The Groups of Pharmaceutical Products
The question of pharmacy licensing begins with which products are to be dispensed. Under Article 11-2, pharmaceutical products are divided for the purposes of advertising and retail sale into three groups: the first group comprises products subject to special control and the medicinal means equated to them; the second — products whose improper use may cause significant harm to human health and life and which are dispensed by prescription; the third — products that can, according to the instruction, be taken without a doctor's prescription.
The rules of classification are also defined: a product of the same generic name, form and dose under different trade names may not belong to more than one group; the minister determines the lists for the first and third groups, the third group being defined on the basis of international practice, while every other product admitted to the Georgian market automatically belongs to the second group. Understanding these three groups is the foundation of licensing — they determine which subject dispenses which assortment.
The Subjects of Retail Sale
Under Article 16, the retail sale of pharmaceutical products is carried out by an authorized pharmacy, a pharmacy (a specialized trade object), a retail trade object and, in cases established by legislation, by personnel with pharmaceutical education or an independent medical activity subject that is a natural person. The assortment follows the type of subject — and this relation is two-sided: the choice of type is determined by the planned assortment, and an expansion of the assortment points to a new licensing status. Concretely: an authorized pharmacy is subject to licensing control and may sell products of the first, second and third groups, as well as the preparation of officinal or magistral formulas per prescription; in a pharmacy the second and third groups are allowed; in a retail trade object — only the third.
To improve the accessibility of products for the population, personnel with pharmaceutical education or an independent medical activity subject may, in a settlement of village or daba type, carry out the retail sale of products other than those subject to special control. The start and termination of wholesale and retail sale are subject to mandatory notification to the agency; the form and procedure of the notification are approved by the minister.
Prohibitions and the Obligations of the Distributor
The law also regulates prohibitions: it is forbidden to sell products at a market or bazaar, from an open-type trade object and a non-stationary trading place; to sell first and second group products to minors; to sell these groups without prescription; and also to sell a product at a price higher than its referential price.
Article 17 shapes the daily discipline of the distributor: series accounting, the provision of storage and dispensing conditions, compliance with the sanitary-hygienic and technical conditions of the instruction, and the rules of placement in a retail object — in a specially designated place clearly separated from other products. Expired products are kept isolated, and suspect products are immediately suspended and reported to the agency.
Liability
Article 37-2 governs illegal pharmaceutical activity: carrying out pharmaceutical manufacturing, the export or import of a product subject to special control, the operation of an authorized pharmacy, or a clinical study of a pharmacological means without a permit entails a fine of 4 000 GEL, and upon repetition — 8 000 GEL. A violation of the conditions of the technical regulation, under Article 37-10, is punished by 500 GEL and, upon repetition, by 1 000 GEL.
The difference between these two sanctions is principled: acting without a permit answers for the illegality of the activity itself, while violating conditions answers for quality — the first must simply never happen, the second is managed by daily control.
Frequently Asked Questions
Which pharmacy dispenses first-group products?
Only an authorized pharmacy subject to licensing control; in it the assortment of all three groups is allowed (Article 16).
Is a notification required to start sales?
Yes — the start and termination of wholesale and retail sale are subject to mandatory notification to the agency in the minister's form (Article 16).
What fine applies to acting without a permit?
4 000 GEL, and upon repetition — 8 000 GEL (Article 37-2).
May second-group products be sold without prescription?
No — the sale of both first and second group products without prescription is prohibited (Article 16).
How We Help on Legal.ge
Pharmacy licensing is a chain of decisions: the assortment — by groups; the type of subject — an authorized pharmacy, a pharmacy or a retail object; the discipline of notification — on the start and termination of sales; and daily compliance — at the level of series, conditions and personnel. The soundness of each link of the chain determines whether the model works without sanctions.
The lawyers working on Legal.ge will help you choose the type of subject, plan the relation of the groups to the assortment, prepare the notifications to the agency and verify compliance with the licensing conditions. Contact us for a consultation — the right form from the start spares you both fines and re-registration.