Health services (Германия - Тендер #41924169)

1. Section I
   1. Name and addresses
      Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
      Dag-Hammarskjöld-Weg 1 - 5
      Eschborn
      65760
      Germany
      E-mail: giz@leinemann-partner.de
      Fax: +49 6974093874
      
   2. Joint procurement
      
   3. Communication
      The procurement documents are available for unrestricted and full direct access, free of charge, at
      https://ausschreibungen.giz.de/Satellite/notice/CXTRYY6Y1DWGQLPY/documents
      Additional information can be obtained from the abovementioned addresselectronically via: https://ausschreibungen.giz.de/Satellite/notice/CXTRYY6Y1DWGQLPY
      
      
   4. Type of the contracting authority:
      Other type: Legal person governed by private law (gemeinnützige GmbH) wholly owned by the Federal Republic of Germany
      
   5. Main activity:
      Other activity: International Development Cooperation
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         81296106-Training and Organizational Development support to the South African Health Products Regulatory Authority to attain WHO Maturity Level 4

         Reference number: 81296106
         
      2. Main CPV code:
         85100000
         
      3. Type of contract:
         Services
         
      4. Short description:
         

         The Covid-19 pandemic magnified the critical need for Africa to be able to increase its ability to respond to pandemics and other health crises. The COVID-19 pandemic had a devastating effect on South Africa. It is against this background that the German Federal Ministry for Economic Cooperation and Development (BMZ), committed its support to South Africa through the project, Vaccines for Africa: Vaccine Roll Out and Production in South Africa (SAVax). The project SAVax is commissioned by BMZ and implemented by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH between January 2022 and December 2025.

         SAVax"s objective is to improve access to vaccines for all population groups in South Africa. In order to achieve this objective, the project works along two components, (a) supporting the COVID-19 vaccine roll-out and; (b) strengthening the main stakeholders for vaccine production in South Africa. This tender will focus on the second component (b), the strengthening of local vaccine production in South Africa.

         A key stakeholder in vaccine production is the national regulatory authority that ensures the quality and safety of vaccines produced. SAVax is working to provide technical support to South Africa"s regulatory authority, i.e., South African Health Products Regulatory Authority (SAHPRA). The goals of the technical support will be to strengthen the capacity of SAHPRA to regulate the vaccine and pharmaceutical sector in South Africa using efficient digital work processes.

         SAHPRA has set itself a goal to reach World Health Organization (WHO) Maturity Level (ML) 4 by 2025. The categorization of WHO ML 4 gives the assessment that a country"s regulatory system is operating at an advanced level of performance and continuous improvement. Through the technical support provided by SAVax to SAHPRA, the goal of the tender will be to support SAHPRA to attain WHO ML 4 status by 2025.

         It is within this context that informs the needs for this Terms of Reference (ToR), to find a suitable contractor to support the objectives as described of SAVax"s collaboration with SAHPRA.

      5. Estimated total value:
         
         
      6. Information about lots:
         This contract is divided into lots: no
   2. Description
      1. Title:
         
      2. Additional CPV code(s):
         71317200, 85000000
         
      3. Place of performance:
         Main site or place of performance:

         00000 South Africa

      4. Description of the procurement:
         

         The project "Vaccines for Africa: Roll-out and Production in South Africa" (SAVax) is commissioned by the German Ministry for Economic Cooperation and Development (BMZ) and implemented by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH between January 2022 and December 2025. SAVax"s objective is to improve access to vaccines for all population groups in South Africa.

         For SAVax to achieve this objective, the project works along two components: (a) Support to the COVID-19 vaccine roll-out in South Africa and (b) Strengthening of the main stakeholders for local production of vaccines in South Africa. The services to be provided focus on component (b) to strengthen local vaccine production in South Africa.

         The backbone of being able to produce local vaccines is to have an efficient national regulatory authority to ensure the quality and safety of the vaccines produced. SAVax is providing technical support to South Africa"s regulatory authority, the South African Health Products Regulatory Authority (SAHPRA), to strengthen the capacity of SAHPRA to regulate the vaccine and pharmaceutical sector in South Africa.

         The South African National Control Laboratory for Biological Products (SANCL) conducts vaccine release testing. SANCL services SAHPRA exclusively to perform Human vaccine Lot Release before product is released into the market.

         The technical support provided by SAVax to SAHPRA has been bracketed into four activities: (a) training interventions for key regulatory processes, (b) organizational development, (c) digitalization of central work-processes of the organization, and (d) support for the coordination of development partner support. The services requested of the contractor for this tender will focus on activities (a) and (b).

         The contractor will be responsible for delivering the following work packages to fulfil the technical support. The work packages as described below will be segmented into milestones with defined outputs and delivery dates.

         - Work Package 1 - Training Interventions: The contractor will conduct training interventions (assessments, curriculum, training implementation) for SAHPRA and the SANCL. The training required is for SAHPRA and SANCL staff, on various regulatory topics relevant for SAHPRA to reach WHO ML 4 status. Following five regulatory topics for training interventions have been identified through a series of workshops with SAHPRA are:

         a) Good Manufacturing Practice (GMP) Inspection of biological medicines and vaccines manufacturers,

         b) Clinical Trials Evaluation,

         c) Biological and Biosimilar medicines and Vaccine dossier evaluation process,

         d) Clinical and Bioequivalence Evaluation

         e) Vaccines lot release.

         - Work Package 2 - Organizational Development: The contractor is expected to provide services in support of SAHPRA"s organizational development in context of achieving WHO ML4 and the anticipated evolution and requirements of the regulatory and pharmaceutical landscape in the mid to long term of South Africa and broader continental needs. The service to be provided entails (a) assessment of the future regulatory environment of SAHPRA, (b) support to SAHPRA in shaping and defining an organizational culture, (c) development of a change management strategy/plan as well as (d) providing training interventions for the development of relevant change management skills for SAHPRA staff.

         Experts for Work Package 1 and Work Package 2:

         The contractor will be required to provide the below listed experts to fulfil the training goals of Work Package 1. The experts listed will provide training in the designated regulatory topics to SAHPRA and SANCL staff. The contractor will also be required to provide and pool of 3 experts (an expert pool) to fulfil the goals of Work Package 2

         (1) Team-lead for the overall coherence and co-ordination of the work packages and training.

         (2) Trainer for GMP Inspections of biological medicines and vaccines manufacturers

         (3) Trainer for Clinical Trials Evaluation

         (4) Trainer for Biological and Biosimilar medicines and Vaccine dossier evaluation process

         (5) Trainer for Clinical and Bioequivalence Evaluation

         (6) Trainer for Vaccine Lot Release

         (7) Assessor of future regulatory environment relevant for SAHPRA

         (8) An expert pool for Organizational Development of SAHPRA.

         A description of the experience and qualifications of each expert is detailed in the accompanying Terms of Reference (ToR). Project timelines, milestones and format of the tender are also detailed in the ToR, including further context and description of services to be provided by the contractor.

      5. Award criteria:
         Price is not the only award criterion and all criteria are stated only in the procurement documents
      6. Estimated value:
         
         
      7. Duration of the contract, framework agreement or dynamic purchasing system:
         
         Start: 2023-11-15
         End: 2024-12-31
         This contract is subject to renewal: yes
         Description of renewals:

         GIZ is entitled to extend the period for fulfilment of the original contract by unilaterally notifying the Contractor. For details, please see the special terms and conditions.

      8. Information about the limits on the number of candidates to be invited:
         Envisaged minimum number: 3
         Maximum number: 5
         Objective criteria for choosing the limited number of candidates:

         The assignment will only be entrusted to companies with the required expertise and capacity (eligible companies), which meet the criteria listed in the document "Request to participate and Eligibility declaration by applicants (Call for competition)", and which are not excluded under the terms of Sections 123 or 124 of the German Act against Restraints of Competition (GWB) or who can prove restoration of their integrity in line with Section 125 of the same act and also not excluded under the terms of section 22 LkSG.

         If there is a previously announced limit to the number of applicants, an assessment will be carried out according to the relevant evaluation scale included in the tender documents.

      9. Information about variants:
         Variants will be accepted: no
         
      10. Information about options:
          Options: yesDescription of options:

          GIZ may optionally commission contract amendments and/or increases based on the criteria in the tender documents to the successful bidder of this tender. For details, please see the special terms and conditions.

      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:

         1. Trading name and address, commercial register excerpt.

         2. Eligibility declaration that no grounds for exclusion in Section 123, 124 of the German Act Against Restraints of Competition (GWB) and in Section 22 LkSG apply.

         3. Eligibility declaration subcontractors if applicable.

         4. Association clause if applicable

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

         1. Declaration on the average annual turnover for the last 3 financial years (last-but-four financial year can be included in case of invitation to tender held within 6 months of end of last financial year);

         2. Declaration of the average number of employees and managers for the past three calendar years.

         Minimum level(s) of standards possibly required:

         1. Average annual turnover for the last three years at least 1.900.000,00 EUR.

         2. Declaration of the average number of employees and managers for the past three calendar years at least 12 persons.

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

         It is necessary to provide references in the technical field "public health" with a minimum commission value of 150.000,00 EUR.

         Minimum level(s) of standards possibly required:

         1. At least 2 reference projects in the technical field of "public health" and at least 1 reference project in the World in the last 3 years.

         2. The technical assessment is only based on reference projects with a minimum commission value of 150.000,00 EUR.

      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:
      Competitive procedure with negotiation
   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:
      Recourse to staged procedure to gradually reduce the number of solutions to be discussed or tenders to be negotiated
   4. Information about negotiation:
      The contracting authority reserves the right to award the contract on the basis of the initial tenders without conducting negotiations
   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: 2023-06-14
      Local time: 12:00
      
   3. Estimated date of dispatch of invitations to tender or to participate to selected candidates:
      Date: 2023-07-04
      
   4. Languages in which tenders or requests to participate may be submitted:
      EN
   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:
      

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