Poland – Disposable non-chemical medical consumables and haematological consumables – Supply of stents: Task 1. Stents releasing the drug Rapamycin or derivatives, made of a platinum-chromium alloy

Opportunity description

The subject matter of the contract is: Supply of stents: Task 1. Stents releasing the drug Rapamycin or derivatives, made of a platinum-chromium alloy. The Contracting Authority does not permit the submission of partial tenders. A detailed description of the subject matter of the contract is contained in Annex 2b to the SWZ. 3.3. The Contracting Authority’s requirements concerning the subject matter of the contract: 1) the medical device offered must have approvals and certificates and be registered in accordance with the provisions of law requiring approvals, certificates and registration, 2) the medical device offered must be placed on the market and put into use in accordance with the requirements of the Act of 7 April 2022 on medical devices (Journal of Laws of 2024, item 1620, as amended), 3) the medical device offered must comply with the standards or technical specifications applicable to that device; If the medical device offered does not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor shall be obliged, at its own expense and on its own behalf, to perform all activities necessary to meet all legal requirements related to placing the device on the market and putting it into use within the territory of the Republic of Poland. The Contractor shall perform such activities within the time limits arising from the applicable provisions and provide the Contracting Authority, within those time limits, with the relevant documents confirming that such activities have been performed. 3.4. In cases where the description of the subject matter of the contract indicates trademarks, patents or origin, source or a particular process that characterizes specific products or services supplied by a particular contractor, this means that the Contracting Authority cannot describe the subject matter of the contract in a sufficiently precise and comprehensible manner; however, in each such situation, the Contracting Authority permits a solution equivalent to those described above. In such situations, any references to trademarks, patents, origin, source or a particular process that characterizes specific products or services supplied by a particular contractor shall be read together with the words “or equivalent.” When describing the subject matter of the contract by reference to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101(1)(2) and (3), the Contracting Authority permits solutions equivalent to those described. In such situations, any references shall be read together with the words “or equivalent.” 3.5. The Contracting Authority requires the subject matter of the contract to be performed under the terms specified in the agreement. The draft provisions of the public procurement agreement that will be incorporated into the agreement constitute annexes to the SWZ. Origin of goods. 1) The Contractor undertakes that goods supplied in the performance of the agreement will not originate, in more than 50% of the total contract value, from the People’s Republic of China (PRC), if the contract is subject to an IPI measure pursuant to Regulation (EU) 2025/1197 of 19.06.2025 (hereinafter referred to as Regulation 2025/1197) and Article 8(1)(b) of Regulation (EU) 2022/1031 of the European Parliament and of the Council of 23 June 2022 on the access of third-country economic operators, goods and services to the Union’s public procurement and concession markets and procedures supporting negotiations on access of Union economic operators, goods and services to the public procurement and concession markets of third countries (International Procurement Instrument – IPI), hereinafter referred to as Regulation 2022/1031. 2) The Contractor undertakes not to subcontract a portion exceeding 50% of the total value of the agreement to entities originating from the PRC (Article 8(1)(a) of Regulation 2022/1031). INFORMATION ON ENVISAGED CONTRACTS REFERRED TO IN ARTICLE 214(1)(7) AND (8), IF THE CONTRACTING AUTHORITY ENVISAGES AWARDING SUCH CONTRACTS. The Contracting Authority does not envisage awarding contracts referred to in Article 214(1)(7) of the Pzp Act. The Contracting Authority does not envisage awarding contracts referred to in Article 214(1)(8) of the Pzp Act. DESCRIPTION OF THE CRITERIA THAT THE CONTRACTING AUTHORITY WILL APPLY WHEN SELECTING THE TENDER, INCLUDING THE WEIGHTINGS OF THOSE CRITERIA AND THE METHOD OF EVALUATING TENDERS. 13.1. Tenders will be evaluated on the basis of the criteria specified in the SWZ and their weightings. Tenders will be scored separately in relation to the individual Tasks. During the evaluation of tenders, the tenders considered and evaluated in turn will be awarded points for the following criteria according to the following rules: PRICE CRITERION weighting: 60% CRITERION: TIME LIMIT FOR PERFORMANCE OF A PARTIAL ORDER weighting: 40% Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.