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Tender Result Brief :
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Contract awarded for Dtpa-ipv (4-component) vaccine
lot-0001, title: "dtpa-ipv (4-component) vaccine", description: the contracting authority has initiated a negotiated public procurement procedure in accordance with the eu procedure, section 85 (1) c) of the public procurement act, under which it will procure a dtpa-ipv (4-component) vaccine containing components against diphtheria, tetanus, whooping cough, and epidemic poliomyelitis, due for a booster vaccination at the age of 6. vaccine name: dtpa-ipv (4-component) vaccine containing components against diphtheria, tetanus, whooping cough, and epidemic poliomyelitis for the booster vaccination due at the age of 6 atc code: j07ca02 total quantity: 250,000 doses + 25,000 doses option packaging: the packaging proposed by the supplier. if the proposed product is a pre-filled syringe but in a needle-free packaging, two needles of the type recommended by who must be attached to the vaccine. if the proposed product is in ampoule packaging, a syringe and two needles of the type recommended by who necessary for administration must be attached. quality requirement: the vaccine must comply with: • who trs 980: recommendations to assure the quality, safety and efficacy of dt-based combined vaccines; • who trs 979: recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines; • who trs 1016: guidelines for safe production and quality control of poliomyelitis vaccines; • who trs 1028: guidelines for safe production and quality control of poliomyelitis vaccines; • european pharmacopoeia 07/2022:1934 monograph requirements. usability: the vaccine must be usable for at least 18 months from the date of delivery. storage deadlines: within 15 days from the contract signing: 24,500 doses by november 15, 2026: 45,500 doses by february 1, 2027: 25,000 doses by may 2, 2027: 25,000 doses by august 1, 2027: 25,000 doses by december 1, 2027: 20,000 doses by february 1, 2028: 25,000 doses by may 2, 2028: 20,000 doses by august 1, 2028: 20,000 doses by december 1, 2028. the seller may deviate from the quantities specified in the individual storage deadlines by a maximum of 2%. this provision does not apply to the last installment of the optional quantity, and the total quantity of the vaccine cannot change. marketing authorization: the vaccine must have a valid marketing authorization issued by the pharmaceutical authority (nngyk, or previously ogyéi /gyemszi/ ogyi) or by the european commission under the european parliament and council regulation 726/2004, the european parliament and council regulation 1901/2006, or the european parliament and council regulation 1394/2007, applicable to the proposed vaccine at the time of the bid submission. wholesale drug distribution license: the applicant (bidder) must have a valid wholesale drug distribution license covering the product group of the subject of the public procurement according to the 53/2004 (vi.2.) eszcsm regulation and the 2005 xcvi act at the time of bid submission. packaging: the proposed vaccine must comply with the detailed rules regarding safety features to be placed on the outer packaging of medicinal products for human use as specified in the commission delegated regulation (eu) 2016/161 of october 2, 2015, supplementing directive 2001/83/ec of the european parliament and of the council. the contracting authority accepts foreign language packaging, but a hungarian language patient information leaflet is required. during delivery, the complete quantity due at the specified storage date must be delivered to the place of performance, and during storage, the complete quantity due at the specified storage date must be made available to the contracting authority in a marketable manner. the atc code, the basic quantity of the vaccine, and the extent of the option, the quality requirements, as well as the existence of the marketing authorization and the wholesale drug distribution license are minimum requirements that the contracting authority will not negotiate according to section 87 (1) of the public procurement act. the contracting authority will negotiate the usability period of the vaccine, the storage deadlines, the quantity of the vaccine due at each storage date, and the packaging of the vaccine, and these will be finalized during the negotiation in compliance with the provisions of section 88 (6) of the public procurement act.
estimated value excluding vat: 2145000000.00 huf.Dtpa-ipv (4-component) vaccine
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