Poland - Medicinal products for blood and blood-forming organs

Description

The subject matter of the order covers the supply of the active substance emicizumab together with administration sets (hereinafter referred to as the "medicinal product") within the framework of the Health Policy Programme of the Minister of Health entitled. "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019-2023", hereinafter referred to as the "MZ Program", as well as the organization of home delivery for the indicated number of patients, disposal of disposable equipment, control of the use of medicines development, preparation of information materials on the safe use of medicinal products for all patients and training of patients and/or their legal guardians on the safe use of the medicinal product.
I.1 The subject of the contract is, within the implementation of the MZ program, the purchase of the active substance emicizumab with sets allowing its administration with supplies to the Hemophilia and Related Hemorrhagic Ailments Treatment Centers, under the care of which the patients are included, and directly to the patients' homes, in accordance with the description of the subject of the contract determined in the Terms of Reference (ToR) and under the conditions specified in the Draft Provisions of the Contract (ToC), which constitute an annex to the ToR.2The total volume of the basic purchase for 2022-2023 is 210,000 mg for the treatment of approximately 55 patients.3. The Contractor shall train all patients in the safe use of the medicinal product no later than the date of the first delivery and provide medical waste containers for all patients, meeting the requirements of the applicable regulations, and collect and dispose of medical waste.4. Pursuant to Article 257 (1) 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 were not awarded to him.II.1. 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 with the evaluation criteria for the tenders or requirements connected with performance of the contract, the Contracting Authority demands from the Economic Operators to submit the following documents:- A valid, as of the date of submitting the tender, 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, as of the date of submitting the tender, 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 Economic Operator is obliged to submit the above-mentioned means of 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.3The marketing authorization for the medicinal product must be valid and up-to-date as of the date of placing bids.4 The composition of the preparation and the packaging must comply with the content of the documents referred to in item 1.5 If the validity of the document 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.6The Contractor shall be obliged to inform the Contracting Authority if the rights and obligations of the responsible entity arising from the marketing authorization for a medicinal product are transferred to another entity.7 The aforementioned documents shall be valid for the entire period of contract performance. 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. pursuant to Article 107(2) of the PPL Act 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

30 May 2022

Value of contract

to be confirmed