Poland – Vaccines – Hepatitis B vaccine for persons with renal insufficiency, including those undergoing dialysis. Lots: 1-3; procedure reference: ZZP.ZP.411.134.2026

Opportunity description

The subject matter of the contract is the supply of a hepatitis B vaccine for persons with renal insufficiency, including those undergoing dialysis, under the terms specified in the SWZ. 1. The subject matter of the contract is the supply of a hepatitis B vaccine for persons with renal insufficiency, including those undergoing dialysis, under the terms specified in the SWZ. 2. Total quantity (purchase volume): 5 000 doses. 3. When selecting the most advantageous tender, the Contracting Authority reserves the right to reduce the purchase of the medicinal product, but by no more than 20% of each lot of the above-mentioned subject matter of the contract, if the amount allocated for performance of the contract is exceeded or if objective and justified needs arise, in particular changes in demand among patients. 4. Pursuant to Art. 256 of the Pzp Act, the Contracting Authority may cancel the procurement procedure before the deadline for submission of tenders, as applicable, if circumstances arise that render further conduct of the procedure unjustified. 5. Pursuant to Art. 257 of the Pzp Act, the Contracting Authority may cancel the procurement procedure if the public funds that the Contracting Authority intended to allocate to financing all or part of the contract have not been awarded to it. 6. By virtue of the Act of 16 November 2022 amending the Act on the professions of physician and dentist and certain other acts (Journal of Laws of 2022, item 2270), the Act of 27 August 2004 on healthcare services financed from public funds (Journal of Laws of 2025, item 1461) included financing by the National Health Fund of the acquisition of vaccines used for mandatory vaccinations under the Protective Vaccination Programme, as well as vaccines and other immunological medicinal products constituting a reserve and used in the event of an epidemic threat or epidemic. 7. Pursuant to Art. 97(3)(3d) of the Act on healthcare services financed from public funds, the scope of the Fund’s activities also includes, in particular: financing the purchase of vaccines referred to in Art. 18(5) of the Act of 5 December 2008 on preventing and combating infections and infectious diseases in humans, and medicinal products referred to in Art. 18a(2) of that Act. 8. The contract must be performed in accordance with the requirements specified in the SWZ and in the Draft Contractual Provisions. 9. Subject-matter evidence: Pursuant to Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract, the tender evaluation criteria or the requirements related to performance of the contract, the Contracting Authority requires Contractors to submit the following documents: • A marketing authorisation for the medicinal product, valid on the tender submission date, issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or • A marketing authorisation for the medicinal product, valid on the tender submission date, issued by the Council of the European Union or the European Commission. 9.1. Pursuant to Art. 107(1) of the Pzp Act, the Contractor is required to submit the above-mentioned subject-matter evidence together with the tender and should exercise all due care to ensure that these documents are complete and contain all necessary information enabling the Contracting Authority to verify their correctness. 9.2. The marketing authorisation for the medicinal product must be valid and current on the tender submission date. 9.3. The composition of the preparation and the packaging must comply with the contents of the documents referred to in point 9. 9.4. If the document expires, the Contractor is required to provide the Contracting Authority, together with the documents referred to in point 9, with an additional document declaring that an application to extend the validity of the marketing authorisation for the medicinal product was submitted within the proper time or, if obtained, a valid marketing authorisation for the medicinal product. 9.5. The Contractor is required to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation for the medicinal product. 9.6. The above-mentioned documents must have a validity period covering the entire period of contract performance. 9.7. The documents referred to above shall be submitted in the manner provided for in the provisions issued pursuant to Art. 70 of the Pzp Act. 9.8. Pursuant to Art. 107(2) of the Pzp Act, the Contracting Authority provides for the possibility of supplementing the above-mentioned subject-matter evidence once, within the time limit set by the Contracting Authority. 9.9. Subject-matter evidence drawn up in a foreign language shall be submitted together with a translation into Polish. There is no obligation to translate into Polish proper names, customarily used technical terminology, trademarks, trade names or indications of the origin of goods. 1. The subject matter of the contract is the supply of a hepatitis B vaccine for persons with renal insufficiency, including those undergoing dialysis, under the terms specified in the SWZ. 2. Total quantity (purchase volume): 10 000 doses. 3. When selecting the most advantageous tender, the Contracting Authority reserves the right to reduce the purchase of the medicinal product, but by no more than 20% of each lot of the above-mentioned subject matter of the contract, if the amount allocated for performance of the contract is exceeded or if objective and justified needs arise, in particular changes in demand among patients. 4. Pursuant to Art. 256 of the Pzp Act, the Contracting Authority may cancel the procurement procedure before the deadline for submission of tenders, as applicable, if circumstances arise that render further conduct of the procedure unjustified. 5. Pursuant to Art. 257 of the Pzp Act, the Contracting Authority may cancel the procurement procedure if the public funds that the Contracting Authority intended to allocate to financing all or part of the contract have not been awarded to it. 6. By virtue of the Act of 16 November 2022 amending the Act on the professions of physician and dentist and certain other acts (Journal of Laws of 2022, item 2270), the Act of 27 August 2004 on healthcare services financed from public funds (Journal of Laws of 2025, item 1461) included financing by the National Health Fund of the acquisition of vaccines used for mandatory vaccinations under the Protective Vaccination Programme, as well as vaccines and other immunological medicinal products constituting a reserve and used in the event of an epidemic threat or epidemic. 7. Pursuant to Art. 97(3)(3d) of the Act on healthcare services financed from public funds, the scope of the Fund’s activities also includes, in particular: financing the purchase of vaccines referred to in Art. 18(5) of the Act of 5 December 2008 on preventing and combating infections and infectious diseases in humans, and medicinal products referred to in Art. 18a(2) of that Act. 8. The contract must be performed in accordance with the requirements specified in the SWZ and in the Draft Contractual Provisions. 9. Subject-matter evidence: Pursuant to Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract, the tender evaluation criteria or the requirements related to performance of the contract, the Contracting Authority requires Contractors to submit the following documents: • A marketing authorisation for the medicinal product, valid on the tender submission date, issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or • A marketing authorisation for the medicinal product, valid on the tender submission date, issued by the Council of the European Union or the European Commission. 9.1. Pursuant to Art. 107(1) of the Pzp Act, the Contractor is required to submit the above-mentioned subject-matter evidence together with the tender and should exercise all due care to ensure that these documents are complete and contain all necessary information enabling the Contracting Authority to verify their correctness. 9.2. The marketing authorisation for the medicinal product must be valid and current on the tender submission date. 9.3. The composition of the preparation and the packaging must comply with the contents of the documents referred to in point 9. 9.4. If the document expires, the Contractor is required to provide the Contracting Authority, together with the documents referred to in point 9, with an additional document declaring that an application to extend the validity of the marketing authorisation for the medicinal product was submitted within the proper time or, if obtained, a valid marketing authorisation for the medicinal product. 9.5. The Contractor is required to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation for the medicinal product. 9.6. The above-mentioned documents must have a validity period covering the entire period of contract performance. 9.7. The documents referred to above shall be submitted in the manner provided for in the provisions issued pursuant to Art. 70 of the Pzp Act. 9.8. Pursuant to Art. 107(2) of the Pzp Act, the Contracting Authority provides for the possibility of supplementing the above-mentioned subject-matter evidence once, within the time limit set by the Contracting Authority. 9.9. Subject-matter evidence drawn up in a foreign language shall be submitted together with a translation into Polish. There is no obligation to translate into Polish proper names, customarily used technical terminology, trademarks, trade names or indications of the origin of goods. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.