HPV elleni oltóanyag HPV elleni oltóanyag

HPV elleni oltóanyag HPV elleni oltóanyag
Request for tenders in the EU procedure, Kbt. It started a negotiated public procurement procedure according to Section 85 (1) point c), within the framework of which it acquires a 9-component, 2-vaccination scheme against HPV for vaccinations due at the age of 12 (recombinant, adsorbed). ATC code: J07BM Total quantity: 237,500 doses + 190,000 doses option. 16/2012. (II.16.) Government Decree 16/2012, based on § 6 (1) (II.16.) The obligation to give a discount on goods in accordance with Section 2.1. of the Government Decree at a minimum of 20% of the total quantity (basic quantity + option quantity). The quantity offered for the discount must be delivered in addition to the total quantity (basic quantity and optional quantity) listed in the public procurement. The amount of the offered discount must be provided in accordance with the offered ratio of the discount in the basic and optional quantities for each storage. If the contracting authority uses only part of the option quantity, the discount from the used option quantity must be provided in this case as well. The tenderer determined the amount 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, in view of the production batches of the Extinguishing Material, by requiring that the entire quantity be stored until the expiration of the sales contract. In the case of a quantity difference of less than 2%, the consequences specified in this sales contract do not apply. Packaging: Packaging recommended by the supplier. If the product offered is a pre-filled syringe, but is packaged without a needle, 2 needles of the type recommended by the WHO that match the vaccine must be included. If the recommended product is packaged in an ampoule, a syringe of the type recommended by WHO and 2 needles required for administration must be included. If the Seller can deliver Extinguishing Agent in 10x packs other than the recommended packaging, the Seller is obliged to inform the Buyer in writing prior to the delivery, and the Buyer is entitled to accept a packaging different from the recommended packaging. Quality requirement: The vaccine must comply with WHO TRS 999: Recommendations to assure the Quality, safety and efficacy of recombinant Human Papilloma virus-like particle vaccines; of monograph 01/2019:2441 of the European Pharmacopoeia. Usability: The vaccine must be usable for at least 20 months from the date of storage. At the Sellers request, the Buyer is entitled to authorize the delivery of Fire Extinguisher with a shorter than prescribed shelf life in a separate written statement, if the Seller undertakes an unconditional and immediate replacement guarantee for the unused quantity. The use-by date of the Extinguishing Material exchanged in this way shall be determined individually in writing by the Parties in each case. Delivery deadline: September 1, 2026 58,300 doses + the recommended discount (minimum 20 %) February 1, 2027 75,000 doses + the recommended discount (minimum 20 %) February 1, 2028 50,000 doses + the recommended discount (minimum 20 %) September 1, 2028 45 900 + the recommended amount of discount (minimum 20 %) December 1, 2028 8 300 + the recommended amount of discount (minimum 20 %) Marketing authorization: At the time of submission of the offer, the vaccine must be provided by the pharmaceutical authority (NNGYK, or OGYÉI /GYEMSZI/ OGYI at the time) or by the European Parliament and Council Regulation 726/2004/EC, with a valid marketing authorization for the proposed vaccine issued on the basis of European Parliament and Council Regulation 1901/2006/EC or European Parliament and Council Regulation 1394/2007/EC. Pharmaceutical wholesale license: At the time of submitting the offer, the tenderer must have the EszCsM Decree 53/2004 (VI.2.) and the 2005 XCV. with a valid pharmaceutical wholesale license according to law, covering the product group of the subject of the public procurement. Packaging: The recommended vaccine must comply with Commission Delegated Regulation (EU) 2016/161 of October 2, 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to the definition of detailed rules for safety elements to be placed on the outer packaging of medicinal products intended for human use. The applicant accepts packaging in a foreign language, but a patient information sheet in Hungarian is required. Delivery means the delivery of the entire amount of vaccine due at a given storage date to the place of delivery, and storage means making the entire amount of vaccine due at a given storage date available to the contracting authority in a marketable manner.