Public procurement notice: Contract Notice
Published: 2023-05-17
Buyer: Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
Country: DE
Contract type: Services
Procedure: Competitive procedure with negotiation
CPV classification: 71317200 | 85000000 | 85100000: Health services
Submission deadline: 2023-06-14
Award criteria: The most economic tender

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

Eligibility requirements: 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