Medicinal products for the blood and blood-forming organs (Румыния - Тендер #47726456)

1. Section I
   1. Name and addresses
      Spitalul Clinic Judetean de Urgenta"Sfantul Apostol Andrei"
      Strada: Brăilei, nr. 177
      Galati
      800578
      Romania
      Telephone: +40 236317232
      E-mail: manuela.mihalea@spitalulurgentagalati.ro
      Fax: +40 0236317232
      
   2. Joint procurement
      
   3. Communication
      The procurement documents are available for unrestricted and full direct access, free of charge, at
      https://e-licitatie.ro/pub/notices/c-notice/v2/view/100172476
      Additional information can be obtained from the abovementioned addressto the abovementioned address
      
   4. Type of the contracting authority:
      Other type: Unitate sanitara
      
   5. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         MEDICAMENTE PROGRAM DIALIZA SI PROGRAM HEMOFILIE

         Reference number: 1067762
         
      2. Main CPV code:
         33621000
         
      3. Type of contract:
         Supplies
         
      4. Short description:
         

         MEDICAMENTE PROGRAM DIALIZA SI PROGRAM HEMOFILIE

      5. Estimated total value:
         Value excluding VAT: 8 221 022.40 RON
         
      6. Information about lots:
         maximum number of lots: 7
         Maximum number of lots that may be awarded to one tenderer: 7
         
   2. Description
      1. Title:
         

         epoetinum zeta 10000 ui/1.0ml

         Lot No: 4
         
      2. Additional CPV code(s):
         33621000
         
      3. Place of performance:
         Main site or place of performance:

         STR.BRAILEI NR. 177

      4. Description of the procurement:
         

         CAN. MIN.-50 F

         CANT. MAX.-1200 F

      5. Award criteria:
         
      6. Estimated value:
         Value excluding VAT: 241 716.00 RON
         
      7. Duration of the contract, framework agreement or dynamic purchasing system:
         Duration in months: 24
         This contract is subject to renewal: no
         
      8. Information about the limits on the number of candidates to be invited:
         
      9. Information about variants:
         Variants will be accepted: no
         
      10. Information about options:
          Options: no
      11. Information about electronic catalogues:
          
          
      12. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      13. Additional information:
          
      14. Title:
          

          emicizumabum -hemlibra 150 mg/1 ml

          Lot No: 7
          
      15. Additional CPV code(s):
          33621000
          
      16. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR.177

      17. Description of the procurement:
          

          CANT. MIN.-5 FL

          CANT. MAX. 80 FL

      18. Award criteria:
          
      19. Estimated value:
          Value excluding VAT: 3 076 592.00 RON
          
      20. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      21. Information about the limits on the number of candidates to be invited:
          
      22. Information about variants:
          Variants will be accepted: no
          
      23. Information about options:
          Options: no
      24. Information about electronic catalogues:
          
          
      25. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      26. Additional information:
          
      27. Title:
          

          epoetinum zeta 3000 ui/0.9 ml

          Lot No: 3
          
      28. Additional CPV code(s):
          33621000
          
      29. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR. 177

      30. Description of the procurement:
          

          CANT. MIN.- 50 F

          CANT. MAX.-1200 F

      31. Award criteria:
          
      32. Estimated value:
          Value excluding VAT: 76 860.00 RON
          
      33. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      34. Information about the limits on the number of candidates to be invited:
          
      35. Information about variants:
          Variants will be accepted: no
          
      36. Information about options:
          Options: no
      37. Information about electronic catalogues:
          
          
      38. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      39. Additional information:
          
      40. Title:
          

          emicizumabum -hemlibra 60 mg/0.4 ml

          Lot No: 5
          
      41. Additional CPV code(s):
          33621000
          
      42. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR. 177

      43. Description of the procurement:
          

          CANT. MIN.-10 FL

          CANT. MAX.-160 FL

      44. Award criteria:
          
      45. Estimated value:
          Value excluding VAT: 2 464 150.40 RON
          
      46. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      47. Information about the limits on the number of candidates to be invited:
          
      48. Information about variants:
          Variants will be accepted: no
          
      49. Information about options:
          Options: no
      50. Information about electronic catalogues:
          
          
      51. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      52. Additional information:
          
      53. Title:
          

          epoetinum beta 2000 ui/0.3ml

          Lot No: 1
          
      54. Additional CPV code(s):
          33621000
          
      55. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR. 177

      56. Description of the procurement:
          

          cant. min. 50 f

          cant. max. 1200 f

      57. Award criteria:
          
      58. Estimated value:
          Value excluding VAT: 55 308.00 RON
          
      59. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      60. Information about the limits on the number of candidates to be invited:
          
      61. Information about variants:
          Variants will be accepted: no
          
      62. Information about options:
          Options: no
      63. Information about electronic catalogues:
          
          
      64. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      65. Additional information:
          
      66. Title:
          

          epoetinum beta 5000 ui/0.3 ml

          Lot No: 2
          
      67. Additional CPV code(s):
          33621000
          
      68. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR. 177

      69. Description of the procurement:
          

          CANT. MIN.-50 F

          CANT. MAX. -1200 F

      70. Award criteria:
          
      71. Estimated value:
          Value excluding VAT: 152 064.00 RON
          
      72. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      73. Information about the limits on the number of candidates to be invited:
          
      74. Information about variants:
          Variants will be accepted: no
          
      75. Information about options:
          Options: no
      76. Information about electronic catalogues:
          
          
      77. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      78. Additional information:
          
      79. Title:
          

          emicizumabum -hemlibra 105 mg/0.7 ml

          Lot No: 6
          
      80. Additional CPV code(s):
          33621000
          
      81. Place of performance:
          Main site or place of performance:

          STR. BRAILEI NR. 177

      82. Description of the procurement:
          

          CANT. MIN.- 5FL

          CANT. MAX.-80FL

      83. Award criteria:
          
      84. Estimated value:
          Value excluding VAT: 2 154 332.00 RON
          
      85. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      86. Information about the limits on the number of candidates to be invited:
          
      87. Information about variants:
          Variants will be accepted: no
          
      88. Information about options:
          Options: no
      89. Information about electronic catalogues:
          
          
      90. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      91. Additional information:
          
3. Section III
   1. Conditions for participation:
      1. Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers:
         List and brief description of conditions:

         Cerinta 1

         Declaratie pe proprie raspundere din care sa reiasa ca operatorul economic nu se afla , avand in vedere actiunile sau inactiunile savarsite inainte de initierea procedurii , in una dintre situatiile prevazute la art. 164, art. 165 si art. 167 din Legea privind achizitiile publice nr. 98/23.05.2016.

         Modalitate de demonstrare a indeplinirii cerintei : se va completa DUAE de catre operatorii paticipanti la procedura( ofertanti, terti sustinatori, subcontractanti).

         Documentele justificative care probeaza indeplinirea celor asumate prin completarea DUAE urmeaza a fi prezentate , la solicitarea autoritatii contractante , doar de catre ofertantii clasati pe locul I in clasament in urma finalizarii evaluarii ofertelor.

         Documentele justificative mentionate mai sunt:1 certificate constatatoare privind lipsa datoriilor restante cu privire la plata impozitelor si taxelor sau a contributiilor la bugetul general consolidat(buget local, buget de stat etc.)la momentul prezentarii; In cazul in care operatorul economic are inregistrate , conform Cerificatului constatator emis de ONRC, puncte de lucru in alte circumscriptii teritoriale fiscale , in afara celei in care are declarat sediul social ( ex. comune, municipii, judete), atunci se va prezenta o declaratie de proprie raspundere in acest sens.

         2.cazierul judiciar al operatorului si al membrilor organului de administrare , de conduceresau de supraveghere al respectivului operator economic, sau a celor ce au putere de reprezentare, de decizie sau de control in cadrul acestuia, asa cum rezulta din cerificatul constatator emis de ONRC/ actul constitutiv;

         3.dupa caz, documente prin care se demonstreaza faptul ca operatorul poate beneficia de derogarile prevazute la art. 166 alin.2, art.167 alin. 2, art. 171 din Legea 98/2016 privind achizitiile publice;

         4-alte documente edificatoare, dupa caz.

         Cerinta 2

         Declaratie privind neincadrarea in situatiile prevazute la art.60 alin.1 din Legea 98/2016.

         Persoanele cu functie de decizie in cadrul autoritatii contractanta , precum si cele care participa la organizarea , derularea si finalizarea procedurii de achizitie :

         Ec. Dobrea Valentina - Alina -Manager

         Dr.Voinescu Doina Carina- Director medical

         Ec.MIhailov Florentina– Director financiar- contabil

         As.Apostol Lacramioara Luminita-Director ingrijiri

         Ec. Mihalea Manuela- presedinte comisie evaluare

         Ing.Tanase Adriana -membru comisie evaluare

         Ing. Monica Andrei - membru comisie evaluare

         Farm. Robu Silvia - membru comisie evaluare

         Jr. Hirlesteanu Iulia- membru comisie evaluare

         Jr. Titea Dumitru - membru de rezerva comisie evaluare

         Farm. Ifrim Ionica- membru de rezerva comisie evaluare

         Modalitate de demonstrare a indeplinirii cerintei : se va completa odata cu depunerea DUAE de catre operatorii paticipanti la procedura ( ofertanti, terti sustinatori, subcontractanti) pana la data limita de depunere a ofertelor

         Cerinta nr. 1

         Capacitatea de exercitare a activitatii profesionale

         Operatorii economici ce depun oferta trebuie sa dovedeasca o forma de inregistrare in conditiile legii din tara de rezidenta, sa reiasa ca operatorul economic este legal constituit , ca nu se afla in niciuna dintre situatiile de anulare a constituirii precum si faptul ca are capacitatea profesionala de a realiza activitatile care fac obiecul contractului.

         Modalitate de indeplinire : Completare DUAE, urmand ca documentul justificativ, respective certificat ONRC, sau pentru ofertantii straini document echivalent emise in tara de rezidenta, sa fie prezentat doar la solicitarea autoritatii contractante la finalizarea evaluarii ofertelor.

         Cerinta nr.2

         Operatorii economici ce depun oferta trebuie sa detina atestare ori apartenenta din punct de vedere profesional respectiv sa detina aviz de la Miniterul Sanatatii valabil la momentul prezentarii, privind autorizatia de functionare a depozitului in conformitate cu Legea 95/2006, art. 800 privind reforma in domeniul sanatatii, Titlul XVIII Medicamentul , cu modificarile si completarile ulterioare si Ordinul ministerului sanatatii publice nr. 1964/2008 pentru aprobarea Normelor privind infiintarea, organizarea si functionarea unitatilor de distributie angro de medicamente de uz uman.

         Modalitate de indeplinire:se va completa DUAE, urmand ca documentul justificativ ( avizul de functionare) sau pentru ofertanti straini , document echivalent emis in tara de rezidenta, sa fie prezentat doar la solicitarea autoritatii contractante la finalizarea evaluarii ofertelor.

      2. Economic and financial standing:
         Selection criteria as stated in the procurement documents
      3. Technical and professional ability:
         List and brief description of selection criteria:

         Loturile: 1,2,3,4,5,6,7Certificate emise de organisme independente cu privire la standardele de asigurare a calitatiiPrezentare dovezii implementarii unui sistem de management al calitatii in conformitate cu SR EN ISO 9001 sau echivalent care sa permita atat prezentarea unui certificate emis de un organism de certificare cat si alte documente care probeaza in mod concludent indeplinirea cerintei.

         Minimum level(s) of standards possibly required:

         Modalitate de demonstrare a indeplinirii cerintei : se va completa DUAE de catre operatorii paticipanti la procedura( ofertanti, terti sustinatori, subcontractanti).

      4. Information about reserved contracts:
         
   2. Conditions related to the contract:
      1. Information about a particular profession:
         
      2. Information about staff responsible for the performance of the contract:
         
4. Section IV
5. Description:
   1. Type of procedure:
      Open procedure
   2. Information about a framework agreement or a dynamic purchasing system:
      Framework agreement with a single operator
   3. Information about reduction of the number of solutions or tenders during negotiation or dialogue:
      
   4. Information about negotiation:
      
   5. Information about electronic auction:
      
   6. Information about the Government Procurement Agreement (GPA):
      The procurement is covered by the Government Procurement Agreement: no
6. Administrative information:
   1. Previous publication concerning this procedure:
      
   2. Time limit for receipt of tenders or requests to participate:
      Date: 2023-12-05
      Local time: 15:00
      
   3. Estimated date of dispatch of invitations to tender or to participate to selected candidates:
      
   4. Languages in which tenders or requests to participate may be submitted:
      RO
   5. Minimum time frame during which the tenderer must maintain the tender:
      Tender must be valid until: 2025-12-05
      (from the date stated for receipt of tender)
      
   6. Conditions for opening of tenders:
      Date: 2023-12-05
      Local time: 15:00
      Place:

      In SEAP

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