Pharmaceutical products (Македония - Тендер #42698219)

1. Section I
   1. Name and addresses
      Public Health Institution Clinic for children diseases
      st. Vodnjanska, 17
      Skopje
      1000
      Macedonia
      Telephone: +38 923147521
      E-mail: jzuklinikazadetskibolesti@yahoo.com
      Fax: +38 923129027
      
   2. Joint procurement
      
   3. Communication
      The procurement documents are available for unrestricted and full direct access, free of charge, at
      https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a04d4a42-e92e-4420-b625-f46afdc40d54/1
      Additional information can be obtained from the abovementioned addresselectronically via: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a04d4a42-e92e-4420-b625-f46afdc40d54/1
      
      
   4. Type of the contracting authority:
      Other type: authority of clinic
      
   5. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         Procurement of medicines from the Conditional budget - Biological therapy

      2. Main CPV code:
         33600000
         
      3. Type of contract:
         Supplies
         
      4. Short description:
         

         Procurement of medicines from the Conditional budget - Biological therapy

      5. Estimated total value:
         
         
      6. Information about lots:
         all lots
   2. Description
      1. Title:
         

         L04AB04 Adalimumab -originator solution for injection in pre-filled injection pen 40 mg/0.4 ml 2 pre-filled injection pens +2 alcohol swabs/box piece 156

         Lot No: 1
         
      2. Additional CPV code(s):
         33600000
         
      3. Place of performance:
         
      4. Description of the procurement:
         

         L04AB04 Adalimumab -originator solution for injection in pre-filled injection pen 40 mg/0.4 ml 2 pre-filled injection pens +2 alcohol swabs/box piece 156

      5. Award criteria:
         
      6. Estimated value:
         
         
      7. Duration of the contract, framework agreement or dynamic purchasing system:
         Duration in months: 12
         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:
          

          L04AB02 Infliximab powder for concentrate for solution for infusion 100 mg 1 glass vial x 100 mg / box piece 129

          Lot No: 2
          
      15. Additional CPV code(s):
          33600000
          
      16. Place of performance:
          
      17. Description of the procurement:
          

          L04AB02 Infliximab powder for concentrate for solution for infusion 100 mg 1 glass vial x 100 mg / box piece 129

      18. Award criteria:
          
      19. Estimated value:
          
          
      20. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 12
          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:
          

          L04AB02 Infliximab originator powder for concentrate for solution for infusion 100 mg 1 glass vial x 100 mg / box piece 75

          Lot No: 3
          
      28. Additional CPV code(s):
          33600000
          
      29. Place of performance:
          
      30. Description of the procurement:
          

          L04AB02 Infliximab originator powder for concentrate for solution for infusion 100 mg 1 glass vial x 100 mg / box piece 75

      31. Award criteria:
          
      32. Estimated value:
          
          
      33. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 12
          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:
          

          L04AC03 Anakinra solution for injection 100 mg 7 pre-filled injection pens piece 730

          Lot No: 4
          
      41. Additional CPV code(s):
          33600000
          
      42. Place of performance:
          
      43. Description of the procurement:
          

          L04AC03 Anakinra solution for injection 100 mg 7 pre-filled injection pens piece 730

      44. Award criteria:
          
      45. Estimated value:
          
          
      46. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 12
          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:
          

          L04AB01 Etanercept 0riginator solution for infusion 50 mg 4 pre-filled injection pens (MYCLIC)+4 alcohol swabs/box piece 52

          Lot No: 5
          
      54. Additional CPV code(s):
          33600000
          
      55. Place of performance:
          
      56. Description of the procurement:
          

          L04AB01 Etanercept 0riginator solution for infusion 50 mg 4 pre-filled injection pens (MYCLIC)+4 alcohol swabs/box piece 52

      57. Award criteria:
          
      58. Estimated value:
          
          
      59. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 12
          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:
          
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:

         a statement by the economic operator that for the last 5 years the economic operator or the person who is a member of the management or supervisory body of that economic operator or who has powers to represent or make decisions or supervise it has not in the last 5 years pronounced final court verdict for a criminal offense that has elements of criminal misconduct, corruption, tax evasion and contributions, terrorism or criminal

         133 / 135

         offenses related to terrorist activities, money laundering and finance combating terrorism and child labor and human trafficking, as set forth in the Criminal Code;

         — confirmation of paid taxes, contributions and other public duties by a competent authority of the country where the economic operator is registered;

         — confirmation that no bankruptcy procedure has been initiated by a competent authority or a single document proving the capability;

         — confirmation that no liquidation procedure has been initiated by a competent authority or a single document proving its capability;

         — confirmation from the Register of penalties for the criminal offenses of legal entities that no secondary penalty has been imposed for not participating in public procurement procedures, awarding public procurement contracts and public-private partnership contracts or a unique document proving ability;

         — confirmation from the Register of penalties for the criminal offenses of the legal entities that it has not been imposed a secondary penalty — temporary prohibition for performing certain activity or single document for proving the capability;

         — confirmation from the Register of penalties for the criminal offenses of the legal entities that no secondary penalty has been pronounced for permanent prohibition to perform certain activity or single document for proving the capability;

         — confirmation that a final judgment has not imposed a misdemeanor sanction — prohibition to perform a profession, activity or duty or a unique document proving his ability; and

         — confirmation that a final judgment has not imposed a misdemeanor sanction — a temporary ban on performing a particular activity or a unique document proving his ability.

         Capacity for performing professional activity of the economic operator:

         Document for registered activity — DRD Form or confirmation for registered activity.

         Resolution for wholesale medical supplies in line with the Law on Medicine and Medical De

      2. Economic and financial standing:
         
      3. Technical and professional ability:
         List and brief description of selection criteria:

         Required documents for proving the technical and professional capacity of the economic operator:

         Conditions for safe storage, accommodation, transport and handling of medications should be in accordance with the rulebook on the contents of the request and more detailed conditions regarding the space, equipment

         6 / 7

         and staff for obtaining a wholesale medicines approval (‘Official Gazette of the Republic of Macedonia’ number 151/08);

         — it is required to own a chamber for storage and storage with automatic reader of the temperature that needs to be continuously maintained from 2-8 ºC with the capacity appropriate to the offered drugs quantities that are the subject of procurement and require a special temperature regime;

         — it needs to have a suitable vehicle for the transport and distribution of medicines;(equipped with temperature storage mode from 20 ºC to 80 ºC) for drugs that are subject to procurement and need special temperature regime;

         — to have sound and visual signaling from the chamber to the person in charge for 24-hour monitoring of the cold chain;

         — to have a spare unit for supplying electricity, which is activated in case of power failure;

         Minimum level(s) of standards possibly required:

         statement that it meets the requirements for safe storage, accommodation, transport and handling medicines that should comply with the Rulebook on the content of the application and detailed conditions regarding space,

         134 / 135

         equipment and personnel for obtaining a wholesale permit for medicines (‘Official Gazette of the Republic of Macedonia’ No 151/08);

         — statement that it has a cooling chamber with automatical built-in thermometer (from 20C to 80C for the offered drugs that require storage in this range) and a temperature reader for the drug chamber that is a subject of procurement and needs a special temperature regime;

         — statement that it has a suitable vehicle for transport and distribution of drugs; (to be equipped with a temperature mode of storage from 20 ºC to 80 ºC);

         — statement that it will provide a person in charge of 24-hour monitoring and keeping the normal running of the cold chain and who will raise the alarm in case of variations in the temperature range provided for storage of drugs; for part - to submit M1M2 evidence for 1 (one) employed graduated pharmacist with passed professional exam and work license, liable for procurement phases (reception, storage and issuing of medicines);

         — statement that it has an aggregate for additional power supply to the cooling chamber

      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:
      
   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: 2023-07-07
      Local time: 14:00
      
   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:
      MK
   5. Minimum time frame during which the tenderer must maintain the tender:
      (from the date stated for receipt of tender)
      
   6. Conditions for opening of tenders:
      Date: 2023-07-07
      Local time: 14:00
      

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