The legal framework of pharmacy licensing
Pharmaceutical activity in Georgia is regulated by the law on licenses and permits, which governs a whole series of permits connected with medicinal products. For the pharmacy direction, the types of permits established by Article 24 of the law are of particular importance: the permit for a clinical trial of a pharmacological product, the permit for pharmaceutical production — of medicinal products, except narcotic products — and the permit for an authorized pharmacy. Each of these permits requires its own administrative proceeding, so before starting you must know exactly which type of permit your planned activity calls for.
Types of pharmacy permits
Under Article 24 of the law, the clinical trial permit grants the right to carry out research activity on pharmacological products. The pharmaceutical production permit is defined for the production of medicinal products, except narcotic products — this carve-out matters, because production connected with narcotic products is regulated separately. The authorized pharmacy permit is the basis for opening and operating a pharmacy. Beyond these three, the law also contemplates permits connected with the import and export of medicinal products, so an integrated pharmaceutical business may require several permits at once.
The permit application and documentation
A permit seeker submits a written application to the issuing authority; its submission, consideration and acceptance for processing take place under the procedure established by Chapter VI of the General Administrative Code of Georgia. The application must satisfy the requirements of Article 78 of that Code, contain an indication of the type of permit sought and a list of attached documents. A private-law legal entity or individual entrepreneur attaches extracts from the public registry; a natural person attaches copies of identification documents; a public-law legal entity attaches certified copies of its founding documents. The application is also accompanied by proof of payment of the permit fee, whose amount is determined by the law on license and permit fees. Additional attached documents may be prescribed only by law — an important safeguard against administrative pressure.
Where the specifics of the activity so require, additional permit conditions may be established by law or, on its basis, by a normative act of the government. Confirmation of the factual circumstances satisfying such conditions takes place in separate administrative proceedings: copies of the application are transferred to another administrative authority no later than 3 days after compliance is established, and that authority adopts a decision no later than 15 days from the submission of the copies; extension of this period is possible through a substantiated motion submitted no later than 5 days from receipt of the copies, and the decision is submitted to the issuing authority no later than 17 days from the submission of the copies. If within the established period neither confirmation nor a substantiated refusal takes place, the additional permit conditions are deemed satisfied.
The issuance rule and subsequent obligations
The permit issuer adopts a decision on issuance under the simplified administrative proceeding, in the form defined by legislation. The permit holder then has continuing obligations: where the data indicated in the application change, the holder must notify the issuer in writing and submit the relevant documents within 7 days of the change. If the action provided for by the permit is carried out by a legal entity, its branch also has the authority to carry it out, provided that before the branch performs the permitted action the holder notifies the issuer in advance about the satisfaction of the conditions. Establishing an additional condition or regime implying that a separate permit must be obtained for the branch is impermissible.
Transitional regulation for authorized pharmacies
The law contains an important transitional norm for pharmacies: a pharmacy holding a permit for the arrangement of a Group I pharmacy does not need to obtain a repeated permit in the form of an authorized pharmacy permit. Upon such a pharmacy's application, the issuing authority is obliged to ensure the change of the permit form free of charge with the appropriate permit. This norm relieves businesses of the costs of re-formalization and signals that upon a change of regulation the administration must not re-establish substantive requirements.
Frequently Asked Questions
Which permits does a pharmaceutical business need?
The law defines permits for a clinical trial of a pharmacological product, for pharmaceutical production — of medicinal products except narcotic ones — and for an authorized pharmacy; depending on the planned activity, several permits may be required at once.
Within what period is the decision on additional permit conditions adopted?
In separate administrative proceedings, the other authority must submit its decision within 15 days of the submission of the copies of the application.
What privilege does a Group I pharmacy have?
No repeated permit is required — upon its application, the issuing authority changes the permit form free of charge with the appropriate permit.
How We Help on Legal.ge
Our team assists in precisely determining the required type of permit, in preparing the application and documentation, in the proceedings on additional permit conditions, in assessing the branch regime, and in the procedure of changing the transitional permit form for an authorized pharmacy. Every step is planned on the basis of the exact norms of the law, so that the licensing process remains predictable for you.