georgia of an unregistered pharmaceutical product is allowed only for its registration, for preclinical and clinical research, and for export. The foundation of quality is the good manufacturing practice standards: Georgia selectively recognises a list of international, regional and national standards established by the Government. The manufacturer of a series is responsible for the product's safety, quality and efficacy.
Retail Objects and Their Competences
Retail sale of pharmaceutical products is carried out by an authorised pharmacy, a pharmacy (specialised trade object), a retail trade object and, in cases established by legislation, pharmaceutical personnel or a natural person — subject of independent medical activity. The authorised pharmacy is subject to licensing control and may sell products of the first, second and third groups and prepare officinal or magistral formulas; in a pharmacy — products of the second and third groups, while in a retail trade object only products of the third group may be sold.
To improve the accessibility of products for the population, pharmaceutical personnel or an independent medical activity subject may sell products (other than specially controlled ones) in rural and settlement-type localities. The start and end of sale are subject to mandatory notification to the Agency. It is prohibited to sell products at markets, from open-type trade objects and non-stationary trade places; to sell first and second group products to minors and without prescription; and to sell at a price higher than the referential price.
The placement requirements for objects are also established by law: a pharmacy (specialised trade object) may exist either as a separate, isolated object with its own entrance, or as an isolated area within a retail trade object. In the latter case the sale of pharmaceutical products is carried out by responsible personnel with medical or pharmaceutical education, who may not simultaneously supervise other products or perform other work. The product is placed, with a special inscription, in a specially designated place, clearly separated from other products and protected from the influence of environmental factors.
The Seller's Duties
The principle of regulating sale is ensuring storage and dispensing conditions and adequate documentation for series accounting. The seller must introduce modern means of storage, protect products from temperature and humidity, and maintain sanitary-hygienic conditions. Second group products are not accessible to consumers without responsible personnel, and expired products are stored separately, in isolation.
The seller bears real responsibility for suspicious products as well: where there is reasonable suspicion that a product lacks admission to the market, is falsified, defective or expired, the seller must suspend its sale and immediately notify the Agency, while the Agency verifies the information and, on an established violation, supervises the product's withdrawal from the distribution network.
Fines for Unlicensed Activity and Breach of Conditions
The law divides sanctions into two levels. Unlicensed activity — pharmaceutical manufacture, export or import of a specially controlled product, an authorised pharmacy or a clinical trial without a permit — entails a fine of 4 000 lari, and on repetition 8 000 lari. A breach of the licensing conditions of those same activities entails a fine of 1 000 lari. This means that holding a permit is not sufficient in itself: breaching the conditions is also punished.
Frequently Asked Questions
Which object sells which group of products?
An authorised pharmacy — the first, second and third groups, and prepares officinal and magistral forms; a pharmacy — the second and third groups; a retail trade object — only the third group.
Is a permit needed for manufacture?
Yes — the manufacture of pharmaceutical products is subject to licensing, and the permit is issued by the Agency; the manufacture of an unregistered product is allowed only for registration, research and export.
What fine threatens unlicensed activity?
4 000 lari, and in case of repetition — 8 000 lari; a breach of licensing conditions entails a fine of 1 000 lari.
What is prohibited in sale?
Selling at markets and from open and non-stationary objects; selling first and second group products to minors and without prescription; selling above the referential price.
How We Help on Legal.ge
Pharmaceutical licensing demands an exact account of the object type, the permitted product groups and the licensing conditions. On Legal.ge we help select the licensing regime, prepare notifications and resolve disputes connected with fines. Contact us — we will align your business with every requirement of the law.