Poland – Vaccines – Vaccine against infections caused by rotaviruses, for mandatory vaccinations, lots: 1÷3

Opportunity description

The subject of the contract is the supply of a vaccine against infections caused by rotaviruses, for mandatory vaccinations, under the terms specified in the SWZ. 1.The subject of the contract is the supply of a vaccine against infections caused by rotaviruses, for mandatory vaccinations, under the terms specified in the SWZ. 2. Total number (purchase volume): 62 000 schedules. 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 of the contract, in the event that the amount allocated for performance of the contract is exceeded or objective and justified needs arise, in particular a change in demand among patients. 4. Pursuant to Art. 256 of the Pzp Act. The Contracting Authority may cancel the procurement procedure, as appropriate, before the deadline for submission of tenders 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 finance all or part of the contract have not been granted 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 2770), provisions were introduced into the Act of 27 August 2004 on healthcare services financed from public funds, according to which financing by the National Health Fund covers the acquisition of vaccines used for mandatory vaccinations carried out under the Protective Vaccination Programme, as well as vaccines and other immunological medicinal products constituting a reserve, used in the event of an epidemic threat or an epidemic. The consolidated text of this Act, published in the Journal of Laws of 2025, item 1461, is currently in force. 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 of the contract or the tender evaluation criteria or requirements related to performance of the contract, the Contracting Authority requires Contractors to submit the following documents: • A valid marketing authorisation for the medicinal product in the territory of the Republic of Poland, issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or • A valid marketing authorisation for the medicinal product 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 as at the tender submission date. 9.3. The composition of the preparation and packaging must comply with the content of the documents referred to in point 9. 9.4. Where the validity of a 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 in due 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 contract performance period. 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 and indications of the origin of goods. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.