Poland – Cardiac valve – Dostawa zastawek serca dla potrzeb Uniwersyteckiego Centrum Kardiologii i Kardiochirurgii

1) are not excluded on the basis of Article 108(1) and Article 109(1)(4) of the Public Procurement Law (Pzp)

2) meet the participation requirements in the following areas:

a) economic and financial standing - The Contracting Authority does not specify any particular conditions for participation in the procedure in this regard.

b) technical or professional ability - The Contracting Authority does not specify any particular conditions for participation in the procedure in this regard.

3) are not excluded on the basis of Article 7(1) of the Act of 13 April 2022 on special solutions to counter the support of aggression against Ukraine and serving to protect national security (Journal of Laws of 2025, item 514)

4) their offer is not excluded on the basis of Article 1 of the Commission Implementing Regulation (EU) 2025/1197 of 19 June 2025 imposing a measure of the International Procurement Instrument limiting the access of contractors and medical products originating in the People's Republic of China to the EU public procurement market for medical products in accordance with Regulation (EU) 2022/1031 of the European Parliament and of the Council

5) are not subject to the prohibition referred to in Article 5k 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 of 31 July 2014, p. 1, as amended)

Information on the IPI mechanism:

1. Pursuant to Article 2(2)(a) of the Commission Implementing Regulation (EU) 2025/1197, the origin of the Contractor is determined in accordance with the criteria set out in Article 3 of Regulation (EU) 2022/1031 of the European Parliament and of the Council, while the origin of the medical product is determined in accordance with Article 60 of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code.

2. Pursuant to Article 3 of Regulation (EU) 2022/1031, the place of origin of the Contractor is:

1) in the case of a natural person – the state of which that person is a national or in which that person has a place of permanent residence;

2) in the case of a legal person:

a) the state in accordance with the law of which the legal person was established or otherwise organised and on whose territory it carries out substantial economic activity;

b) if the legal person does not carry out substantial economic activity on the territory of the state in which it was established or otherwise organised, the place of origin of that legal person is the place of origin of the person or persons who can exercise, directly or indirectly, a dominant influence on that legal person by virtue of owning that legal person, holding a financial interest in it or the rules governing that legal person.

3. For the purposes of point 2(b) above, it is deemed that a given person or persons exercise a dominant influence on a given legal person in any of the following cases, directly or indirectly:

1) they hold the majority of the subscribed capital of the legal person;

2) they control the majority of the votes attached to the shares or securities issued by the legal person; or

3) they can appoint more than half of the members of the administrative, management or supervisory body of the legal person.

4. In the case where the Contractor is a group of natural or legal persons, public entities or any combination thereof, and at least one of those persons or at least one of those entities originates from the People's Republic of China, whose contractors, goods or services originate from the People's Republic of China, that group of Contractors is excluded from the procedure. However, in the case where the share of such persons or entities in the group is less than 15 % of the value of the bid submitted by that group, the exclusion of the Contractor(s) shall not apply, unless those persons or entities are essential to meet at least one of the qualification criteria (if the condition for participation in the procedure is specified) in the given public procurement procedure.

5. The Contracting Authority may at any time during the procedure for the award of the contract call upon the Contractor to submit, extend, explain or supplement (within a specified time limit) information or documents related to the verification of the origin of the Contractor (while respecting the principle of equal treatment and transparency).

6. In the case where the Contractor, without justified explanation, does not provide the information or documents referred to in point 5, thereby preventing the Contracting Authority from verifying the origin of the Contractor or making such verification practically impossible or very difficult, the Contractor shall be excluded from participation in the procedure.

7. Pursuant to Article 60 of Regulation (EU) No 952/2013:

- goods wholly obtained in one country or on one territory are deemed to originate in that country or territory;

- goods whose production covers more than one country or more than one territory are deemed to originate in the country or territory in which they underwent the last substantial, economically justified processing or working in an undertaking equipped for that purpose, which led to the creation of a new product or represented a substantial stage in the manufacture of the product.

The prohibition also covers subcontractors, suppliers and entities on whose capabilities the contractor relies, in cases where more than 10 % of the contract value falls to them.