Poland – Pharmaceutical products – DOSTAWA PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH ORAZ SUCHEGO KONCENTRATU DO HEMODIALIZY DLA WOJEWÓDZKIEGO SZPITALA SPECJALISTYCZNEGO IM. NAJŚWIĘTSZEJ MARYI PANNY W CZĘSTOCHOWIE

SUBJECT OF THE CONTRACT 1. The subject of the contract is: SUPPLY OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND DRY CONCENTRATE FOR DIALYSIS for the Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny in Częstochowa. The subject of the contract includes 76 items: Items No. 1 – 4 – PROGRAMME DRUGS, Items No. 5 – 38 BASIC DRUGS, Items No. 39 – 48 ANTIBIOTICS, Items No. 49 – 50 PHARMACEUTICAL RAW MATERIALS, Item No. 51 – CONTRASTS, Item No. 52 – STERILE GEL LUBRICANT, Item No. 53 – CATHETER DISINFECTION, Item No. 54 – SPECIALIST BANDAGES, Item No. 55 – MEDICAL DEVICES, Items No. 56 – 68 – PSYCHOTROPIC DRUGS, Items No. 69 – 75 – ANESTHETIC DRUGS, Item No. 76 – DRY CONCENTRATE FOR HEMODIALYSIS. 2. The detailed scope of the contract has been specified in Annex No. 2 to SWZ – assortment-price form. Other conditions related to the implementation of the contract have been specified in the draft contract terms (PPU) - Annex No. 6 to SWZ. 3. All the requirements specified in the documents indicated above are minimum requirements, and their fulfillment is mandatory. Failure to meet the above minimum requirements will result in the rejection of the offer as non-compliant with the contract conditions pursuant to art. 226.1.5 of the PZP Act. 4. The Contracting Authority allows the submission of partial offers. Partial offer means individual items specified in Annex No. 2 to SWZ. The Contractor may submit an offer for any items or for the entire subject of the contract. 5. The Contracting Authority agrees to the offer of alternative preparations, i.e.: tablets / coated tablets / lozenges / capsules / hard capsules / soft capsules; vials / ampoules / ampoule-syringes / injectors; flacons / bottles. 6. The Contracting Authority agrees to the change in the size of the packaging of liquids, syrups, ointments, creams with the recalculation of the packaging based on the appropriate unit of measurement, i.e. mg/ml. 7. The Contracting Authority allows the Contractor to delete the subject of the contract from a given Item in the event of the end of production or withdrawal of the subject of the contract from the market and to include a note - end of production/withdrawal of the product, provided that the offer includes appropriate documents confirming this fact. 8. The Contracting Authority agrees to the pricing of products available on a one-off license from the Minister of Health, in the event that only such products are currently available on the market. INFORMATION ON SUBJECT EVIDENCE 1. In order to confirm the compliance of the offered supplies with the requirements specified in the description of the subject of the contract related to the implementation of the contract, the Contracting Authority requires the submission of subject evidence with the offer: a) descriptions of the subject of the contract, i.e. catalog cards / descriptions / folders / photographs / manufacturer's information / leaflets / prospectuses / instructions for use / Contractor's declaration* - confirming the fulfillment of all the parameters required by the Contracting Authority described in Annex No. 2 to SWZ (assortment-price form) - applies to Items No. 52-54, 76. *The Contractor's declaration applies only in the case of lack of confirmation of the parameters required by the Contracting Authority in the documents (catalog cards / descriptions / folders / photographs / manufacturer's information / leaflets / prospectuses). Documents or declarations drawn up in a foreign language are submitted together with a translation into Polish; b) a declaration by the Contractor that the offered assortment has all the current documents required by Polish law, on the basis of which it can be introduced into circulation and used in healthcare facilities in the territory of the Republic of Poland, in accordance with the Act of 6 September 2001 on Pharmaceutical Law (Journal of Laws of 2026, item 612 with later amendments) and other applicable legal provisions in the scope of the offered subject of the contract – in accordance with the template contained in Annex No. 9 to SWZ. All the required current documents, including product characteristic cards, will be submitted upon each request of the Contracting Authority, within the period of the concluded contract – applies to offered products qualified as pharmaceutical products; c) a declaration of the conformity of the offered product qualified as a medical device with the Act of 7 April 2022 on Medical Devices (Journal of Laws of 2024, item 1620) – in accordance with the template contained in Annex No. 9 to SWZ. All the required current documents, including characteristic cards, will be submitted upon each request of the Contracting Authority, within the period of the concluded contract – applies to offered products qualified as medical devices. 2. If the Contractor has not submitted subject evidence or the submitted subject evidence is incomplete, the Contracting Authority will call for their submission or completion within the specified deadline (art. 107.2 PZP). 3. The Contracting Authority informs that, despite the provision of a call, it will not call for the submission or completion of subject evidence if the subject evidence serves to confirm compliance with the characteristics or criteria specified in the description of the criteria for evaluating offers or, despite the submission of the subject evidence, the offer is subject to rejection or the conditions for invalidating the procedure occur. 4. The Contracting Authority may request explanations from the Contractors regarding the content of the subject evidence (art. 107.4 PZP). 5. During the examination and evaluation of the offers, the Contracting Authority may request explanations from the Contractors regarding the content of the submitted offers and the subject evidence or other documents or declarations submitted (art. 223.1.1 PZP). 6. The Contracting Authority will accept equivalent subject evidence if they confirm that the offered supplies meet the requirements specified by the Contracting Authority. 7. Subject evidence, subject evidence and other documents or declarations, drawn up in a foreign language, are submitted together with a translation into Polish.