Medical equipments, pharmaceuticals and personal care products (Македония - Тендер #49412332)

1. Section I
   1. Name and addresses
      JZU University institute of positron emission tomography
      Bledski dogovor 10, Skopje, Karpos 3
      Skopje
      1000
      Macedonia
      Telephone: +389 23078098
      E-mail: filipovski.zlatko@gmail.com
      Fax: +389 23078098
      
   2. Joint procurement
      
   3. Communication
      Access to the procurement documents is restricted. Further information can be obtained at
      https://e-nabavki.gov.mk/PublicAccess/Home.aspx#/home
      Additional information can be obtained from the abovementioned addressto the abovementioned address
      
   4. Type of the contracting authority:
      Body governed by public law
      
   5. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         Equipment for development of new radiopharmaceuticals

         Reference number: 22788/2023
         
      2. Main CPV code:
         33000000
         
      3. Type of contract:
         Supplies
         
      4. Short description:
         

         Equipment for development of new radiopharmaceuticals:

         1. Liquid target for production of 68Ga compatible with GE PETtrace 860 cyclotron - Target for production of radioactive isotope of 68Ga with a cyclotron. The target should be compatible with a GE PETtrace 860 cyclotron and be able to connect and mount on its vacuum chamber:

         • Energy of proton beam of the cyclotron– 16.5 MeV.

         • Maximum current during dual beam irradiation– 100 µA.

         2. Equipment for synthesis of 68Ga radiopharmaceuticals - The equipment for purification of cyclotron produced 68Ga radioisotope in liquid form and synthesis of 68Ga radiopharmaceuticals should fulfill all quality requirements and acceptance criteria defined in the European Pharmacopoeia monographs.

      5. Estimated total value:
         Value excluding VAT: 11 000 000.00 MKD
         
      6. Information about lots:
         This contract is divided into lots: no
   2. Description
      1. Title:
         
      2. Additional CPV code(s):
         33000000
         
      3. Place of performance:
         Main site or place of performance:

         PHI UI for PET

         st. Bledski dogovor No.10, Skopje, Republic of North Macedonia

      4. Description of the procurement:
         

         Equipment for development of new radiopharmaceuticals:

         1. Liquid target for production of 68Ga compatible with GE PETtrace 860 cyclotron - Target for production of radioactive isotope of 68Ga with a cyclotron. The target should be compatible with a GE PETtrace 860 cyclotron and be able to connect and mount on its vacuum chamber:

         • Energy of proton beam of the cyclotron– 16.5 MeV.

         • Maximum current during dual beam irradiation– 100 µA.

         2. Equipment for synthesis of 68Ga radiopharmaceuticals - The equipment for purification of cyclotron produced 68Ga radioisotope in liquid form and synthesis of 68Ga radiopharmaceuticals should fulfill all quality requirements and acceptance criteria defined in the European Pharmacopoeia monographs.

      5. Award criteria:
         
      6. Estimated value:
         Value excluding VAT: 11 000 000.00 MKD
         
      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:
          
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:

         In order to prove its personal situation, the economic operator should provide the following documents:

         — statement that in the last 5 years no effective court verdict has been pronounced for committed criminal act from Article 88 paragraph 1 of the PPL,

         — certificate that it is not subject to bankruptcy procedure issued by competent authority,

         — certificate that it is not subject to liquidation procedure issued by competent authority,

         — certificate for paid taxes, contributions and other public duties by the competent authority in the country where that economic operator is established,

         — certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction – prohibition to participate in public competitions, contract award procedures and PPP award procedures,

         — certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity,

         — certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing professional

         Document for registered activity - DRD form or certificate for registered activity

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

         1. To have a valid certificate for training of at least one person issued by the manufacturer of cyclotron.

         2. To have a valid certificate for training of at least one person issued by the manufacturer of the equipment for purification and synthesis.

         Minimum level(s) of standards possibly required:

         1. Valid certificate for training of at least one person issued by the manufacturer of the cyclotron.

         2. Valid certificate for training of at least one person issued by the manufacturer of the equipment for purification and synthesis.

      4. Information about reserved contracts:
         
   2. Conditions related to the contract:
      1. Information about a particular profession:
         Contract performance conditions:

         1. The following method of payment is envisaged: payment within 60 days, 50% (of the total price) after delivery of the equipment on site at PHI UI for PET – Skopje, Republic of North Macedonia after a duly submitted invoice and signed document for acceptance of the equipment and 50% (of the total price) after installing, starting and testing the equipment for normal functioning. Any bid containing a method of payment other than that specified in this item will be considered unacceptable and as such will be rejected by the Public Procurement Commission.

         2. The deadline for delivery of the equipment is 4 months from the date of signing the contract, while the deadline for installation and starting the normal functioning of the equipment is 2 months from the date of delivery of the equipment on site. Place of delivery of the equipment is PHI UI for PET – st. Bledski dogovor No.10 Skopje, Republic of North Macedonia.

      2. Information about staff responsible for the performance of the contract:
         Obligation to indicate the names and professional qualifications of the staff assigned to performing 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: 2024-01-22
      Local time: 10:00
      
   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:
      EN, 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: 2024-01-22
      Local time: 10:00
      Place:

      PHI UI for PET

      st. Bledski dogovor No.10, Skopje, Republic of North Macedonia

Источник закупки

Импорт - Экспорт по стране Македония