Diphtheria-pertussis-tetanus vaccines (Норвегия - Тендер #45753471)

1. Section I
   1. Name and addresses
      Folkehelseinstituttet
      Lovisenberggata 8
      OSLO
      0456
      Norway
      Telephone: +47 21076629
      E-mail: ole.andreas.fuglesang@fhi.no
      
   2. Joint procurement
      
   3. Communication
      The procurement documents are available for unrestricted and full direct access, free of charge, at
      http://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=378218&B=DFO
      Additional information can be obtained from the abovementioned addresselectronically via: http://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=378218&B=DFO
      to the abovementioned address
      
   4. Type of the contracting authority:
      Ministry or any other national or federal authority, including their regional or local subdivisions
      
   5. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         Pertussis vaccine for maternal immunisation

         Reference number: 23/00780
         
      2. Main CPV code:
         33651610
         
      3. Type of contract:
         Supplies
         
      4. Short description:
         

         The Norwegian Institute of Public Health is holding an open tender contest with the aim of entering into a contract for the supply of vaccines suitable for vaccination against pertussis during pregnancy (maternal vaccination, vaccination of pregnant women). In practice, this would mean a combination vaccine against diphtheria, tetanus and pertussis, without a polio component.

      5. Estimated total value:
         Value excluding VAT: 37 400 000.00 NOK
         
      6. Information about lots:
         This contract is divided into lots: no
   2. Description
      1. Title:
         
      2. Additional CPV code(s):
         33651600, 33651620
         
      3. Place of performance:
         Main site or place of performance:

         Oslo

      4. Description of the procurement:
         

         The Norwegian Institute of Public Health is holding an open tender contest with the aim of entering into a contract for the supply of vaccines suitable for vaccination against pertussis during pregnancy (maternal vaccination, vaccination of pregnant women). In practice, this would mean a combination vaccine against diphtheria, tetanus and pertussis, without a polio component.

         In accordance with Tender documentation, chapter 5 "Requirements specification" sets the minimum requirement that the vaccine must be approved for the vaccination of pregnant women against pertussis, and that the vaccine must not contain a polio component. There are also other minimum requirements for the vaccine. See chapter 5 of the tender documentation.

         NIPH aims to award a contract to one tenderer for a contract period of 2+1+1 years, with the last two years being option years. NIPH would like the first delivery at the latest by early Q2 in 2024. Furthermore, the aim is to build up a buffer stock during 2024. The desired number of doses for 2024 is therefore higher than for subsequent years.

         Prior to the procurement, NIPH has conducted a market survey that was published on Doffin (ref. 2023-644100). In addition, updated information has subsequently been obtained from the suppliers who provided input in the market survey. NIPH received useful input from the supplier market. Based on the input received, it has been decided to allow foreign vaccine packs to be delivered during the start-up phase, but it is preferable for Norwegian packs to be delivered as soon as possible. There is a minimum requirement for the delivery of Norwegian packs by the end of 2024 at the latest and for the duration of the agreement.

         Start-up of maternal pertussis vaccination requires public funding. The issue of funding will be part of the consideration for the national budget for 2024. Provided that funding is approved, the contracting authority aims to sign a contract as soon as possible afterwards. The latest date for the contract to be signed is expected to be December 2023. If funding is not provided, the tender contest may be cancelled.

         The volume of the procurement (number of doses) is stated as a range per year

         2024: Minimum volume: 77,900 doses Maximum volume 86,100 doses

         2025: Minimum volume: 49,400 doses Maximum volume: 54,600 doses

         2026 (option): Minimum volume: 49,400 doses Maximum volume: 54,600 doses

         2027 (option): Minimum volume: 49,400 doses Maximum volume: 54,600 doses

         See the tender documentation for more information, including information about foreign packages and package size.

      5. Award criteria:
         
      6. Estimated value:
         Value excluding VAT: 37 400 000.00 NOK
         
      7. Duration of the contract, framework agreement or dynamic purchasing system:
         Duration in months: 24
         This contract is subject to renewal: yes
         Description of renewals:

         The contract period is 2 years, with an option for 1+1 year extension. The option for an extension will be automatically taken up for one year at a time, unless the contracting authority gives notice on the contract in accordance with the Supply Agreement, point 17. The contracting authority aims to sign the contract shortly after the procurement is implemented.

      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: yesDescription of options:

          The contract period is 2 years, with an option for 1+1 year extension. The option for an extension will be automatically taken up for one year at a time, unless the contracting authority gives notice on the contract in accordance with the Supply Agreement, point 17. The contracting authority aims to sign the contract shortly after the procurement is implemented.

      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:

         Tenderers must be registered in a company register, professional register or a trade register in the country where the tenderer is established.

         Norwegian companies: Company registration certificate

         Foreign tenderers: Verification showing that the tenderer is registered in a company register, professional register or a commerce register in the country where the tenderer is established.

      2. Economic and financial standing:
         List and brief description of selection criteria:

         Tenderers must have sufficient economic and financial capacity to fulfil the agreement. Creditworthiness with no requirement for guarantees will be sufficient to meet the requirement.

         Documentation requirement:

         Credit assessment based on the most recent accounting figures. The rating must be carried out by a credit rating agency with a licence to provide such service. If a tenderer has valid reasons for not being able to provide the documentation requested by the contracting authority, the tenderer can document his economic and financial capacity by presenting other documents considered suitable by the contracting authority.

      3. Technical and professional ability:
         List and brief description of selection criteria:

         Tenderers must have the requisite permissions to be able to fulfil the contract.

         Documentation requirement:

         If the tenderer is the manufacturer of the vaccine, permission must be presented from relevant EU/EEA authorities to manufacture pharmaceuticals.

         If the tenderer is not the manufacturer of the vaccine, the requisite permissions from relevant EU/EEA authorities to trade in pharmaceuticals must be presented.

         If the tenderer imports the vaccine, the import license that includes the offered vaccine must be presented.

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

         • The Norwegian Institute of Public Health requires ethical and socially responsible production. (Supply agreement point 12, 12.1 – 12.3).

         • Tenderers must be a member of the Legemiddelansvarsforeningen [Pharmaceutical Liability Association] (Supply Agreement, point 11.2)

         The Norwegian Institute of Public Health (NIPH) can re-sell, non-distributed, vaccine doses (Supply Agreement, point 18.1)

         • NIPH is, for every year of the entire contract period, bound to procure a stated minimum number of doses (Supply Agreement point 3.2)

         • The tenderer is, for every year of the entire contract period, obliged to deliver up to the stated maximum number of doses (Supply Agreement point 3.3)

         - Per agreement between the parties, the packaging of the vaccine may be changed during the contract period. This includes changes in MT number, pack size and language (Supply Agreement section 3.4)

      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: yes
6. Administrative information:
   1. Previous publication concerning this procedure:
      
   2. Time limit for receipt of tenders or requests to participate:
      Date: 2023-10-09
      Local time: 13:00
      
   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, NO
   5. Minimum time frame during which the tenderer must maintain the tender:
      Tender must be valid until: 2024-01-15
      (from the date stated for receipt of tender)
      
   6. Conditions for opening of tenders:
      Date: 2023-10-09
      Local time: 13:00
      Place:

      Electronic tender opening in NPHI"s tender management tool.

      Information about authorised persons and opening procedure:

      Two NIPH employees with user access to the tender management system

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