ZP/91/2026 Successive delivery of a medicinal product for the clinical trial carried out under the project "B cell depletion therapy to improve outcomes of steroid-sensitive nephrotic syndrome in adults - BOOSTER Trial"

The Medical University of Lodz in Poland from Europe region has released this tender for The subject of the order is the successive delivery of a medicinal product for the purposes of a clinical trial carried out under the project "B cell depletion therapy to improve outcomes of steroid-sensitive nephrotic syndrome in adults - BOOSTER Trial". ”, financed by the Medical Research Agency under the ABM/2023/1 call for proposals. The supply of medicinal products should be carried out in accordance with GCP, GMP and GDP principles. The subject of the order includes: 1. Purchase of the medicinal product Rituximab (trade name: RIXIMYO), Concentrate for solution for infusion, 10 mg/ml (500 mg), 1 vial of 50 ml, in a quantity of: 150 vials, with a shelf life of not less than 14 months from the date of delivery of the product. The medicinal product containing the active substance Rituximab must be authorized for marketing in the European Union. The Summary of Product Characteristics of the Medicinal Product containing the active substance Rituximab should include information on the possibility of using an alternative drug administration regimen consisting in administering the second and subsequent infusions at a faster rate using a drug solution with the same concentration as in the previous infusions (4 mg/ml in a volume of 250 ml). The initial infusion rate should be 250 mg/hour for the first 30 minutes, followed by 600 mg/hour for the next 90 minutes. 2. Transport of the medicinal product Rituximab to a maximum of 20 clinical trial sites designated by the Ordering Party in Poland. Deliveries of the drug will be made according to partial orders placed by an authorized representative of the Ordering Party, based on demand resulting from the recruitment and enrollment process of patients in the clinical trial. Orders will be placed by phone or to the email address provided by the Contractor. The maximum deadline for completing a partial order is 5 business days. The final deadlines and product quantities will be agreed upon by the Ordering Party with the selected Contractor during the execution of the contract. A maximum of 10 deliveries of a given drug per site is anticipated. In addition to partial orders, a limited number of urgent orders are permitted (no more than 2 per year for a given research site). Urgent orders will be notified to the Contractor at the telephone number and email address provided by the Ordering Partys authorized representative. The maximum time for drug delivery from the moment an urgent order is placed is 2 business days. 3. The Contractor is obligated to provide a list containing information about the contents of the given package and the assigned batch numbers. The Contractor must have a current permit for wholesale trade in medicinal products, i.e., be listed in the Register of Permits to Operate a Pharmaceutical Wholesale Store maintained by the Chief Pharmaceutical Inspectorate, in accordance with Article 83 of the Pharmaceutical Law and the Regulation of the Minister of Health of October 3, 2012,regarding the description of the IT system in which the Register of Pharmaceutical Wholesale Permits is maintained. Completion date: The order will be completed within 29 months from the date of signing the contract, but no later than May 31, 2029. with tender notice no. 703073-2026 published on 12 Oct 2026. The tender is due to expire on 09 Nov 2026. This tender is sourced from TED Europa and is eligible for suppliers interested in Pharmaceutical products. Interested bidders can obtain further information including complete bid documents or ways to participate by registering on Tender Impulse and referencing via Tender Impulse ID 15408897.