Compliance requirements
The bidder must confirm that the company, its management or supervisory board members, procurist and authorised representatives are not subject to exclusion grounds. The checks cover, among other matters, convictions for participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering or terrorist financing, and the use of child labour or human trafficking. Compliance with tax and social security payment obligations, environmental, social and labour law obligations is also checked, as are bankruptcy or other insolvency situations, arrangements with creditors, assets administered by a liquidator or court, suspended business activity, serious professional misconduct, anti-competitive agreements, conflicts of interest, involvement in preparing the procurement, material breaches of previous contracts, and the submission of false information or failure to provide required documents. The bidder must also confirm that entering into the contract would not breach international or national sanctions and that the offered goods are not subject to sanctions or sourced from a sanctioned region. Subcontractors or suppliers covered by the relevant Russian sanctions may not account for more than 10% of the contract value. The bidder’s specific declarations and any supporting evidence must be provided in the European Single Procurement Document; where applicable, evidence of remedial measures may also be submitted.
Qualification criteria and exclusion grounds
The bidder must hold a valid wholesale distribution licence issued by the Estonian State Agency of Medicines, covering the handling and distribution of the medicines covered by the contract, including narcotic and psychotropic medicines. The bidder must provide a reference to the relevant register entry in the European Single Procurement Document or, if this is not possible, a copy of the licence.
The bidder must also hold a valid medicinal product manufacturing licence issued by the Estonian State Agency of Medicines. The licence must cover the site used for contract performance and the manufacturing operations specified in section 4.5 of the technical description, including adding required information leaflets and other materials to or with medicinal product packaging. A register reference or a copy of the licence must be provided.
In addition, the bidder must hold a certificate demonstrating compliance with European Union Good Distribution Practice requirements. A register reference or a copy of the certificate must be provided.
A responsible person with pharmacist training must be involved in contract performance. The bidder must submit evidence of the person’s pharmacist education and a signed confirmation from that person stating that they will participate in performing the contract.
The tender must include the completed price form (Annex 3). The tender must comply with all tender documents, and conditional tenders are not permitted. In a joint tender, a power of attorney from the joint tenderers must be included. The bidder must identify and justify any trade secrets; the tender price and numerical figures used for evaluation may not be classified as trade secrets.