Poland - Medicinal products for the blood and blood-forming organs

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Details

Provided by Open Opps
Opportunity closing date
04 October 2021
Opportunity publication date
22 September 2021
Category
33621000: Me
Value of contract
to be confirmed
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Description

The subject matter of the order includes the supply of clotting factor IX concentrate under the implementation of:Part 1 of the NFZ Drug Program entitled "Prevention of bleeding in children with hemophilia A and B" in children previously treated with plasma-derived factors aged 9-18 years, as well as the supply of infusion sets for vascular ports for a specified number of patients, organization of home deliveries for a specified number of patients, disposal of disposable equipment and control of drug consumption.Part 2 of the Health Policy Program of the Minister of Health entitled "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019-2023" The Ordering Party requires the Contractor to offer the same type of coagulation factor IX concentrate for both parts of the contract.
I. 1.1 The offered subject of the contract must have a valid decision, i.e. be covered by reimbursement on the date of submitting the offer1.2 The basic purchase for the years 2021-2023 includes the supply of coagulation factor for the treatment of 23 patients included in the programme with the total weight of 1469 kg1.3 The number of patients may change +/- 8 persons, the total weight of the patients may increase to 1950 kg1.4 The number of patients with inserted ports: 7, subject to change in number of patients: +/- 2II. SUBJECTIVE EVIDENCE:2.1 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 with the evaluation criteria for the tenders or the requirements connected with the performance of the contract, the Contracting Authority demands from the Economic Operators to present the following documents:-Permit for marketing of 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-Permit for marketing of the medicinal product issued by the Council of the European Union or the European Commission2.1.1. The marketing authorisation for the medicinal product must be valid and up-to-date as of the date on which tenders are submitted2.1.2. The composition of the preparation and packaging must be consistent with the content of the documents referred to in 2.1.2.1.3. The aforementioned documents must have a validity period covering the entire period of performance of the contract2.1.4. If a document expires, the Contractor shall submit to the Contracting Authority, together with the documents referred to in item 2.1, an additional document declaring that an application for renewal of the marketing authorisation for the medicinal product has been submitted in due time or, if granted, a valid marketing authorisation for the medicinal product.2.1.5 Pursuant to Article 107(2) of the PPL Act. Further, pursuant to art. 105 and art. 106 of the PPL Act the Ordering Party shall have the right to supplement the above mentioned means of evidence once within the time limit set by the Ordering Party.2.2. In addition, pursuant to art. 105 and 106 of the PPL Act, in order to confirm compliance of the offered supplies 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:-Characteristic of Medicinal Product (ChPL)and/or-Copies of scientific publications/clinical evidence published in the list of scientific journals and peer-reviewed materials from international conferences specified in the Announcement of the Minister of Education and Science of 9 February 2021 (in case the ChPL does not confirm the dosage method/declared dose)which will enable the Ordering Party to verify the elements of the total cost of 28-day treatment of 1 kg of the patient's body weight under the NFZ programme, constituting criterion no. 1 of the offer evaluation in part 1, i.e.N - number of doses of coagulation factor in one weekDkg - dose of international units of the product per 1 kg of the patient's body mass2.2.1. 2 letter c. 2.2.2. The Contracting Authority, pursuant to art. 107 item 3 of the PPL Act Pursuant to Article 107(1) of the PPL Act, the Contractor shall submit the above-mentioned means of evidence together with the tender and shall take all necessary care to ensure that the said documents are complete and contain all information necessary to enable the Contracting Authority to verify their correctness.2.3 Documents shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act.2.4 Documents prepared in a foreign language shall be submitted with a translation into Polish I. The subject matter of the order covers the supply of coagulation factor IX concentrate - hereinafter referred to as "coagulation factor" as part of the implementation of the Ministry of Health's health policy programme entitled "National Programme for the Treatment of Haemophilia and Related Haemorrhagic Sicknesses for the years 2019-2023", hereinafter referred to as "MHP programme". - hereinafter referred to as the "MZ program", as well as the supply of infusion sets for vascular ports for a certain number of patients.1.2. The total volume of the basic purchase for the years 2021-2023 in the minimum (guaranteed) quantity is 800,000 IU.II. SUBJECTIVE EVIDENCE:2.1 Pursuant to Article 105 and Article 106 of the PPL Act. .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 criteria for evaluation of tenders or requirements connected with performance of the contract, the Contracting Authority demands from the Economic Operators to present the following documents:- Valid marketing authorization for a 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-Valid marketing authorization for a medicinal product issued by the Council of the European Union or the European Commission.2.2 The marketing authorisation for the medicinal product must be valid and up to date at the date of submission of the tender.2.3 The composition of the preparation and packaging must be consistent with the content of the documents referred to in paragraph 2.2.2.4 In the event that the document validity expires, the Contractor shall submit to the Contracting Authority, together with the documents referred to in paragraph 2.2, an additional document declaring the timely submission of an application for the extension of medicinal product marketing authorisation or, if granted, a valid medicinal product marketing authorisation.2.5 The aforementioned documents must have a validity period covering the entire period of contract performance. 2.6. Pursuant to provisions of Article 107, item 1 of the PPL Act the Contractor shall submit the above mentioned evidence together with the tender and shall make every effort to ensure that the said documents are complete and contain all the necessary information to enable the Contracting Authority to verify their correctness.2.7. 2.7. Pursuant to Article 107(2) of the PPL Act the Contracting Authority shall allow the above mentioned means of evidence to be supplemented once within the time limit specified by the Contracting Authority.2.8. The documents referred to above shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act.2.9.

Opportunity closing date
04 October 2021
Value of contract
to be confirmed

About the buyer

Address
ZAKŁAD ZAMÓWIEŃ PUBLICZNYCH przy MINISTRZE ZDROWIA Al. Jerozolimskie 155, pok. 115 Warszawa 02-326 Poland
Contact
b.kowalski@zzpprzymz.pl

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