Poland – Medical consumables – Dostawa jałowego sprzętu jednorazowego użytku do Apteki

The subject of the order is: Supply of sterile, single-use equipment to the Hospital Pharmacy. 2. The order has been divided into 5 packages. 3. The detailed description of the order subject contains a price form constituting Annex 1A to SWZ. VIII LIST OF SUBJECT MATTER EVIDENTIAL MEANS 1. The ordering party, in order to confirm the conformity of the offered supplies, requires the submission with the offer of the following subject matter evidential means: 1) Declaration of Conformity* – a document issued by the manufacturer of the product or its authorized representative. (applies to all classes of medical devices) 2) Certificate of Conformity* – a document issued by a notified body in the field of medical devices, certifying the conduct of conformity assessment procedures. (applies to medical devices classified in classes: I sterile, I with measuring function, II A, IIb, III and in accordance with EU Directive 98/79, devices in classes A and B) 3) Manufacturer's catalog cards and/or other manufacturer's materials* confirming all the parameters required in the description of the order subject, containing catalog numbers and photographs/drawings of the offered assortment. The ordering party allows the possibility of submitting with the offer catalog cards issued by the direct importer/distributor of the manufacturer in Poland *The ordering party requires that at least one of the above-mentioned documents confirms the conformity of the assortment with the standards contained in the description of the order subject in the price form. 2. Subject matter evidential means drawn up in a foreign language are to be submitted together with a translation into Polish. 3. The ordering party requires that the subject matter evidential means be drawn up in electronic form and endorsed with a qualified signature by the Contractor. 4. In the event that the subject matter evidential means have been drawn up in electronic form and endorsed with a qualified signature by their issuer (authorized entity), they should be submitted in such a form. 5. In the event that the subject matter evidential means have been issued in paper form, a digital copy of the document endorsed with a qualified signature by the contractor shall be submitted 6. In the event that the Contractor does not submit with the offer the subject matter evidential means or the submitted subject matter evidential means are incomplete, the ordering party will call for their submission or completion within a specified deadline. 7. The ordering party requires that the subject matter evidential means confirm the actual state as of the date of submission of the offers. 8. The ordering party requires that the subject matter evidential means be up-to-date as of the date of submission/completion. 1. List of declarations submitted with the offer: 1) Declaration of the absence of grounds for exclusion from the procedure, drawn up in the form of the European Single Procurement Document (ESPD) - according to the template constituting Annex 2 to SWZ. The ordering party informs that the Contractor, when completing the declaration on the ESPD form, may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes a preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of the offers. b) The declaration is submitted by each of the contractors jointly applying for the award of the contract. The declaration must demonstrate the absence of grounds for exclusion of each of the contractors. 2) The ordering party informs that the Contractor may use the document (ESPD) submitted in a separate procurement procedure, if it confirms that the information contained therein remains valid. 3) The Contractor, when completing the ESPD form: a) Part I (Information on the procurement procedure and the ordering institution or ordering entity) - fills it in obligatorily, b) Part II (Information on the contractor) - fills it in obligatorily, to the extent relevant to the requirements specified by the ordering party in the subject matter procedure, NOTE: The contractor places information about the certificate in Part II, Section A, in the field concerning the entry in the official register of approved contractors or the possession of an equivalent certificate. The contractor should provide data enabling:  identification of the certificate;  determination of the certifying entity;  finding the certificate in the database;  determination of the scope in which the contractor intends to use it. c) in the scope of Part III (Grounds for exclusion) the contractor fills in the fields indicated by the ordering party on the ESPD form, d) Part IV (Qualification criteria) the contractor does not fill in, e) Part V of the ESPD form - the contractor does not fill in, f) Part VI (Final declarations) the contractor fills in obligatorily. 4) Declaration that the contractor is not subject to exclusion under Article 7(1) of the Penal Code and Article 5k of the EU Regulation – the content of the declaration contained in the offer form (Annex 1 to SWZ) 5) The absence of grounds for exclusion may be demonstrated: a) by subject matter evidential means indicated in VII 2.1 SWZ or b) by a valid certificate of the contractor, if the content of the certificate confirms the absence of grounds for exclusion from the procedure in the scope required by the ordering party, and the data contained in the ESPD submitted with the offer and the offer enable the ordering party to identify the certificate and obtain it independently. XII DESCRIPTION OF THE METHOD OF PREPARING THE OFFER 1. The contractor is obliged to submit on the date of submission of the offers: a) Offer form using the template constituting Annex 1 to SWZ b) Price form using the template constituting Annex 1A to SWZ. c) Contractor's Declaration (ESPD) - according to the template constituting Annex 2 to SWZ. d) Declaration of the absence of grounds for exclusion in the scope of the Penal Code – the content of the declaration contained in the offer form. e) Subject matter evidential means, as referred to in Section VIII SWZ f) Power of attorney (if applicable) NOTE!!! Annexes 1 and 1A to SWZ constitute the content of the offer and, consequently, are not subject to supplementation. The absence of these documents constitutes the invalidity of the submitted offer