When entering the site, the Agency of Medical and Pharmaceutical Activities conducting the inspection informs the representative of the institution about:- 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.