The import regime for specially controlled substances
The importation across the border of certain categories of substances requires special authorization. In the list of permits of the Georgian Law on Licences and Permits this direction contains two significant blocks: radioactive materials and medicinal products subject to special control. Both blocks, because of the high risk to health and safety, are placed under separate permit control.
Import of radioactive materials
Under the list, the import, export, transit and return to the manufacturer of radioactive material, as well as the import and export of nuclear technologies or know-how, are regulated by one permit; separate positions are the acquisition of radioactive material within the country and the export of radioactive waste. This means that the entire cycle of international circulation is defined for the importer: acquisition within, import-export-transit, return, and the removal of waste — each operation requires its own permit cover. The same permit also covers the import and export of nuclear technologies or know-how — which means that even the transfer of knowledge, and not only of material product, is an object of state control.
Medicinal products subject to special control
A separate category in the list is the permit for the import or export of medicinal products subject to special control. This part of pharmaceutical production is the object of dual control: it is subject both to the regulation of medicinal products and to special control, and therefore its foreign operations are covered by a separate permit. In this connection the list also contains other permits of a pharmaceutical profile: the permit for clinical research of a pharmacological product and the permit for pharmaceutical production.
The special rule for radiopharmaceuticals
Where the two spheres intersect — radioactive material and medicinal product — the law establishes a special rule: where a person holding authorization for nuclear and radiation activity for the medical use of radioactive substances imports radiopharmaceutical products for medical purposes, only the permit for the international circulation of radioactive material is issued, for a term of 1 year. One provision unites three requirements: the importer must hold medical authorization, the import is covered by this one permit only, and the permit's term is strictly limited — one year.
The procedural framework
The procedural side of the application is the same for both blocks: the permit seeker submits a written application under the procedure of the General Administrative Code; the application must indicate the type of permit requested; the attached documents follow the seeker's legal form. A receipt for payment of the permit fee is a mandatory element of the application. Demanding additional documents is admissible only by law — this principle also applies fully to products under special control and gives the applicant procedural predictability. The grounds for refusal likewise follow from the general framework: a defective application not corrected in time, failure to satisfy the permit conditions, or deprivation by court judgment of the right to act in the sphere; refusal on any other motive is unlawful.
A comparison of the two blocks creates a clear picture. For radioactive materials the permit is tied to the type of operation: import, export, transit, return — each is defined as the subject of the same permit, and the importer plans the documentation accordingly. For medicinal products the permit is tied to the category of product: whatever the operation — import or export — it is covered by the separate permit for specially controlled products. Organizational preparation follows from these two approaches: for radioactive materials the central question is the completeness of authorization — the basis of activity, the operational permits and the waste management plan must be perceived as one whole; for medicinal products the central question is the qualification of the product — whether the specific product enters the list of special control and whether its foreign circulation is covered by the respective permit. The radiopharmaceutical rule is a bridge between the two blocks and shows exactly how the legislator resolves the conflict where two regimes operate simultaneously: medical authorization is the condition, one permit suffices, and the term is reduced to one year. Such structural thinking — the separation of category, operation and term — is the foundation of a successful import project.
The catalogue includes the permit for the import or export of specially controlled medicines as a separate type, and a special rule exists for this circle: on the import of radiopharmaceutical preparations for medical purposes, a person holding an authorization for nuclear and radiation activity receives the corresponding permit provided by the catalogue, valid for 1 year. Thus with radiopharmaceuticals two factors operate at once — the special-control regime and the medical purpose — and their combination determines the circle of the organ and the term that decides the application.
Frequently Asked Questions
Below we answer frequently asked questions on this topic.
For what term is the radiopharmaceutical import permit issued?
For 1 year — to a person holding an authorization for nuclear and radiation activity, for medical purposes.
What does the corresponding catalogue type cover?
The permit for the import or export of specially controlled medicines.
For whom is this regime accessible?
For authorized persons — the special rule concerns precisely this circle; others act under the general permit procedure.
How We Help on Legal.ge
Decisions connected with specially controlled substances depend on precise normative definition. The lawyers of Legal.ge will determine which permit and which rule apply to your case and prepare the application. Write to us on Legal.ge.