Tenders Are Invited For Antineoplastic And Immunomodulating Agents – Lp For Autologous Cell Therapy - Ciltakabtagen Autoleucel - 2026

Antineoplastic And Immunomodulating Agents – Lp For Autologous Cell Therapy - Ciltakabtagen Autoleucel - 2026. Cytostatic Agent For Car-T Therapy (Ciltakabtagen Autoleucel) - Infusion Bag Containing A Cell Dispersion Of 3.2X10⁶ To 1X10⁸ Viable Anti-Bcma Car-Positive T-Lymphocytes. The Expected Annual Volume Is 10 Infusion Bags Containing An Individually Determined Amount Of The Active Ingredient, Atc L01xl05 Dose Means An Infusion Bag For Single Application Containing A Specified Active Ingredient In An Amount Determined Individually According To The Needs Of A Specific Patient. The Medicinal Product Offered Must Meet The Requirements Of Súkl. Registration Of Súkl Is A Necessary Condition For The Standard Use Of Medicinal Products Within The Provision Of Health Care According To § 8, Paragraph 1 Of Act No. 378/2007 Coll., On Medicinal Products. The Participant Proves The Fulfillment Of This Condition By Indicating The Valid Súkl Code Of The Offered Medicinal Product In The Relevant Column Of The Table For Supplementing The Bid Prices, Which Is The Content Of Annex No. 1 Of The Tender Documentation (See Point 9.2.). The Medicinal Product Is Indicated For The Treatment Of Adult Patients With Relapsed And Refractory Multiple Myeloma Who Have Received At Least One Prior Therapy Including An Immunomodulator And A Proteasome Inhibitor And Who Have Shown Disease Progression During The Last Treatment And Are Refractory To Lenalidomide. In View Of The Fact That The Production Of Medicinal Products For Autologous Immunocellular Therapy Involves Highly Demanding And Specific Procedures And Is Conditional On The Collection Of Biological Material From Patients, The Contracting Authority Allows The Conclusion Of A Separate Contract/Separate Contracts, Regulating The Detailed Conditions Of Cooperation And Defining The Responsibility Of Individual Specialist Workplaces In Various Stages Of The Production And Therapeutic Process (Collection And Processing Of Biological Material, Conditions For Handling The Product, Ensuring The Quality Of The Product, Process Records, Qualification And Certification, Etc.). However, The Content Of Any Of These Contracts Must Not Conflict With The Terms Of This Tender Documentation, Incl. Terms Of The Purchase Contract.