Pharmaceutical law in Georgia is structured through the catalogue of licensable activities and permits of the law on licenses and permits: activities connected with medicinal products are regulated by special permits, while certain production spheres require an activity license. On this page we draw the map of pharmaceutical regulation: which permits govern the import and export of medicinal products, clinical research, pharmaceutical production, and the authorized pharmacy — and what special rule applies to radiopharmaceuticals.
The list of permits in pharmacy
Four positions of the permit catalogue concern pharmacy: a permit for the import or export of medicinal products subject to special control; a permit for the clinical research of a pharmacological agent; a permit for pharmaceutical production — of medicinal products, except narcotic products; and a permit for an authorized pharmacy. These four positions shape the basic architecture of the pharmaceutical business: who may bring controlled preparations in and out, who conducts clinical research, who produces, and who dispenses through pharmacies.
Clinical research and special control
The permit for clinical research of a pharmacological agent is a sensitive zone: research is experimentation involving humans, and the state controls it with a separate permit. The import or export permit for specially controlled medicinal products covers preparations requiring heightened state supervision — there the importer's and exporter's status depends on the permit, not merely on the customs procedure. Understanding which category your product falls into is the first question of compliance.
Production permit and the pharmacy network
The pharmaceutical production permit governs the industrial cycle of medicinal products — and the law is deliberately precise here: the position reads "pharmaceutical production (of medicinal products, except narcotic products)". The carve-out for narcotic products points to separate regulation: that category is governed by other legislation, and conflating it with ordinary pharmaceutical production is a mistake. The authorized pharmacy permit, in turn, controls the retail link: the final stage of bringing a preparation to the consumer happens precisely here, and the state equips this stage with its own status.
The authorized pharmacy and transitional regulation
The authorized pharmacy permit is the key document of retail pharmacy. The law also contemplates a transitional rule: a pharmacy holding a permit to arrange a group I pharmacy does not need to obtain a repeated permit in the form of an authorized pharmacy permit — upon its application, the issuing body must free of charge substitute the permit form with the corresponding one. This norm protects pharmacies that operated under the old system: their status is carried over to the new regulation without additional administrative burden — only the form changes, not a new application or a new inspection. The transitional regulation thus works in both directions: it preserves the force of permits issued earlier and at the same time sets the date from which the new permit architecture becomes binding, so the calendar of the project is checked against both regimes.
The special rule for radiopharmaceuticals
The medical use of radioactive substances is regulated by a separate rule: a person holding an authorization for nuclear and radiation activity, when importing radiopharmaceuticals for medical purposes, is issued only one permit — the position concerning the import, export, and transit of radioactive material — and it is issued for a term of one year. An importer of radiopharmaceuticals thus does not need a whole package of other permits: a single permit tied to the radiation sphere governs it, with a short, one-year life cycle. This simplification serves diagnostic and therapeutic procedures where time is critical and reduced administrative burden is in the patient's interest.
For the full picture, the catalogue of license types must be seen as well: the law defines as licensable such spheres as nuclear and radiation activity, the production and valuation of infant and child food products, and the production of biological pesticides — spheres that revolve around health alongside the production of medicines. In the medical direction, emergency medical care and closely related specialized activities are licensable. On this map each position is bounded by its own issuing body and conditions — which is why planning a project should begin by identifying the correct license or permit category and only then studying its conditions. Ask three questions: at which stage of the chain do you enter — import/export, research, production, or retail; which permit in the catalogue corresponds to that stage; and does your product belong to a special category, such as a specially controlled preparation or a radiopharmaceutical, requiring its own regime.
Frequently Asked Questions
Which permits exist in the pharmaceutical sphere?
Import/export of specially controlled medicinal products; clinical research of a pharmacological agent; pharmaceutical production (except narcotic products); and the authorized pharmacy permit.
Does a group I pharmacy need a repeated permit?
No — a pharmacy holding a group I arrangement permit does not need a new permit; upon application, the issuer must substitute the permit form free of charge.
How is the import of radiopharmaceuticals regulated?
A person holding an authorization for nuclear and radiation activity, importing radiopharmaceuticals for medical purposes, receives only the radioactive-material import position permit — for a term of one year.
Why does the narcotic-products carve-out matter?
Because the production permit explicitly excludes narcotic products: that category is governed by separate legislation, and treating it as ordinary pharmaceutical production is a regulatory error.
How We Help on Legal.ge
Every stage of a pharmaceutical project — from permit to authorization — rests on a precise legal question. On Legal.ge you can consult a lawyer who will assess the required permits and the transitional deadlines. Submit a request on the site and get qualified assistance.