Diagnostic kits for newborn cystic fibrosis screening

The bidder must confirm that the company, its administrative, management or supervisory body members, procurists and other persons authorised to represent or control it have not been convicted by a final court decision within the last five years of participation in a criminal organisation, corruption, fraud, terrorism, money laundering or terrorist financing, child labour or human trafficking offences. There must also be no continuing exclusion obligation. The bidder must not have breached its tax or social security payment obligations, be bankrupt or in liquidation, be subject to insolvency proceedings, or be in another comparable situation. Grounds for exclusion may also include assets being administered by a liquidator or court, suspended business activities, serious professional misconduct, agreements restricting competition, a conflict of interest, serious breach or early termination of previous public contracts, submission of false information, failure to provide required information, or improper influence on the contracting authority’s decision-making process. Compliance with environmental, social and labour-law obligations will also be considered, together with national exclusion grounds concerning employment of unlawfully staying foreign nationals, international sanctions and convictions for tax offences. Where an exclusion ground applies, the bidder may, where permitted in the procurement, provide evidence of remedial measures demonstrating its reliability. The bidder must provide the required declarations in the European Single Procurement Document and submit relevant evidence upon request by the contracting authority.

The bidder’s total net turnover over the last three financial years completed by the time of publication of the contract notice must be at least EUR 96,000 excluding VAT. Turnover information must be provided in the European Single Procurement Document, and supporting documents must be submitted upon request by the contracting authority. The bidder must employ or otherwise have contractually available a product representative for the offered products who has been trained by the manufacturer or its authorised representative in the offered products or equivalent products of the same manufacturer. The product representative’s name and a confirmation of the training must be provided in the European Single Procurement Document; copies of training certificates must be submitted upon request. The tender must comply with the technical specification. The bidder must submit the technical specification form in Annex 1 and the price form in Annex 2 with all required information. The total price must be stated in euros excluding VAT for three years and must include all costs related to delivery and unloading at the Tartu University Hospital Clinic of Genetics and Personalised Medicine, L. Puusepa 2, Tartu. The submitted prices are final and no additional costs may be added. The offered diagnostic kits must comply with Regulation (EU) 2017/746 or be placed on the market under its transitional provisions. Declarations of conformity and, where applicable, certificates of conformity issued by a notified body must be submitted. Where the transitional provisions apply, the bidder must also submit a declaration of conformity with Directive 98/79/EC and a manufacturer’s confirmation that compliance with Regulation (EU) 2017/746 will be ensured by the end of the transitional period. Where a joint tender is submitted, a power of attorney for the joint tenderers must be included in accordance with Form I, and all bidders must submit the participation application using Form II.