Romania – Facilities management services – DELEGARE PRIN CONCESIUNE DE SERVICII A PRODUCȚIEI DE RADIOFARMACEUTICE, IN CADRUL LABORATORULUI DE RADIOFARMACEUTICE –CENTRUL DE CERCETARE FUNDAMENTALĂ ÎN MEDICINA TRANSLAȚIONALĂ – TRANSCEND

The proposed contract is a service concession contract, as defined in Law No. 100/2016, through which IRO Iași (the grantor) delegates the management of the production of the radiopharmaceutical FDG to a selected economic operator (the concessionaire). The fulfilment modality involves the concessionaire taking over and operating the IRO's radiopharmacy laboratory at its own risk and expense, ensuring the continuous production of FDG for both the internal needs of IRO and other medical units in the region. The concessionaire will need to make the initial investments necessary for the effective operation of the laboratory (additional acquisitions, calibrations, personnel, GMP documentation, etc.), obtain all the necessary authorizations and approvals for operation (CNCAN authorization for the use of radioactive sources, GMP certification, sanitary authorizations, etc.), and start the production of FDG within the term assumed in the offer. The deadline by which any economic operator interested in participating in the procedure for the award of the concession contract has the right to request clarification or additional information regarding the award documentation is 20 days before the deadline for the submission of tenders. The deadline within which the contracting authority will respond clearly and completely to all requests for clarification/additional information is the 16th day before the deadline for the submission of tenders. The contracting authority mentions that it will only respond to clarification requests submitted by economic operators up to the set deadline. Any request for clarification must be sent to the email address: [email protected], within the specified term.