Vaccines - Hepatitis A Vaccine For Adults 2.. In The Framework Of A Purchase Contract, The Tenderer Acquires An Inactivated, Adsorbed Vaccine Against Hepatitis A For Adults. Atc Code: J07bc02 Total Quantity: 5000 Doses + 2500 Dose Option Packaging: 1 X 1-Dose Syringe Or Ampoule, If The Recommended Product Is Ampoule-Packaged, 2 Needles And 1 Syringe Of The Type Recommended By The Vaccine Must Be Included Quality Requirement: The Vaccine Must Comply With Who Trs 858, Requirements For Hepatitis A Vaccine (Inactivated); And The Requirements Of Monograph 01/2019:1107 Of The European Pharmacopoeia. Usable: The Vaccine Must Be Usable For At Least 16 Months From The Date Of Storage. In Case Of Advance Payment, Regardless Of The Date Of Advance Payment, The Vaccine Must Be Usable For 16 Months From The Storage Deadline Specified In The Contract. Storage Deadline: Within 15 Days From The Conclusion Of The Contract. Delivery Means The Delivery Of The Entire Amount Of The Vaccine Due At The Given Storage Date To The Place Of Delivery, And Storage Means Making The Entire Amount Of The Vaccine Due At The Given Storage Date Available To The Contracting Authority In A Marketable Manner. Marketing Authorization: The Vaccine Must Have The Recommended 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 Council, Regulation 1901/2006/Ec Of The European Parliament And Council Or Regulation 1394/2007/Ec Of The European Parliament And Council. With A Valid Marketing Authorization For The Vaccine. 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.
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