Fully closed systems for handling hazardous medicines

A bidder may be excluded for final convictions within the past five years, or an exclusion period still in force, involving participation in a criminal organisation, corruption, fraud, terrorist offences, money laundering or terrorist financing, child labour or human trafficking. The grounds also cover failure to pay taxes or social security contributions; bankruptcy, insolvency, liquidation, creditor arrangements, court or liquidator administration, or suspended business activity; serious professional misconduct; anti-competitive agreements; conflicts of interest that cannot be otherwise resolved; involvement in preparing the procurement where an resulting competitive advantage cannot be remedied; and serious or repeated breaches of previous contracts resulting in early termination, damages or comparable sanctions. Exclusion may also follow from breaches of environmental, social or labour obligations, submitting false or misleading information, withholding required information or documents, or improperly obtaining confidential information or influencing the procurement decision. National grounds include enabling unlawful employment of a foreign national, being subject to an international or Estonian government sanction, and conviction for tax offences. The notice sets the tax and social-contribution debt threshold at EUR 0; its explanatory note states that an Estonian tax-debt certificate is not issued for debt below EUR 100 or where payment has been deferred. Where permitted, a bidder may provide evidence of measures taken to restore its reliability.

No specific financial capacity, experience or personnel qualification thresholds are stated in the available documents. The tender documents set the following offer and product requirements: - By submitting a bid, the bidder confirms acceptance of all tender-document conditions; conditional bids are not permitted. The bidder must provide details of the person authorised to sign the contract, including proof of authority where applicable, and the contract contact person’s name, telephone number and email address. - Prices must follow the structure in the designated pricing form. The bidder must complete and submit Annex I, the technical description and bid form, and provide manufacturer-issued technical information sufficient to verify the characteristics and compliance of the offered products. - All products must bear the CE marking and comply with Medical Device Regulation (EU) 2017/745. Manufacturer-issued documents confirming compliance must be submitted. Evidence must also establish that the products are safe and are fully closed systems (Closed System Transfer Devices, CSTD). - Where an equivalent product, standard or other referenced solution is offered, the bidder must explain and substantiate its equivalence. - The bidder must identify any information claimed as a trade secret and give reasons; bid prices and other specified evaluation-related figures may not be designated as trade secrets. - The bidder must confirm that the goods are not subject to international sanctions and do not originate from sanctioned regions. It must also confirm that it will not involve, for more than 10% of the contract value, subcontractors or suppliers who are Russian nationals, residents or established in Russia, entities more than 50% directly or indirectly owned by such persons or entities, or persons or entities acting on their behalf or under their direction.