Context
The Pharmacy and Medicines Regulatory Authority (PMRA) is a national medicine regulatory Authority in Malawi, established by an Act of Parliament. PMRA is mandated to regulate the manufacture, importation, distribution, sale and use of medicines and allied substances in order to ensure their safety, efficacy and quality. Its primary goal is to safeguard public health by ensuring that all medical products available on the Malawian market meet established standards.
Recognizing the critical need for the data driven action, PMRA, in collaboration with the African Union Development Agency- New Partnership for Africa’s Development (AUDA-NEPAD), seeks the services of a qualified consultant to conduct a comprehensive prevalence study on substandard and falsified medical products in Malawi. The findings will support the development of the National Action Plan and devise targeted strategies to strengthen regulatory systems, enhance post-marketing surveillance efforts, and protect public health.
Substandard and falsified medical products (SFMP) represent a significant threat to a national health security, antimicrobial resistance, and erode public trust in health systems with implications ranging from treatment failure and prolonged illness to death. These products may contain incorrect doses, harmful ingredients, or no active ingredients at all, rendering them ineffective or dangerous. Despite ongoing regulatory efforts, there is limited empirical data in Malawi on the actual prevalence, sources, and distribution channels of SF medicines, posing challenges to regulatory enforcement and public health response.
Objectives:
The prevalence study is therefore important to establish baseline data on the burden and nature of the problem. Such evidence is crucial for informing strategic regulatory actions, guiding resource allocation, and enhancing collaboration among key stakeholders, including law enforcement agencies, customs, healthcare providers, and development partners.
This study will also align with regional and continental efforts, including AUDA-NEPAD’s initiatives under the African Medicines Regulatory Harmonization (AMRH) framework, which aim to strengthen national regulatory systems and combat proliferation of SF medicines. Ultimately, the findings from this study will contribute to safeguarding public health and promoting access to quality assured medicines in Malawi, including by informing the development of a national strategy against SFMP.
To support the AMRH and the PMRA, a consultancy is desired, based on the following broad objectives. The objectives are to benefit the AMRH and the PMRA in their efforts against
SFMP.
Tasks to be performed by the contractor
The purpose of this consultancy is to design and conduct a national-level prevalence study to estimate the burden of substandard and falsified medical products in selected regions of Malawi, identify common types and sources, and assess contributing factors.
The following are the main objectives;
- To estimate the prevalence of substandard and falsified medical products in selected health facilities and private sector outlets.
- To identify the most commonly affected types of medicines and their therapeutic classes.
- To assess distribution channels and risk factors associated with the presence of SF medicines.
- To provide recommendations for improving surveillance, regulation, and enforcement mechanisms.
The contractor is responsible for providing the following services:
- Conducting a desk review of existing studies and regulatory data on SF medicines in Malawi and similar contexts.
- Designing the study methodology, including sampling framework, data collection tools, and analytical strategy.
- Obtaining ethical and regulatory approvals for the study.
- Coordinating field data collection from a representative sample of public and private medicine outlets across selected regions.
- Coordinate laboratory testing of collected samples in collaboration with the National Medicines Quality Control Laboratory or other accredited quality control laboratories.
- Data analysis, interpretation, and preparation of a comprehensive report.
- The contractor manages costs and expenditures, accounting processes and invoicing in line with the requirements of GIZ.
- The contractor reports regularly to PMRA, AMRH and GIZ.
- Dissemination of research results through a report and a presentation at the end of the data collection phase by technical experts working at PMRA to AMRH and GIZ as the primary target group. The purpose is to present and discuss the preliminary results with stakeholders. This will help in interpreting the data and finalizing the results.
Certain milestones, as laid out in the table below, are to be achieved during the contract term:
Period of assignment: from 23.10.2025 until 20.04.2026 (6 months).
- Concept
In the tender, the tenderer is required to show how the objectives defined in Chapter 2 (Tasks to be performed) are to be achieved, if applicable under consideration of further method-related requirements (technical-methodological concept). In addition, the tenderer must describe the project management system for service provision.
Note: The numbers in parentheses correspond to the lines of the technical assessment grid.
Technical-methodological concept
Strategy (1.1): The tenderer is required to consider the tasks to be performed with reference to the objectives of the services put out to tender (see Chapter 1 Context) (1.1.1). Following this, the tenderer presents and justifies the explicit strategy with which it intends to provide the services for which it is responsible (see Chapter 2 Tasks to be performed) (1.1.2).
The tenderer is required to present the actors relevant for the services for which it is responsible (1.2.1) and describe the cooperation (1.2.2) with them.
The tenderer is required to present and explain its approach to steering the measures with the project partners (1.3.1). The consultant will report to the Compliance and Enforcement Manager at the Pharmacy and Medicines Regulatory Authority and work closely with the Premises Inspection Officer at PMRA, AUDA NEPAD and relevant stakeholders. Regular updates will be provided through scheduled progress meetings.
The tenderer is required to describe the key processes for the services for which it is responsible and create an operational plan or schedule (1.4.1) that describes how the services according to Chapter 2 (Tasks to be performed by the contractor) are to be provided. In particular, the tenderer is required to describe the necessary work steps and, if applicable, take account of the milestones and contributions of other actors (partner contributions) in accordance with Chapter 2 (Tasks to be performed) (1.4.2).
The tenderer is required to describe its contribution to knowledge management for the partner (1.5.1) under learning and innovation. All data collected during the study will remain the property of the PMRA. The consultant shall not share or publish any part of the data or findings without prior written consent from the PMRA.
Project management of the contractor (1.6)
The tenderer is required to explain its approach for coordination with the PMRA, AMRH and the GIZ project (1.6.1). In particular, the project management requirements specified in Chapter 2 (Tasks to be performed by the contractor) must be explained in detail, including the proposed personnel concept, workplan and responsibilities (1.6.2).
- Personnel concept
The tenderer is required to provide personnel who are suited to filling the positions described, on the basis of their CVs (see Chapter 7), the range of tasks involved and the required qualifications.
The below specified qualifications represent the requirements to reach the maximum number of points in the technical assessment.
Key expert
Tasks of the key expert
- Overall responsibility for the advisory packages of the contractor (quality and deadlines)
- Coordinating and ensuring communication with GIZ, partners and others involved in the project
- Regular reporting in accordance with deadlines
Qualifications of the key expert
- Education/training (2.2.1): university degree (Master) in Public Health, Epidemiology, or a related field
- Language (2.2.2): C1-level language proficiency in English
- General professional experience (2.2.3): 7 years of experience in pharmaceutical quality assurance, public health research, or regulatory systems.
- Specific professional experience (2.2.4):
- Demonstrated experience of conducting prevalence studies or medicine quality assessments.
- Familiarity with WHO guidelines on SF medicines and quality control procedures.
- Strong analytical and report-writing skills.
- Regional experience (2.2.6): 7 years of experience in projects in Africa (region)
- Specific professional experience (2.2.4):
Local expert
Tasks of the local expert
- Support the key expert in their responsibility for the advisory packages of the contractor (quality and deadlines)
- Coordinating and ensuring communication with local partners
- Regular reporting and close coordination with the key expert
Qualifications of the local expert
- Education/training (2.3.1): university degree (Master) in Public Health, Epidemiology, or a related field
- Language (2.3.2): C1-level language proficiency in English
- General professional experience (2.3.3): 7 years of experience in pharmaceutical quality assurance, public health research, or regulatory systems.
- Specific professional experience (2.3.4):
- Demonstrated experience of conducting prevalence studies or medicine quality assessments.
- Familiarity with the context of SFMP in Malawi
- Strong analytical and report-writing skills.
- Regional experience (2.3.6): 7 years of experience in projects in Malawi
Costing requirements
Assignment of personnel and travel expenses
Per diem allowances are reimbursed as a lump sum up to the maximum amounts permissible under tax law for each country as set out in the country table in the circular from the German Federal Ministry of Finance on travel expense remuneration (downloadable from the German Federal Ministry of Finance – tax treatment of travel expenses and allowances for international business travel as of 1 January 20242025 (GERMAN ONLY)).
Accommodation allowances are reimbursed as detailed in the specification of inputs below.
With special justification, additional Accommodation costs up to a reasonable amount can be reimbursed against evidence.
All business travel must be agreed in advance by the officer responsible for the project
Sustainability aspects for travel
GIZ has undertaken an obligation to reduce greenhouse gas emissions (CO2 emissions) caused by travel. When preparing your tender, please incorporate options for reducing emissions, such as selecting the lowest-emission booking class (economy) and using means of transport, airlines and flight routes with a higher CO2 efficiency. For short distances, travel by train (second class) or e-mobility should be the preferred option.
CO2 emissions caused by air travel must be offset. GIZ specifies a budget for this, through which the carbon offsets can be settled against evidence.
There are many different providers in the market for emissions certificates, and they have different climate impact ambitions. The Development and Climate Alliance (German only) has published a list of standards (German only). GIZ recommends using the standards specified there.
Specification of inputs:
The following basic calculations for the contract for works are a reference value based on the acceptance criteria for each partial work/milestone specified in Chapter 2 (Tasks to be performed by the contractor).
Since the contract to be concluded is a contract for works, we would ask you to offer your services at a lump sum price.
In addition, the assessment of the financial bid is also based on the underlying daily rate. Please also provide the underlying daily rate. A breakdown of days is not required.
- Requirements on the format of the tender
The structure of the tender must correspond to the structure of the ToR. In particular, the detailed structure of the concept (Chapter 3) should be organised in accordance with the positively weighted criteria in the assessment grid (not with zero). The tender must be legible (font size 11 or larger) and clearly formulated. It must be drawn up in English.
The complete tender must not exceed 10 pages (excluding CVs). If one of the maximum page lengths is exceeded, the content appearing after the cut-off point will not be included in the assessment. External content (e.g. links to websites) will also not be considered.
The CVs of the personnel proposed in accordance with Chapter 4 of the ToRs must be submitted using the format specified in the terms and conditions for application. The CVs shall not exceed 4 pages each. They must clearly show the position and job the proposed person held in the reference project and for how long. The CVs can also be submitted in English.
As the contract to be concluded is a contract for works, please offer a fixed lump sum price that covers all relevant costs (fees, travel expenses etc.). The price bid will be evaluated on the basis of the specified lump sum price. In addition, please also provide the underlying daily rate. A breakdown of days is not required.
How to apply
Please request all tender documents via email from au_bidderquestions@giz.de by mentioning 83494198 Malawi on your subject email.
Tender documents include:
- Invitation letter
- Bidding conditions
- General Terms and Conditions of Contract (AVB local)
- Terms of Reference (ToR)
- Technical assessment grid
- Price Sheet
- Eligibility Self Declaration
- Specimen for association clause (if relevant)
- Extract from Act against Restraints on Competition (GWB)