About this service Regulating vaccine trials is a combination of three interconnected questions: under what rules a vaccine's clinical trial is conducted, how the product needed for the trial — one no
Drug RegulationThe Legal Framework for Approving a Clinical TrialA clinical trial of a pharmacological agent in Georgia is never a purely technical or medical undertaking: it is fully regulated by the Law of Georgia
Drug RegulationThe Two Market-Admission RegimesThe admission of a pharmaceutical product to the Georgian market operates under two regimes: the recognition regime and the national regime of state registration. The r
Drug RegulationThe Legal Basis for International ResearchIncluding Georgia in a multicentre international clinical trial is a manageable task when several interconnected norms of the Law of Georgia on Drugs and Phar
Drug RegulationMedical Device Clinical Trials and Regulation Clinical trials for medical devices differ substantially from pharmaceutical drug trials in both methodology and legal regulation. This category encompass
Drug RegulationMarking Requirements at RegistrationThe label and marking of a pharmaceutical product are an integral part of its state registration. The administrative part of the registration documents is submitted
Drug RegulationPhase I Research in the Georgian Legal OrderA phase I clinical trial in Georgia is associated first of all with healthy volunteers, and this is precisely why its approval demands particular precision.
Drug RegulationThe Legal Discipline of a Phase II/III ProtocolPhase II and III clinical trials are conducted on broad populations of patients, and it is at this stage that the principal data on a product's efficacy
Drug RegulationLegal Routes for Researching an Orphan ProductThe research and market admission of orphan drugs — medicines designed for rare diseases — are regulated in Georgia by the general norms of the Law on Dru
Drug RegulationViolations of Pharmaceutical Activity Rules and Their FinesThe law attaches a precise sanction to each breach of the pharmaceutical activity rules. The preparation or sale of a pharmaceutical product
Drug RegulationThe Legal Foundations of Pharmaceutical RegulationsGeorgian legislation on medicines and pharmaceutical activity rests on the Constitution of Georgia, international treaties and agreements, the law go
Drug RegulationClinical Research Law: The Participant's Legal Regime The law of clinical research in Georgia, from the participant's side, is governed by the Law on Patient Rights: it is there that the entire machin
Drug RegulationEssence, Scope and State Policy of Pharmaceutical LawThe legislation of Georgia on medicines and pharmaceutical activity comprises the Constitution of Georgia, international treaties and agreements, t
Drug RegulationData Protection and Exclusivity PeriodsThe approval process begins with the rule on data protection: the scientific-technical information about a registered product may not be used for a registration
Drug RegulationAbout this service Clinical trials law is the body of norms that determines how the state protects the person participating in a trial — and who answers when that protection fails. The Law of Georgia
Drug RegulationAbout this service A clinical trial agreement is the legal framework that binds the sponsor, the investigating clinic and the researcher: who funds and manages the trial, who conducts it at the site,
Medical DevicesA Medical Device Dispute: Two Legal Routes A dispute over a medical device in Georgia moves along two trajectories: the contractual one — repair, replacement or avoidance of the contract for a defecti
Medical DevicesThe Statutory Framework for Medical Devices Georgia has no separate statute dedicated to medical devices: their regulation rests on the Law of Georgia on Health Care. Under this law, the design, produ
