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

OBJECT OF THE CONTRACT

1. The subject of the contract is: DELIVERY 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 parts: Parts No. 1 – 4 – PROGRAMME DRUGS, Parts No. 5 – 38 BASIC DRUGS, Parts No. 39 – 48 ANTIBIOTICS, Parts No. 49 – 50 PHARMACEUTICAL RAW MATERIALS, Part No. 51 – CONTRAST MEDIA, Part No. 52 – STERILE GEL, Part No. 53 – DISINFECTION OF CATHETER, Part No. 54 – SPECIALIST BANDAGES, Part No. 55 – MEDICAL DEVICES, Parts No. 56 – 68 – PSYCHOTROPIC DRUGS, Parts No. 69 – 75 – ANAESTHETIC DRUGS, Part No. 76 – DRY CONCENTRATE FOR HEMODIALYSIS. 2. The detailed scope of the contract has been specified in Appendix No. 2 to SWZ – assortment price form. Other conditions relating to the implementation of the contract have been specified in the draft contract terms (PPU) - Appendix No. 6 to SWZ. 3. All the requirements specified in the documents indicated above constitute minimum requirements, and their fulfilment is obligatory. Failure to meet the above minimum requirements will result in the rejection of the offer as non-compliant with the contract conditions on the basis of Article 226(1)(5) of the PZP Act. 4. The Contracting Authority allows the submission of partial offers. By the term partial offer is meant individual parts determined in Appendix No. 2 to SWZ. The Contractor may submit an offer for any parts or for the whole subject of the contract. 5. The Contracting Authority agrees to the offer of alternative preparations, i.e.: tablets / coated tablets / dragees / capsules / hard capsules / soft capsules; vials / ampoules / ampoule-syringes / injectors; flacons / bottles. 6. The Contracting Authority agrees to a change in the size of the packaging of liquids, syrups, ointments, creams with the conversion 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 Part in case of discontinuation of production or withdrawal of the subject of the contract from the market and to include a note - discontinuation of production / withdrawal of the product, provided that the offer is accompanied by appropriate documents confirming this fact. 8. The Contracting Authority agrees to the valuation of products available on a one-off permit 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. catalogue cards / descriptions / folders / photographs / producer information / leaflets / brochures / user instructions / Contractor's declaration* - confirming the fulfilment of all the parameters required by the Contracting Authority described in Appendix No. 2 to SWZ (assortment price form) - concerning Parts 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 (catalogue cards / descriptions / folders / photographs / producer information / leaflets / brochures). 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 may 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 Appendix No. 9 to SWZ. All the required current documents, including product characteristic cards, will be submitted within the specified time limit upon each request of the Contracting Authority, during the period of the concluded contract - concerning the offered products qualified as pharmaceutical products; c) a declaration of 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 Appendix No. 9 to SWZ. All the required current documents, including characteristic cards, will be submitted within the specified time limit upon each request of the Contracting Authority, during the period of the concluded contract - concerning the offered products qualified as medical devices. 2. If the Contractor has not submitted the subject evidence or the submitted subject evidence is incomplete, the Contracting Authority will call for their submission or completion within the specified time limit (Article 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 features or criteria specified in the description of the offer assessment criteria or, despite the submission of the subject evidence, the offer is subject to rejection or the conditions for the invalidation of the procedure occur. 4. The Contracting Authority may require Contractors to explain the content of the subject evidence (Article 107(4) PZP). 5. In the course of the examination and evaluation of offers, the Contracting Authority may require Contractors to explain the content of the submitted offers and subject evidence or other documents or declarations submitted (Article 223(1) first sentence 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.