Poland - Medicinal products for blood and blood-forming organs

Description

The subject of the order is the supply of activated prothrombin syndrome factor concentrate (aPCC) in accordance with the description of the subject of the order specified in the SWZ and under the conditions specified in the Draft Provisions of the Agreement (PPU), which constitute an annex to the SWZ.The purchase is carried out under the health policy program of the Minister of Health entitled "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for the years 2019-2023".
I. DETERMINATION OF THE SUBJECT OF THE ORDER:1. The subject of the order is the supply of activated prothrombin complex factor concentrate (aPCC)2. Total number (purchase volume): 11,000,000 IU.3. Dosage proportions: as specified in the SWZ.4. The coagulation factor must be supplied with a kit enabling its administration or a vascular port infusion kit.5. In accordance with Article 257 of the PPL Act. The Contracting Authority may invalidate the award procedure if the public funds that the Contracting Authority intended to allocate to finance the whole or part of the contract have not been awarded to him.6. The Contracting Authority reserves the right to reduce the purchase of the medicinal product, however not more than by 20% of the total subject matter of the contract, in case the amount allocated for the contract is exceeded or objective and justified needs arise, particularly changes in patient demand.7.The order shall be executed in compliance with the requirements of the description of the subject matter of the contract laid down in the Terms of Reference (SWZ) and on the terms and conditions set forth in the Draft Provisions of the Contract (PPU), which constitute an annex to the SWZ.II. SUBJECT MATERIALS:1. Pursuant to art. 105 and art. 106 of the PPL Act, in order to confirm compliance of the offered supplies with the requirements of the tender specification, the Contracting Authority shall provide the following 1. Pursuant to Article 105 and Article 106 of the PPL Act, in order to confirm compliance of the supplies offered with the requirements, features or criteria specified in the description of the subject matter of the contract or evaluation criteria, or requirements related to contract performance, the Contracting Authority demands from the Economic Operator to present the following documents:- A valid marketing authorization for the medicinal product in the territory of the Republic of Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,or- A valid marketing authorization for the medicinal product issued by the Council of the European Union or the European Commission.2Pursuant to Article 107(1) of the PPL Act, the Contractor shall submit the above mentioned evidence together with the tender and shall take all necessary care to ensure that the documents are complete and contain all information necessary to enable the Contracting Authority to verify their accuracy.3 The marketing authorization for the medicinal product must be valid and up-to-date as of the date on which the tender is submitted.4 The composition of the preparation and the packaging must be the same as that of the product.If the document validity expires, the Contractor shall submit to the Contracting Authority, together with the documents referred to in item 1, an additional document declaring that an application for renewal of the marketing authorization for the medicinal product has been submitted in due time or, if granted, a valid marketing authorization for the medicinal product.6.The Contractor shall be obliged to inform the Contracting Authority about the transfer of rights and obligations of the responsible entity resulting from the marketing authorization for the medicinal product to another entity.7.The aforementioned documents must have a validity period covering the entire period of performance of the contract.8. The documents referred to above shall be submitted in the manner provided for in the regulations issued pursuant to Article 70 of the PPL Act, i.e. in the Regulation of the Prime Minister of 30 December 2020 on the manner of preparing and submitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or in competition.9. The Contracting Authority shall allow for the possibility to supplement the abovementioned means of evidence once within the time limit indicated by the Contracting Authority.10. Documents prepared in a foreign language shall be submitted together with a translation into Polish.

Opportunity closing date

06 July 2022

Value of contract

to be confirmed