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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 not yet registered — may be manufactured, and what follows from acting without a permit. The Law of Georgia on Drugs and Pharmaceutical Activities answers these three questions respectively with trial standards, the licensing regime for manufacture, and an administrative fine. This page assembles that framework from the standpoint of the organisers of vaccine trials — sponsors, manufacturers and investigating centres.
The trial framework: standards and volunteers
Under Article 5¹ of the law, preclinical and clinical trials of a pharmacological product in Georgia are conducted in accordance with the standards and guidelines approved by the minister — which means that the documentation and procedures of a vaccine trial must obey precisely this approved framework. The rights of patients and healthy volunteers participating in a trial are protected by Georgian legislation. As for healthy volunteers, the law is strikingly specific: they may undergo a bioequivalence study of a medicinal product, a pharmacokinetic study of a pharmacological product developed in Georgia, and a study permitted on a market subordinate to the control of a foreign or international regulatory state authority for pharmaceutical products, conducted on healthy volunteers.
For biological medicinal products — and a vaccine belongs to exactly this circle — the law adds a further condition: a clinical trial of a pharmacological product intended as a progressive-therapy medicinal product is admissible if the product is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authority to manufacture biological medicinal products. At the same time, conducting clinical trials using the specific products and means defined by law is impermissible.
The sponsor's insurance and participant protection
The central mechanism protecting a vaccine trial participant is insurance. Before a clinical trial begins, the sponsor — the person, company, institution or organisation responsible for initiating, managing or funding the trial — must arrange insurance of the trial's risk and liability for the period of the trial's conduct. The insurance must provide for reimbursement or compensation of a participating person's treatment costs, to the extent they were needed for participation. Given the specificity of vaccine trials — where the volunteer is a healthy person — the configuration of the insurance deserves particular attention: the policy should also cover the costs that may befall the volunteer in connection with possible complications after the trial.
Manufacturing an unregistered vaccine for the trial
The practical question of a vaccine trial is this: how is a product manufactured that will obtain registration only after the trial? Article 12 of the law answers: the manufacture of a pharmaceutical product is subject to a licensing regime, but the manufacture in Georgia of an unregistered pharmaceutical product is allowed for the purpose of its registration, for preclinical and clinical trials, and for export. This means that creating the vaccine needed for a trial is legally possible, and it is done on the basis of a defined purpose.
The manufacturing permit is issued by the agency. Georgia selectively recognises a list of international, regional and national good-manufacturing-practice standards, which is recognised by the Government of Georgia. The responsibility of the manufacturer of a batch also matters: it is responsible for the safety, quality and efficacy of the pharmaceutical product manufactured — and for a batch produced for a trial, this responsibility likewise remains with it.
Permits and the fine
Conducting a clinical trial of a vaccine requires a permit. Under Article 37² of the law, conducting a clinical trial of a pharmacological product without a permit triggers a fine of GEL 4 000, and the same act committed repeatedly — a fine of GEL 8 000. The same article also punishes activity without a manufacturing permit: the manufacture, export or import of a pharmaceutical product subject to special control and activity without an authorised pharmacy all fall under one and the same sanction regime. Thus the organiser of a vaccine trial faces two permit risks: the trial permit and, where applicable, the manufacturing permit.
Frequently asked questions
May an unregistered vaccine be manufactured for a trial?
Yes. Under Article 12 of the law, the manufacture in Georgia of an unregistered pharmaceutical product is allowed for its registration, for preclinical and clinical trials and for export — under a manufacturing permit issued by the agency.
Which trials may be conducted on healthy volunteers?
Under Article 5¹: a bioequivalence study of a medicinal product, a pharmacokinetic study of a product developed in Georgia, and a study permitted on a market under the control of a foreign or international regulator.
Who arranges the participants' insurance?
The sponsor — before the trial begins, for the trial's duration, so that reimbursement or compensation of a participant's treatment costs is provided for.
What fine applies to acting without a permit?
Activity without a trial or manufacturing permit triggers a fine of GEL 4 000, and on repeated commission — GEL 8 000.
How We Help on Legal.ge
We build the complete legal route of a vaccine trial: we determine which standards and guidelines fit your project and how they should be reflected in the trial documentation; we examine the licensing grounds for manufacturing an unregistered product; we analyse the sponsor's insurance requirements and calculate the permit risks. Contact us for a legal plan of trial preparation that stays clear of the sanctions zone.