Tenders Are Invited For Vaccines - Dtpa-Ipv (4-Component) Vaccine in Hungary

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Vaccines - Dtpa-Ipv (4-Component) Vaccine. Name Of Vaccine: Dtpa-Ipv (4-Component) Vaccine Against Diphtheria, Tetanus, Whooping Cough And Polio, Containing Acellular Pertussis Component For Booster Vaccination For Vaccination Due At Age 6 Atc Code: J07ca02 Total Quantity: 250,000 Doses + 25,000 Dose Option Packaging: Packaging Recommended By The Supplier. If The Recommended Product Is A Pre-Filled Syringe 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. Quality Requirement: The Vaccine Must Comply With: • Who Trs 980: Recommendations To Assure The Quality, Safety And Efficacy Of Dt-Based Combined Vaccines; • Who Trs 979: Recommendations To Ensure The Quality, Safety And Efficacy Of Acellular Pertussis 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; • European Pharmacopoeia 07/2022:1934 Monograph Requirements. Usability: The Vaccine Must Be Usable For At Least 18 Months From Delivery. Storage Deadline: Within 15 Days Of Signing The Contract Or June 15 (Whichever Comes First): 15,000 Portions September 1, 2026: 30,000 Portions December 1, 2026: 25,000 Portions February 1, 2027: 25,000 Portions May 2, 2027: 25,000 Portions 2027 1 August 25,000 Doses 1 December 2027 20,000 Doses 1 February 2028: 25,000 Doses 2 May 2028: 20,000 Doses 1 August 2028: 20,000 Doses 1 December 2028: 20,000 Doses Marketing Authorization: At The Time Of Submission Of The Offer, The Vaccine Must Have A Valid Marketing Authorization Issued By The Pharmaceutical Authority (Nngyk, Or Ogyéi /Gyemszi/ Ogyi At The Time) Or By The Ec On The Basis Of Regulation 726/2004/Ec Of The European Parliament And Of The Council, Regulation Of The European Parliament And Of The Council Of 1901/2006/Ec Or Regulation Of The European Parliament And Of The Council Of 1394/2007/Ec For The Proposed Vaccine With A Production Permit. Pharmaceutical Wholesale License: When Submitting The Offer, The Applicant (Bidder) Must Have The 53/2004 (Vi.2.) Eszcsm Decree, 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. The Vaccine Is Stored During Transport

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