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.