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Tender Result Brief :
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Contract awarded for Hpv vaccine
lot-0001, title: "hpv vaccine", description: the contracting authority has initiated a negotiated public procurement procedure in accordance with the eu procedure, under section 85 (1) c) of the public procurement act, for the procurement of a 9-component hpv vaccine according to a 2-dose scheme, due for vaccination at the age of 12 (recombinant, adsorbed). atc code: j07bm total quantity: 237,500 doses + 190,000 doses option. the contracting authority stipulates, based on section 6 (1) of government decree 16/2012 (ii.16.), the obligation to provide a discount on goods corresponding to at least 20% of the total quantity (base quantity + optional quantity) as per section 2 (1) of government decree 16/2012 (ii.16.). the offered discount quantity must be supplied in addition to the total quantity specified in the procurement (base quantity and optional quantity). the offered discount quantity must be ensured in accordance with the ratio of the offered discount during each storage occasion in the base and optional quantities. if the contracting authority only partially utilizes the optional quantity, the discount must still be provided in the offered ratio from the utilized optional quantity. the contracting authority determined the quantity of the optional part in accordance with section 6 (2) of government decree 16/2012 (ii.16.). the seller may deviate by 2% from the quantity specified for each storage deadline, considering the manufacturing batches of the vaccine, with the condition that the total quantity must be stored by the expiration of the sales contract. in case of a quantity deviation not reaching 2%, the consequences specified in this sales contract shall not apply. packaging: the packaging offered by the supplier. if the offered 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 offered product is in ampoule packaging, a syringe and two needles of the type recommended by who necessary for administration must be attached. if the seller can supply a vaccine in a different packaging of 10x, the seller is obliged to inform the buyer in writing before delivery, and the buyer is entitled to accept a packaging different from the one offered. quality requirement: the vaccine must comply with who trs 999: recommendations to assure the quality, safety and efficacy of recombinant human papiloma virus-like particle vaccines; the european pharmacopoeia 01/2019:2441 monograph. usability: the vaccine must be usable for at least 20 months from the date of storage. at the request of the seller, the buyer is entitled to authorize the delivery of a vaccine with a shorter usability period in a separate written statement, provided that the seller guarantees unconditional and immediate replacement for the unused quantity. the usability period of the replaced vaccine shall be determined in writing by the parties in each case. storage deadlines: september 1, 2026: 58,300 doses + the offered discount (minimum 20%) february 1, 2027: 75,000 doses + the offered discount (minimum 20%) february 1, 2028: 50,000 doses + the offered discount (minimum 20%) september 1, 2028: 45,900 + the offered discount (minimum 20%) december 1, 2028: 8,300 + the offered discount (minimum 20%) 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 regulation (ec) no 726/2004 of the european parliament and of the council, regulation (ec) no 1901/2006 of the european parliament and of the council, or regulation (ec) no 1394/2007 of the european parliament and of the council at the time of submission of the offer. wholesale drug distribution license: the bidder must have a valid wholesale drug distribution license covering the product group of the subject of the procurement according to decree 53/2004 (vi.2.) eszcsm and act xciv of 2005 at the time of submission of the offer. packaging: the offered 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.
estimated value excluding vat: 9240840000.00 huf.Hpv vaccine
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