Varicella vaccine

The contracting authority procures Varicella vaccine according to a 2-dose schedule for individuals under 2 years of age through a purchase agreement. Vaccine name: Varicella vaccine for individuals under 2 years of age, according to a 2-dose schedule ATC code: J07BK01 Total quantity: 360,000 doses + 36,000 doses option; The Seller may deviate by 2% from the quantities specified for each storage deadline, taking into account the production batches of the vaccine, provided that the total quantity must be stored by the expiry of the purchase agreement. In case of a quantity deviation not reaching 2%, the consequences specified in this purchase agreement shall not apply. Packaging: 1 x 1-dose syringe. If the offered product is in ampoule packaging, 2 needles and 1 syringe of a WHO-recommended type compatible with the vaccine must be included. If the Seller can supply the vaccine in a per-dose packaging different from the offered one, but with fewer than 20 doses per package, the Seller is obliged to inform the Buyer in writing before delivery, and the Buyer is entitled to accept the packaging different from the offered one. If the Seller can supply the vaccine in a per-dose packaging different from the offered one, but with 20 or more doses per package, the Seller is obliged to obtain the Buyer's prior written consent before delivery, and the Buyer is entitled to accept the packaging different from the offered one. Quality requirement: The vaccine must meet the requirements of WHO TRS 848: Requirements for Varicella Vaccine (Live); and the European Pharmacopoeia monograph 01/2019:0648. Usability: The vaccine must be usable for at least 16 months from the date of delivery. Upon the Seller's request, the Buyer may, by separate written declaration, authorize the delivery of vaccine with a shorter usability period than prescribed, provided that the Seller undertakes unconditional and immediate exchange guarantee for the unused quantity. The usability period of the vaccine exchanged in this way shall be determined individually in writing by the Parties in each case. Storage deadlines: September 1, 2026: 15,000 doses December 10, 2026: 40,000 doses February 1, 2027: 80,000 doses August 1, 2027: 75,000 doses February 1, 2028: 45,000 doses May 2, 2028: 35,000 doses August 1, 2028: 35,000 doses December 1, 2028: 35,000 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, Regulation (EC) No 1901/2006, or Regulation (EC) No 1394/2007 for the offered vaccine. 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 public 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 the detailed rules for the safety features on 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 vaccine due at a given storage date to the place of performance, and storage means making the total quantity of vaccine due at a given storage date available to the contracting authority in a marketable form.