Selective Control and the Agency's Supervision
Pharmacy compliance is assessed within the framework of the Law of Georgia on Medicines and Pharmaceutical Activity. Under Article 11, the agency is obliged to conduct risk-assessment-based selective control of the distributors of pharmaceutical products; during the control it is empowered to inspect the distributors' observance of the rules established for traceability and of storage conditions, and in cases provided by legislation — to purchase a product from distributors for laboratory testing.
Article 11-1 refines the control mechanisms: the agency uses laboratory control and the mechanisms of administrative control of the distribution chain, and mainly the administrative one. Laboratory control is applied where there is a high risk of falsification or defect, and in exceptional cases the agency has the discretionary power to apply it without regard to the formal criteria — but not exceeding 10 percent of the inspection frequency within one year. The documentary trace of the distributor stands at the centre of this model: where accounting and notifications are executed in time, administrative control remains a comfortable procedure for the party. For a pharmacy, supervision is thus systemic: the documentary chain and storage conditions are always inspectable, the laboratory — by risk.
The Obligations of the Distributor
Under Article 17, the principle of regulating the distribution of pharmaceutical products is the provision of storage and dispensing conditions and the adequate maintenance of the documentation necessary for recording the series of the product sold. The distributor is obliged to record the series of products intended for sale, to introduce modern means of storage and to protect the product from the negative influence of environmental factors — temperature and humidity — keeping it in full compliance with the sanitary-hygienic and technical conditions provided by the instruction.
The same article governs other operational rules: expired and defective products are kept separately, isolated from other products until destruction; and where the distributor has a well-founded suspicion that a product lacks market authorization, is falsified or defective, it is obliged to suspend its sale immediately and notify the agency without delay. This last norm is precisely the active participation the agency expects from every distributor at an inspection. The practical meaning of compliance lies exactly here: every action established by law — accounting, storage, isolation, notification — must be distributed among the personnel in advance, fixed by an internal instruction and verifiable by a documentary trace.
Participation in Side-effect Monitoring
Under Article 26, the unified system of monitoring the side effects of medicines is joined by the treating physicians of the medical-prophylactic network, the specialists of medical institutions and the structures of the ministry; the coordination of the system and the analysis of the information are carried out by the agency, which collects and generalizes information on adverse effects, exchanges it with the medical services of other countries and the World Health Organization, and prepares recommendations.
What matters to the distributor here is a clear obligation: subjects of the circulation and use of medicines are obliged to supply the agency with information on every case of a side effect and on interactions not indicated in the instruction. This informational discipline is part of the full chain — a signal taken in a pharmacy ultimately affects the circulation of the product.
Liability and Fines
Article 37-10 establishes the sanction for violating the conditions determined by the technical regulation on the sanitary-hygienic and technical conditions of a pharmacy and of a retail trade object: the violation entails a fine of 500 GEL, and the same act committed repeatedly — a fine of 1 000 GEL. The amount is small, but repetition arises precisely where a defect is systemic — and a systemic defect grows, for the licensee, into a conversation already in the context of compliance. A sanction always attaches to a separate fact: every unsatisfied condition, every unrecorded series and every late notification is a separate violation, and their accumulation burdens the reputational price as well.
Frequently Asked Questions
What does the agency inspect during selective control?
The observance of traceability rules and storage conditions; it may also purchase a sample for laboratory study (Article 11).
What burdens the distributor?
Series accounting, modern storage means, compliance with the conditions of the instruction, isolation of expired products and immediate reaction to suspect products (Article 17).
What fine exists for violating the conditions?
500 GEL, and upon repetition — 1 000 GEL (Article 37-10).
Must a pharmacy report side effects?
Yes — information on every case must be supplied to the agency (Article 26).
How We Help on Legal.ge
Pharmacy compliance is a matter of readiness: series accounting, storage conditions, the order of documentation and the procedure for reacting to suspect products — these are the elements an inspection studies, and they must be embedded in daily discipline, not on the eve of an inspection.
The lawyers working on Legal.ge will help you inventory compliance, prepare internal procedures and a reaction rule for suspect products, accompany relations with the agency and assess liability for sanctions. Contact us for a consultation — readiness costs less than a repeated fine.