81296106-Training and Organizational Development support to the South African Health Products Regulatory Authority to attain WHO Maturity Level 4 Referenznummer der Bekanntmachung: 81296106
Auftragsbekanntmachung
Dienstleistungen
Abschnitt I: Öffentlicher Auftraggeber
Postanschrift: Dag-Hammarskjöld-Weg 1 - 5
Ort: Eschborn
NUTS-Code: DE71A Main-Taunus-Kreis
Postleitzahl: 65760
Land: Deutschland
Kontaktstelle(n): Leinemann Partner Rechtsanwälte mbB
E-Mail:
Fax: +49 6974093874
Internet-Adresse(n):
Hauptadresse: http://www.giz.de
Abschnitt II: Gegenstand
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.
00000 South Africa
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.
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.
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.
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.
Abschnitt III: Rechtliche, wirtschaftliche, finanzielle und technische Angaben
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
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.
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.
It is necessary to provide references in the technical field "public health" with a minimum commission value of 150.000,00 EUR.
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.
Abschnitt IV: Verfahren
Abschnitt VI: Weitere Angaben
The communication with the bidders will only take place via GIZ e-tendering platform (VMS).
Bekanntmachungs-ID: CXTRYY6Y1DWGQLPY
Postanschrift: Villemombler Straße 76
Ort: Bonn
Postleitzahl: 53123
Land: Deutschland
E-Mail:
Telefon: +49 2289499-0
Fax: +49 2289499-163
Internet-Adresse: http://www.bundeskartellamt.de
According to Article 160, Section 3 of the German Act Against Restraint of Competition (GWB), application for review is not permissible insofar as
1. the applicant has identified the claimed infringement of the procurement rules before submitting the application for review and has not submitted a complaint to the contracting authority within a period of 10 calendar days; the expiry of the period pursuant to Article 134, Section 2 remains unaffected,
2. complaints of infringements of procurement rules that are evident in the tender notice are not submitted to the contracting authority at the latest by the expiry of the deadline for the application or by the deadline for the submission of bids, specified in the tender notice
3. complaints of infringements of procurement rules that first become evident in the tender documents are not submitted to the contracting authority at the latest by the expiry of the deadline for application or by the deadline for the submission of bids,
4. more than 15 calendar days have expired since receipt of notification from the contracting authority that it is unwilling to redress the complaint.
Sentence 1 does not apply in the case of an application to determine the invalidity of the contract in accordance with Article 135, Section 1 (2). Article 134, Section 1, Sentence 2 remains unaffected.