COAGULATION FACTOR VIII CONCENTRATE (PLASMA-DERIVED OR RECOMBINANT) with successive deliveries to Regional Blood Donation and Blood Transfusion Centers and patient homes

1. The subject of the order includes successive deliveries in 2026-2027 of coagulation factor VIII concentrate (plasma-derived or recombinant) to ensure continuity of treatment for patients with hemophilia A - hereinafter referred to as "coagulation factor", with Rp or Rpz availability category, to direct recipients indicated by the National Blood Centre (hereinafter NCK) or another authorized entity - Regional Blood Donation and Blood Transfusion Centers (hereinafter RCKiK), as part of the health policy program of the minister competent for health entitled "National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for the years 2024-2028", hereinafter referred to as the "MZ program", as well as in 2026-2027, the delivery of administration kits or infusion kits for vascular access ports for patients indicated by the National Blood Centre (hereinafter NCK) or another authorized entity, organization of deliveries to patients' homes, which is understood as the patient's place of residence or permanent stay, for the indicated number of patients, disposal of disposable equipment, and monitoring of drug consumption, under the terms and conditions specified in the SWZ. 2. Total quantity (basic purchase volume for 2026-2027): 82,800,000 IU. 3. Expiry date of the medicinal product, dosage proportions in each delivery, composition of the infusion kit for vascular access ports - in accordance with the SWZ. 4. The coagulation factor concentrate must be delivered with a kit for its administration. 5. Pursuant to art. 256 of the Public Procurement Law. The Contracting Authority may annul the procurement procedure before the expiry of the deadline for submitting tenders if circumstances arise that make further proceedings unjustified. 6. Pursuant to art. 257 of the Public Procurement Law. The Contracting Authority may annul the procurement procedure if the public funds intended by the Contracting Authority to finance all or part of the order have not been granted to it. 7. The Contracting Authority reserves the right to annul the procedure or withdraw from the contract without compensation to the Contractor with effect ex nunc, if at least one of the following grounds occurs: 7.1. The National Blood Centre does not receive full or partial funding for the implementation of the health policy program entitled "National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for the years 2024-2028" in the expected year of contract execution, which would prevent the contract from being fulfilled. 7.2. The Minister of Health decides not to modify, to modify, to abandon, or to suspend the implementation of the "National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for the years 2024-2028" or makes changes to the program's content that result in the deletion of the medicinal product that is the subject of the order/contract. 7.3. The procurement of medicinal products covered by this public procurement procedure, carried out within the framework of the "National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for the years 2024-2028" by the National Blood Centre through the Public Procurement Office at the Minister of Health, is to be financed from funds, the final confirmation of which will be possible after the adoption and approval of the National Health Fund's financial plan. In view of the above, the National Blood Centre - as the Contracting Authority/Purchaser - indicated in the tender notice for this open tender, and/or in the remaining documentation relating to the subject order, has foreseen the possibility of annulling this public procurement procedure and withdrawing from the contract. The Contracting Authority reserves the right to claim no compensation from the National Blood Centre or the Ministry of Health in the event of annulment of the procedure or withdrawal from the contract, subject to Chapter II, point 11 of the SWZ. 8. The Contractor will be obliged to prepare distribution plans for deliveries to Direct Recipients and patients, starting...