Poland – Medical gases – SUPPLY OF MEDICAL GASES AND TECHNICAL GASES, INCLUDING THE RENTAL AND FILLING OF CYLINDERS AND TANKS

Opportunity description

1. The subject matter of the contract is the supply of medical gases and technical gases, including the rental and filling of cylinders and tanks, to the Contracting Authority (Kraków, os. Złotej Jesieni 1 / Maków Podhalański, ul. Mickiewicza 7), in accordance with the description and requirements contained in Annex No 1A to these Specifications. 2. Shelf life / warranty period for the subject matter of the contract: it may not be shorter than 12 months from the date of delivery, excluding liquid medical oxygen. 3. A medicinal product constituting the subject matter of the contract shall mean medicinal products within the meaning of the Pharmaceutical Law Act of 6 September 2001. The medicinal product offered must be authorised for marketing in accordance with the rules specified in Article 3 or Article 4(1) and (2), or Article 4a, of the Pharmaceutical Law Act. 4. Medical devices constituting the subject matter of the contract shall mean medical devices within the meaning of the Act of 7 April 2022 on medical devices. The medical devices offered must be authorised for marketing and use in accordance with the rules specified in the Act on medical devices. 5. Technical gases constituting the subject matter of the contract shall mean technical gases within the meaning of the provisions of law and must have approvals or certificates authorising their marketing and use. 6. The specified quantities of gases are estimated quantities, calculated on the basis of consumption during the last 24 months, and are used to calculate the tender price (i.e. to determine the Contractor’s maximum remuneration). 7. The Contracting Authority reserves the right to refrain from purchasing part of the assortment due to a lack of demand. 8. The Contracting Authority recommends that the Contractor conduct a preliminary site visit to the delivery locations and their immediate surroundings in order to obtain information that may be necessary to prepare a tender for the purpose of concluding the contract and performing the order. The costs of the site visit shall be borne by the Contractor. Requests to participate should be sent by email to: jsitek@rydygierkrakow.pl. REQUIRED TIME LIMIT AND CONDITIONS FOR PERFORMANCE OF THE CONTRACT 1. Deliveries of the subject matter of the contract will be made successively over 24 months from the date of conclusion of the contract, in accordance with written orders placed by an employee of the Hospital Pharmacy/Hospital Infrastructure Department. 2. Order completion time – no longer than 2 working days from the date the order is placed. 3. The possibility of urgent deliveries within the shortest possible time agreed with the Head of the Hospital Pharmacy/Head of the Hospital Infrastructure Department, but no later than within 24 hours from the date the order is placed by telephone and confirmed by fax/email. 4. If cylinders owned by the Contracting Authority are filled, the delivery time shall be up to 10 working days. CONDITIONS FOR PARTICIPATION IN THE PROCEDURE AND THE METHOD OF ASSESSING COMPLIANCE WITH THOSE CONDITIONS 1. Contractors that meet the conditions specified in Article 57 of the Pzp Act and Article 112(2) of the Pzp Act may participate in the award procedure, i.e.: they are not subject to exclusion and meet the conditions for participation in the procedure concerning: authorisation to conduct a specific business or professional activity. Contractors that demonstrate that they hold an authorisation to trade in medicinal products may apply for the award of the contract. The Contracting Authority will assess compliance with this condition for participation in the procedure on the basis of the documents submitted by the Contractor, referred to in Chapter IX(1)(b) of the Specifications. 2. Contractors that are not subject to exclusion from the procedure pursuant to Article 108 of the Pzp Act and Article 109(1)(1) and (4) of the Pzp Act, and are not subject to exclusion from the procedure pursuant to Article 7(1) of the Act of 13 April 2022 on special measures to counteract support for aggression against Ukraine and to protect national security (Journal of Laws of 2022, item 835), and are not subject to the prohibition on the award or continued performance of any public contracts pursuant to Article 5k(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 EU L 229, 31.07.2014, p. 1, as amended), may participate in the Procedure. Pursuant to Article 139(1) of the Pzp Act, the Contracting Authority states that it will first examine and evaluate the tenders and will then perform the qualitative selection of the contractor whose tender received the highest evaluation with regard to the absence of grounds for exclusion and compliance with the conditions for participation in the procedure. SUBJECT-MATTER EVIDENCE 1. The Contracting Authority requires the following to be submitted with the tender, where applicable: a) marketing authorisation for medicinal products – marketing authorisation pursuant to Article 3(1) of the Pharmaceutical Law Act; b) marketing authorisation for medical gases – confirmation of the registration of the medical gas as a medicinal product in accordance with the applicable provisions, i.e.: 1) the Pharmaceutical Law Act of 6 September 2001 (consolidated text: Journal of Laws of 2026, item 612, as amended), 2) the Act of 7 April 2022 on medical devices (consolidated text: Journal of Laws of 2024, item 1620, as amended), 3) the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (consolidated text: Journal of Laws of 2023, item 1223, as amended); c) marketing authorisation for technical gases – approvals or certificates authorising marketing and use; d) marketing authorisation for medical devices: 1) the manufacturer’s declaration of conformity, 2) CE certificate of conformity (if applicable), 3) submission 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 confirming fulfilment of the information obligation, 4) where a device is registered pursuant to Article 138(7) of the Act of 7 April 2022 on medical devices, confirmation of the device’s registration in the EUDAMED database together with the unique registration number issued by URPL, 5) appropriate documents other than those listed above authorising these products for marketing and use. 1. The subject matter of the contract is the supply of medical gases, including the rental and filling of cylinders and tanks, to the Contracting Authority (Kraków, os. Złotej Jesieni 1 / Maków Podhalański, ul. Mickiewicza 7), in accordance with the description and requirements contained in Annex No 1A to these Specifications – concerning Package No 1. 2. Shelf life / warranty period for the subject matter of the contract: it may not be shorter than 12 months from the date of delivery, excluding liquid medical oxygen. 3. A medicinal product constituting the subject matter of the contract shall mean medicinal products within the meaning of the Pharmaceutical Law Act of 6 September 2001 (consolidated text: Journal of Laws of 2022, item 2301, as amended). The medicinal product offered must be authorised for marketing in accordance with the rules specified in Article 3 or Article 4(1) and (2), or Article 4a, of the Pharmaceutical Law Act. 4. Medical devices constituting the subject matter of the contract shall mean medical devices within the meaning of the Act of 7 April 2022 on medical devices (consolidated text: Journal of Laws of 2022, item 974, as amended). The medical devices offered must be authorised for marketing and use in accordance with the rules specified in the Act on medical devices. 5. The specified quantities of gases are estimated quantities, calculated on the basis of consumption during the last 24 months, and are used to calculate the tender price (i.e. to determine the Contractor’s maximum remuneration). 6. The Contracting Authority reserves the right to refrain from purchasing part of the assortment due to a lack of demand. 7. The Contracting Authority recommends that the Contractor conduct a preliminary site visit to the delivery locations and their immediate surroundings in order to obtain information that may be necessary to prepare a tender for the purpose of concluding the contract and performing the order. The costs of the site visit shall be borne by the Contractor. Please provide advance notice of the intention to participate in the site visit by email to: jsitek@rydygierkrakow.pl. 1. The subject matter of the contract is the supply of technical gases, including the rental and filling of cylinders, to the Contracting Authority (Kraków, os. Złotej Jesieni 1 / Maków Podhalański, ul. Mickiewicza 7), in accordance with the description and requirements contained in Annex No 1A to these Specifications – concerning Package No 2. 2. Technical gases constituting the subject matter of the contract shall mean technical gases within the meaning of the provisions of law and must have approvals or certificates authorising their marketing and use. 3. The specified quantities of gases are estimated quantities, calculated on the basis of consumption during the last 24 months, and are used to calculate the tender price (i.e. to determine the Contractor’s maximum remuneration). 4. The Contracting Authority reserves the right to refrain from purchasing part of the assortment due to a lack of demand. 5. The Contracting Authority recommends that the Contractor conduct a preliminary site visit to the delivery locations and their immediate surroundings in order to obtain information that may be necessary to prepare a tender for the purpose of concluding the contract and performing the order. The costs of the site visit shall be borne by the Contractor. Please provide advance notice of the intention to participate in the site visit by email to: jsitek@rydygierkrakow.pl. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.