Hepatitis B vaccine for children, inj. 0.5 ml. Parts: 1-4; procedure reference: ZZP.ZP.411.132.2026 1. The subject of the contract is the supply of hepatitis B vaccine for children, inj. 0.5 ml, on the terms specified in the content of the SWZ....

Hepatitis B vaccine for children, inj. 0.5 ml. Parts: 1-4; procedure reference: ZZP.ZP.411.132.2026 1. The subject of the contract is the supply of hepatitis B vaccine for children, inj. 0.5 ml, on the terms specified in the content of the SWZ. 2. Total quantity (purchase volume): 80,000 doses. 3. When selecting the most advantageous tender, the Contracting Authority reserves the right to reduce the purchase of the medicinal product, however by no more than 20% of each part of the above subject of the contract, in the event of exceeding the amount allocated for the implementation of the contract or the emergence of objective and justified needs, in particular a change in demand among patients. 4. Based on Art. 256 of the Pzp Act, the Contracting Authority may cancel the contract award procedure accordingly before the expiry of the deadline for submission of tenders, if circumstances arise making further conduct of the procedure unjustified. 5. In accordance with Art. 257 of the Pzp Act, the Contracting Authority may cancel the contract award procedure if the public funds which the Contracting Authority intended to allocate to finance the whole 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 2270), in the Act of 27 August 2004 on health care services financed from public funds (Journal of Laws of 2025, item 1461), the financing by the National Health Fund of the acquisition of vaccines used for mandatory vaccinations under the National Immunisation Programme, as well as vaccines and other immunological medicinal products constituting a reserve, used in the event of an epidemic threat or epidemic, was included. 7. In accordance with Art. 97(3)(3d) of the Act on health care services financed from public funds, the scope of the Funds 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 implemented in accordance with the requirements specified in the SWZ and in the Draft Contract Provisions. 9. Means of proof: Pursuant to Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the contract or the award criteria or requirements related to the implementation of the contract, the Contracting Authority requires Contractors to submit the following documents: • A marketing authorisation for the medicinal product valid on the date of submission of tenders, 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 date of submission of tenders, issued by the Council of the European Union or the European Commission. 9.1. In accordance with Art. 107(1) of the Pzp Act, the Contractor is obliged to submit the above-mentioned means of proof 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 them for correctness. 9.2. The marketing authorisation for the medicinal product must be valid and current on the date of submission of tenders. 9.3. The composition of the preparation and packaging must be consistent with the content of the documents referred to in point 9. 9.4. In the event that the validity of a document expires, the Contractor is obliged to provide the Contracting Authority, together with the documents referred to in point 9, with an additional document declaring the submission in due time of an application for extension of the validity of the marketing authorisation for the medicinal product or, in the event of its granting, a valid marketing authorisation for the medicinal product. 9.5. The Contractor is obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the marketing authorisation holder arising from the marketing authorisation for the medicinal product. 9.6. The above documents must have a validity period covering the entire contract implementation period. 9.7. The documents referred to above are submitted in the manner provided for in regulations issued on the basis of Art. 70 of the Pzp Act. 9.8. In accordance with Art. 107(2) of the Pzp Act, the Contracting Authority provides for the possibility of a one-time supplementation of the above means of proof within a deadline set by the Contracting Authority. 9.9. Means of proof prepared in a foreign language are submitted together with a translation into Polish. There is no obligation to translate into Polish proper names, commonly used technical terminology, trademarks, trade names, and indications of the origin of goods.
1. The subject of the contract is the supply of hepatitis B vaccine for children, inj. 0.5 ml, on the terms specified in the content of the SWZ. 2. Total quantity (purchase volume): 80,000 doses. 3. When selecting the most advantageous tender, the Contracting Authority reserves the right to reduce the purchase of the medicinal product, however by no more than 20% of each part of the above subject of the contract, in the event of exceeding the amount allocated for the implementation of the contract or the emergence of objective and justified needs, in particular a change in demand among patients. 4. Based on Art. 256 of the Pzp Act, the Contracting Authority may cancel the contract award procedure accordingly before the expiry of the deadline for submission of tenders, if circumstances arise making further conduct of the procedure unjustified. 5. In accordance with Art. 257 of the Pzp Act, the Contracting Authority may cancel the contract award procedure if the public funds which the Contracting Authority intended to allocate to finance the whole 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 2270), in the Act of 27 August 2004 on health care services financed from public funds (Journal of Laws of 2025, item 1461), the financing by the National Health Fund of the acquisition of vaccines used for mandatory vaccinations under the National Immunisation Programme, as well as vaccines and other immunological medicinal products constituting a reserve, used in the event of an epidemic threat or epidemic, was included. 7. In accordance with Art. 97(3)(3d) of the Act on health care services financed from public funds, the scope of the Funds 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 implemented in accordance with the requirements specified in the SWZ and in the Draft Contract Provisions. 9. Means of proof: Pursuant to Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the contract or the award criteria or requirements related to the implementation of the contract, the Contracting Authority requires Contractors to submit the following documents: • A marketing authorisation for the medicinal product valid on the date of submission of tenders, 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 date of submission of tenders, issued by the Council of the European Union or the European Commission. 9.1. In accordance with Art. 107(1) of the Pzp Act, the Contractor is obliged to submit the above-mentioned means of proof 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 them for correctness. 9.2. The marketing authorisation for the medicinal product must be valid and current on the date of submission of tenders. 9.3. The composition of the preparation and packaging must be consistent with the content of the documents referred to in point 9. 9.4. In the event that the validity of a document expires, the Contractor is obliged to provide the Contracting Authority, together with the documents referred to in point 9, with an additional document declaring the submission in due time of an application for extension of the validity of the marketing authorisation for the medicinal product or, in the event of its granting, a valid marketing authorisation for the medicinal product. 9.5. The Contractor is obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the marketing authorisation holder arising from the marketing authorisation for the medicinal product. 9.6. The above documents must have a validity period covering the entire contract implementation period. 9.7. The documents referred to above are submitted in the manner provided for in regulations issued on the basis of Art. 70 of the Pzp Act. 9.8. In accordance with Art. 107(2) of the Pzp Act, the Contracting Authority provides for the possibility of a one-time supplementation of the above means of proof within a deadline set by the Contracting Authority. 9.9. Means of proof prepared in a foreign language are submitted together with a translation into Polish. There is no obligation to translate into Polish proper names, commonly used technical terminology, trademarks, trade names, and indications of the origin of goods.