Recomb. hepatitis B vaccine - 13 years old

The contracting authority procures recombinant hepatitis B vaccine under a purchase agreement, for vaccinations due at 13 years of age (according to a 2 or 3 dose schedule). Vaccine name: Recombinant hepatitis B vaccine for vaccinations due at 13 years of age (according to a 2 or 3 dose schedule) ATC code: J07BC01 Total quantity: According to 2-dose schedule 475,000 doses + 23,750 doses option According to 3-dose schedule 712,500 doses + 35,625 doses option The contracting authority, pursuant to Section 6 (1) of Government Decree 16/2012 (II.16.), mandates the obligation to provide a price discount as referred to in Section 2, point 1 of Government Decree 16/2012 (II.16.) for at least 20% of the total quantity (base quantity + optional quantity). The offered discount quantity is to be delivered in addition to the total quantity (base quantity and optional quantity) specified in the procurement. The offered discount quantity must be provided in proportion to the offered discount for each delivery, within the base and optional quantities. If the contracting authority only partially utilizes the optional quantity, the discount must still be provided from the utilized optional quantity in the offered proportion. Based on the above, the discount rate depends on the vaccine offered by the tenderer: at least 20% of 498,750 doses in the case of a 2-dose schedule, or at least 20% of 748,125 doses in the case of a 3-dose schedule. Packaging: 1 x 1 dose syringe. If the offered product is in ampoule packaging, 2 needles and 1 syringe of a type recommended by WHO, compatible with the vaccine, must be included. Quality requirement: The vaccine must meet the requirements of WHO TRS 978: Recommendations to Assure the Quality, Safety and Efficacy of Recombinant Hepatitis B Vaccines; and the European Pharmacopoeia 07/2025:1056 monograph. Usability: The vaccine must be usable for at least 18 months from the date of storage. Storage deadline: For vaccine according to 2-dose schedule: August 1, 2026: 91,700 doses December 15, 2026: 87,500 doses July 1, 2027: 87,500 doses December 1, 2027: 83,300 doses July 1, 2028: 70,800 doses December 1, 2028: 54,200 doses For vaccine according to 3-dose schedule: August 1, 2026: 87,500 doses September 1, 2026: 87,500 doses December 15, 2026: 87,500 doses July 1, 2027: 87,500 doses September 1, 2027: 87,500 doses December 1, 2027: 87,500 doses July 1, 2028: 70,800 doses September 1, 2028: 62,500 doses December 1, 2028: 54,200 doses Marketing authorization: At the time of submitting the offer, the vaccine must have a valid marketing authorization issued by the pharmaceutical authority (NNGYK, or previously OGYÉI / GYEMSZI / OGYI) or by the EC 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. Wholesale pharmaceutical license: At the time of submitting the offer, the tenderer must possess a valid wholesale pharmaceutical license according to Decree 53/2004 (VI.2.) EszCsM or Act XCV of 2005, covering the product group of the subject of the procurement. Packaging: The offered 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 detailed rules concerning the security features of the external packaging of medicinal products for human use. The contracting authority accepts foreign language packaging, but a Hungarian patient information leaflet is required. Delivery means the delivery of the total quantity of the vaccine due at a given storage date to the place of performance, and storage means making the total quantity of the vaccine due at a given storage date available to the contracting authority in a marketable form...