The Groups of Pharmaceutical Products
The legal boundaries of telepharmacy in Georgia are defined by the Law on Medicines and Pharmaceutical Activity, and the starting point is the classification of groups. Under Article 11-2, a pharmaceutical product is divided for the purposes of advertising and retail realization into three groups: the first group comprises a product subject to special control and a medicinal means equated with it; the second group comprises a product whose improper use may cause significant harm to health or life and which is issued on prescription; the third group comprises a product which, according to the instructions, may be taken without a physician’s prescription and is issued without one.
The law prohibits assigning one and the same generic name, form and dose under different trade names to more than one group, while every product not assigned to the third group automatically belongs to the second. For a model of remote services this classification is decisive: the assortment of the service is limited precisely by those groups whose realization is permitted for the given object.
The Objects Permitted to Realize at Retail
Under Article 16, the retail realization of pharmaceutical products is carried out by an authorised pharmacy, a pharmacy — a specialised trade object — and a retail trade object, and in cases determined by legislation by personnel holding pharmaceutical education or an independent medical subject who is a natural person. The distribution by groups is likewise exact: in an authorised pharmacy products of the first, second and third groups and the preparation of officinal or magistral prescriptions are permitted; in a pharmacy — of the second and third groups; in a retail trade object — only of the third group.
In a settlement of village or town type, personnel with pharmaceutical education or an independent medical subject may realize products at retail, except those subject to special control. The prohibitions also matter: realization at a market or fair, from an open-type trade object and from a non-stationary trade place is prohibited; the sale without prescription of products of the first and second groups is prohibited; and their sale to minors is prohibited. If a telepharmacy service implies realization, its model must fit within these boundaries — otherwise it constitutes a breach of the law.
The Requirements for the Realizer and the Remote Format
Article 17 regulates the requirements towards the realizer: the principle of regulation is the ensuring of conditions of storage and issue, and the adequate conduct of the documentation necessary for recording the series. The realizer is obliged to record the series of the product intended for realization, to introduce modern means of storage and to ensure storage in conditions protecting the product from the negative influence of temperature and humidity.
For the remote format this means that an order received through a digital channel does not cancel the physical accounting: the recording of the series, the storage regime and the conditions of issue remain the obligations of the realizer. A legitimate model of telepharmacy is therefore built on the infrastructure of the pharmacy, not on its replacement.
The Fines for Unlawful Pharmaceutical Activity
Article 37-2 regulates the measures of liability. Activity of pharmaceutical production, of the export or import of a product subject to special control, of an authorised pharmacy or of clinical research without a permit entails a fine of 4,000 GEL. The same act committed repeatedly entails a fine of 8,000 GEL. For telepharmacy projects these fines are a direct measure of risk: a service operating without an authorised pharmacy falls precisely within the scope of this norm.
When planning a project, this scale of fines is the basis of a preliminary assessment: 4,000 GEL for a first breach and 8,000 GEL on repetition — this is the price that accompanies the choice of an unsuitable model, and it is for this reason that partnership with an authorised pharmacy is often the only reasonable path.
Frequently Asked Questions
Which groups of products may a pharmacy realize?
In a pharmacy products of the second and third groups are permitted; in a retail trade object — only of the third group.
May products be sold from an open place?
No. Realization at a market or fair, from an open-type trade object and from a non-stationary trade place is prohibited.
What is imposed on the realizer?
The recording of the series, the ensuring of storage conditions and the conduct of the corresponding documentation — the requirements of Article 17.
What fine follows operation without authorisation?
4,000 GEL for a first breach and 8,000 GEL on repetition — under Article 37-2.
How We Help on Legal.ge
On Legal.ge we will assess the compliance of your telepharmacy idea with the classification of groups and objects, prepare a partnership agreement with an authorised pharmacy, plan the procedures of recording and storage of series, and protect your interests in relations with the agency. Contact our team at the design stage of the service.