Poland – Medical gases – DOSTARCZANIE GAZÓW MEDYCZNYCH I GAZÓW TECHNICZNYCH WRAZ Z NAJMEM ORAZ NAPEŁNIANIEM BUTLI I ZBIORNIKÓW

The subject of the contract is the supply of medical and technical gases, including rental and filling of cylinders and containers to the Contracting Authority (Kraków, os. Złotej Jesieni 1 / Maków Podhalański, ul. Mickiewicza 7) in accordance with the description and requirements set out in Annex 1A to this Specification. 2. The validity period / warranty period of the subject of the contract: shall not be less than 12 months from the date of delivery, with the exception of liquid medical oxygen. 3. By medicinal product, which is the subject of the contract, shall be understood medicinal products within the meaning of the Pharmaceutical Law of 6 September 2001. The offered medicinal product must be authorised for marketing in accordance with the provisions of art. 3 or 4 para. 1 and 2 or 4a of the Pharmaceutical Law. 4. By medical devices, which are the subject of the contract, shall be understood medical devices within the meaning of the Act of 7 April 2022 on medical devices. The offered medical devices must be authorised for marketing and use in accordance with the provisions of the Act on medical devices. 5. By technical gases, which are the subject of the contract, shall be understood technical gases within the meaning of the law and must have certificates or certificates allowing for marketing and use. 6. The quantities of gases given are estimated quantities, calculated on the basis of consumption over the last 24 months and serve to calculate the price of the offer (i.e. to determine the maximum remuneration of the Contractor). 7. The Contracting Authority reserves the right to waive the purchase of part of the assortment due to lack of demand. 8. The Contracting Authority recommends that the Contractor carry out a preliminary local inspection of the delivery sites and their immediate surroundings, in order to obtain information that may be necessary to prepare the offer for the conclusion of the contract and the execution of the order. The costs of the local inspection shall be borne by the Contractor. Express interest in participation by e-mail: [email protected]. REQUIRED TERMS AND CONDITIONS OF CONTRACT PERFORMANCE 1. The deliveries of the subject of the contract shall be made successively, within 24 months from the date of conclusion of the contract, according to the written orders placed by the employee of the Hospital Pharmacy/Infrastructure Department of the Hospital. 2. The contract performance period - no longer than 2 working days from the date of the order. 3. The possibility of deliveries in an urgent mode in the shortest time agreed with the Head of the Hospital Pharmacy/Head of the Hospital Infrastructure Department, but not longer than 24 hours from the date of the telephone order, confirmed by fax/e-mail. 4. In the case of filling the Contracting Authority's own cylinders, the delivery time is up to 10 working days. CONDITIONS OF PARTICIPATION IN THE PROCEDURE AND THE WAY OF EVALUATING THE FULFILMENT OF THESE CONDITIONS 1. The order may be granted to Contractors who meet the conditions specified in art. 57 of the Pzp and art. 112 para. 2 of the Pzp, i.e.: are not excluded and meet the conditions of participation in the procedure, concerning: authorisations to carry out a specific economic or professional activity. The order may be sought by Contractors who prove that they have a licence to trade in medicinal products. The Contracting Authority will assess the fulfilment of this condition of participation in the procedure on the basis of the documents submitted by the Contractor, as referred to in Section IX para. 1 lit. b) of the Specification. 2. In the Procedure, Contractors who are not excluded from the procedure on the basis of art. 108 of the Pzp and art. 109 para. 1 point 1 and point 4 of the Pzp and are not excluded from the procedure on the basis of art. 7 para. 1 of the Act of 13 April 2022 on special solutions in the field of counteracting the support for aggression on Ukraine and serving the protection of national security (Dz.U. z 2022 poz. 835), and are not prohibited from awarding or further executing any public contracts on the basis of Article 5k para. 1 of Council Regulation (EU) No 833/2014 of 31 July 2014 concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine (OJ L 229, 31.07.2014, p. 1, as amended). The Contracting Authority, in accordance with art. 139 para. 1 of the Pzp, informs that it will first carry out an examination and evaluation of the offers, and then carry out a substantive qualification of the contractor, whose offer has been the highest, in the scope of the lack of grounds for exclusion and the fulfilment of the conditions of participation in the procedure. SUBSTANTIVE EVIDENCE 1. The Contracting Authority requires the submission of the following with the offer – if applicable: a) certificate of authorisation for marketing for medicinal products – authorisation for marketing in accordance with art. 3 para. 1 of the Pharmaceutical Law; b) certificate of authorisation for marketing for medical gases – confirmation of registration of the medical gas as a medicinal product in accordance with the applicable regulations, i.e.: 1) the Act of 6 September 2001 on Pharmaceutical Law (i.e. Dz. U. z 2026 r. poz. 612 z późn. zm.), 2) the Act of 7 April 2022 on medical devices (i.e. Dz. U. z 2024 r. poz. 1620 z późn. zm.), 3) the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (i.e. Dz. U. z 2023 r. poz. 1223 z późn. zm.); c) certificate of authorisation for marketing for technical gases – certificates or certificates allowing for marketing and use; d) certificate of authorisation for marketing for medical devices: 1) manufacturer's declaration of conformity, 2) CE conformity certificate (if applicable), 3) notification or notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a certificate from the President of URPL on the fulfilment of the information obligation, 4) in the case of registration of the product on the basis of art. 138 para. 7 of the Act of 7 April 2022 on medical devices, confirmation of registration of the product in the EUDAMED database