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.