Tenders Are Invited For Pharmaceutical Products – Zp/91/2026 Successful Delivery Of A Medicinal Product For The Needs Of A Clinical Trial Carried Out As Part Of The B Cell Depletion Therapy Project To Improve Outcomes Of Steroid-Sensitive Nephrotic Syndrome In Adults-Booster Trial”

Pharmaceutical Products – Zp/91/2026 Successful Delivery Of A Medicinal Product For The Needs Of A Clinical Trial Carried Out As Part Of The B Cell Depletion Therapy Project To Improve Outcomes Of Steroid-Sensitive Nephrotic Syndrome In Adults-Booster Trial”. The Subject Of The Order Is The Successive Delivery Of A Medicinal Product For The Needs Of A Clinical Trial Carried Out As Part Of The B Cell Depletion Therapy To Improve Outcomes Of Steroid-Sensitive Nephrotic Syndrome In Adults-Booster Trial Project, Financed By The Medical Research Agency Under The Abm/2023/1 Competition. The Supply Of Medicinal Products Should Be Carried Out In Accordance With The Principles Of Gcp, Gmp And Gdp. 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. 50 Ml, Quantity: 150 Vials, With A Shelf Life Of Not Less Than 14 Months From The Date Of Delivery Of The Product. A Medicinal Product Containing The Active Substance Rituximab Must Be Authorized For Marketing In The European Union. The Summary Of Product Characteristics Containing The Active Substance Rituximab Should Include Information On The Possibility Of Using An Alternative Drug Delivery Scheme Consisting In Administering The Second And Subsequent Infusions At A Faster Rate Using A Drug Solution Of 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 Rituximab Medicinal Product To A Maximum Of 20 Clinical Trial Centers In Poland Indicated By The Ordering Party. Deliveries Of The Drug Will Be Made According To Partial Orders Placed By An Authorized Representative Of The Ordering Party, Based On The Demand Resulting From The Recruitment Process And Inclusion Of Patients In The Clinical Trial. Orders Will Be Placed By Phone Or To The E-Mail Address Provided By The Contractor. The Maximum Lead Time For A Partial Order Is 5 Business Days. The Final Dates And Quantities Of Products Will Be Agreed By The Ordering Party And The Selected Contractor During The Implementation Of The Contract. A Maximum Of 10 Deliveries Of A Given Drug Per Center Are Expected. In Addition To Partial Orders, The Need For Urgent Orders In A Limited Number Is Allowed (No More Than 2 Per Year For A Given Research Center). Urgent Orders Will Be Reported To The Contractor At The Telephone Number And E-Mail Address Provided By Him By An Authorized Representative Of The Ordering Party. The Maximum Time For Delivery Of The Medicine From Placing An Urgent Order Is 2 Business Days. 3. The Contractor Is Obliged To Provide A List Containing Information About The Contents Of A Given Package And The Assigned Batch Numbers. The Contractor Should Have A Valid Permit For Wholesale Trade In Medicinal Products, I.E. Be Listed In The Register Of Permissions To Operate A Pharmaceutical Wholesale Store Kept By The Chief Pharmaceutical Inspectorate, In Accordance With Art. 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 Permissions To Operate