Procurement of syringes, needles and skin-disinfection wipes for the National Institute for Health Development

The bidder must confirm that none of the applicable exclusion grounds exists for the company, its management, supervisory or administrative bodies, authorised representatives or other persons able to represent or control it. The grounds include final convictions within the last five years, or a continuing exclusion period, for participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering or terrorist financing, and child labour or other forms of human trafficking. They also include tax or social-security payment debts, subject to the applicable rules; the notice states that a tax-debt certificate is generally not issued where the total debt managed by the same tax authority is below EUR 100 or payment has been deferred. Further grounds concern agreements with creditors, bankruptcy or comparable insolvency proceedings, liquidation or court-appointed administration, suspended business activity, serious professional misconduct, anti-competitive agreements, conflicts of interest, involvement in preparing the procurement, serious or repeated breaches of earlier contracts resulting in early termination, compensation or comparable sanctions, and false or missing information or failure to provide requested documents. National grounds also cover enabling an unlawfully staying foreign national to work, international sanctions, convictions for tax offences and restrictions based on the company’s place of establishment. The bidder must also confirm that the offered goods are not subject to international sanctions and do not originate from sanctioned regions. Where permitted, the bidder may provide evidence of measures taken to restore its reliability.

The machine-readable notice did not specify precise financial, turnover, experience or personnel qualification requirements; these must be checked in the official tender documents. The offer must comply with all procurement documents and may not be conditional. Joint bidders must appoint an authorised representative and submit the relevant authorisation. The price form must follow the prescribed structure, use prices excluding VAT with two decimal places, and include all costs, including transport. The bidder must provide the required product samples: for product groups 1–4, three sterile samples in original primary packaging for each offered product, including different volumes and sizes; for product group 5, one original-packaged sample for each product. Samples must show the product name, manufacturer’s REF number, LOT number, the procurement name and reference number, and the numbering used in the price form. Samples are part of the tender and will not be returned. Offered products must have CE marking and comply with Regulation (EU) 2017/745 or its transitional provisions, except for product group 5 where medical-device requirements do not apply. Copies of the applicable EC certificates or Declarations of Conformity must be submitted, with the offered products clearly identified where documents cover multiple products. If these documents expire during contract performance, updated copies must be provided. For product groups 1–4, the bidder must ensure compliance with the legislation applicable to medical devices and their placing on the market. Equivalence must be explained and supported with evidence where applicable.