The regulation of control in the field of medical and pharmaceutical activities in Georgia
According to the new rules, regulators can come to the clinic with an inspection without warning
Nato Kavtaradze, lawyer, attorney for JUST Advisors
August 16, 2023
On August 1, 2023, the Government of Georgia issued Resolution No. 278 to approve procedures, rules, and conditions governing control in the field of medical and pharmaceutical activities, in accordance with the Law on Health Protection of Georgia. The resolution grants the Medical and Pharmaceutical Activity Control Agency the authority to conduct unannounced inspections of facilities subject to state control at any time of day or night. The agency will ensure the compliance of medical and pharmaceutical institutions with the norms outlined in this resolution. In the event of violations of legal norms, the agency is empowered to take measures established by legislation.
The agency conducts inspections of medical and pharmaceutical institutions through two types of implementation:
- On-site Inspection: This involves physically inspecting the place or address of the medical and pharmaceutical institution.
- Documentation and Inquiry: The agency may also request information, documents, and/or conduct questioning of the involved parties without entering the premises of the medical and pharmaceutical institution.
- Written Complaints: Submission of a written complaint by the patient or their representative.
- Critical Incidents: Occurrence of critical incidents such as the death of a pregnant woman, newborn, or child.
- Administrative Appeals: Submission of an appeal to the administrative body.
- Mass Information: Discovery of a serious health complication or sudden death of a patient, brought to attention through mass information channels.
- Written Complaints: Submission of a written complaint by the user or their representative regarding the quality of the pharmaceutical product.
- Administrative Appeals: Filing an appeal with the administrative body.
- Public Information on Health and Safety: Dissemination of public information indicating a risk to human life and/or health.
- Preservation of Evidence: Public information suggesting circumstances that may be linked to the destruction of evidence
The agency has the authority to initiate inspections of medical and pharmaceutical institutions subject to state control through selective control.
When entering the site, the Agency of Medical and Pharmaceutical Activities conducting the inspection informs the representative of the institution about:
In the process of conducting control over the medical and pharmaceutical establishment, within the scope of the agency's authority, the inspected establishment is required to:
The agency conducts facility inspections through an authorized person, involving a representative of the medical institution.
If the representative of the medical and pharmaceutical institution declines participation in the control process, the inspection procedure will not be halted.
During the control process, the Agency is obligated to uphold the confidentiality of the evidence acquired from the object in accordance with the applicable legislation.
The Agency is empowered, based on the inspection of the medical and pharmaceutical establishment, to:
The agency is authorized to impose fines on the medical and pharmaceutical establishment as follows:
- The specific individual administrative-legal act issued by the director of the agency.
- Information regarding the measures to be implemented.
- Explanation of the rights and duties applicable to the representative of the object undergoing inspection.
In the process of conducting control over the medical and pharmaceutical establishment, within the scope of the agency's authority, the inspected establishment is required to:
- Provide any document necessary for the effective inspection of the facility.
- Allow the agency to make copies and/or extracts of any original document if deemed necessary.
- Submit documents in both electronic and material form.
- Offer an explanation on any issue by the person in charge of the facility.
The agency conducts facility inspections through an authorized person, involving a representative of the medical institution.
If the representative of the medical and pharmaceutical institution declines participation in the control process, the inspection procedure will not be halted.
During the control process, the Agency is obligated to uphold the confidentiality of the evidence acquired from the object in accordance with the applicable legislation.
The Agency is empowered, based on the inspection of the medical and pharmaceutical establishment, to:
- Impose an administrative fine on the facility.
- Suspend the right/license/permit to operate a high-risk medical institution.
- Make any other decision stipulated by the legislation of Georgia.
The agency is authorized to impose fines on the medical and pharmaceutical establishment as follows:
- For the violation of medical activity license conditions, the amount of which shall not exceed 5,000 GEL.
- For the violation of medical activity permit conditions, the amount of which shall not exceed 15,000 GEL.
The consideration of partial or complete suspension of the activity of the control object is undertaken by the commission of the agency. The decision of the commission is finalized and approved through an administrative-legal act issued by the director of the agency.
Following a decision to completely or partially suspend activities in the medical field, the agency is obligated to approach the court within 24 hours, seeking approval for the suspension of the right/license/permit for high-risk medical activity. Any petition submitted in violation of the specified deadlines will be deemed null and void, resulting in the restoration of the right to operate the medical institution.
Upon correction of the violation by the high-risk medical facility in accordance with the agency’s decision, the restoration of the right/license/permit for medical activity will be initiated within 5 working days from the date of application. If there is a decision to refuse the resumption of medical activity, the concerned party has the right to appeal this decision in court.
Following a decision to completely or partially suspend activities in the medical field, the agency is obligated to approach the court within 24 hours, seeking approval for the suspension of the right/license/permit for high-risk medical activity. Any petition submitted in violation of the specified deadlines will be deemed null and void, resulting in the restoration of the right to operate the medical institution.
Upon correction of the violation by the high-risk medical facility in accordance with the agency’s decision, the restoration of the right/license/permit for medical activity will be initiated within 5 working days from the date of application. If there is a decision to refuse the resumption of medical activity, the concerned party has the right to appeal this decision in court.
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MARIA GUSEINOVA
Leading Manager of Commercial Department
Leading Manager of Commercial Department