DTPa-IPV-Hib (5-component) vaccine

The contracting authority is procuring DTPa-IPV-Hib (5-component) vaccine containing diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae b antigens with acellular pertussis component, through a purchase agreement, for vaccinations due at 2, 3, 4, and 18 months of age. Vaccine name: Diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae b vaccine with acellular pertussis component for vaccinations due at 2, 3, 4, and 18 months of age ATC code: J07CA06 Total quantity: 660,000 doses + 66,000 doses option Packaging: As offered by the supplier. If the offered product is a pre-filled syringe but without a needle, then 2 needles of a type recommended by WHO, compatible with the vaccine, must be included. If the offered product is in an ampoule, then a syringe of a type recommended by WHO, compatible with the vaccine, and 2 needles must be included. Quality requirement: The vaccine must meet the requirements of 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 897: Recommendations for the production and control of Haemophilus influanzae type b conjugate 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; and the European Pharmacopoeia 07/2025:2065 monograph. Usability: The vaccine must be usable for at least 18 months from storage. Storage deadline: December 1, 2026. 50,000 doses; February 1, 2027. 90,000 doses; May 2, 2027. 85,000 doses; August 1, 2027. 65,000 doses; December 1, 2027. 80,000 doses; February 1, 2028. 75,000 doses; May 2, 2028. 70,000 doses; August 1, 2028. 70,000 doses; December 1, 2028. 75,000 doses. The seller may deviate by a maximum of 2% from the quantities specified for each storage deadline. This provision does not apply to the last installment of the optional quantity, and the total quantity of the vaccine may not change. Marketing authorization: At the time of submitting the offer, the vaccine must have a valid marketing authorization for the offered vaccine, 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. 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 detailed rules concerning the security features of the outer 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. Storage means making the total quantity of the vaccine due at a given storage date available to the contracting authority in a marketable form.