AUDA-NEPAD

REQUEST FOR EXPRESSIONS OF INTEREST (REOI) FOR INDIVIDUAL CONSULTANTS
Title: Consultancy services to assist the Agence Nationale du Médicament et des Produits de
Santé’ ANMP (Tunisia) in developing a Reliance Framework and strengthening the National
Regulatory System function in line with WHO GBT requirements
PROCUREMENT NUMBER: 059/AUDA/DHCID/AMRH/ICS/2025
Method: Individual Consultants Selection (ICS) - Individuals Only

2.0 OBJECTIVE OF THE ASSIGNMENT
The AUDA-NEPAD seeks to engage the services of a consultant to support the ANMPS to
develop a Reliance Framework and strengthen the National Regulatory System in line with
WHO GBT Requirements
3.0 SCOPE/MAIN RESPONSIBILITIES OF THE ASSIGNMENT
The Consultant shall deliver on the following tasks:
➢ Conduct a comprehensive desk review of existing regulatory reliance pathways
implemented by ANMPS across all regulatory functions for medicines, vaccines and
medical devices, including diagnostics, in accordance with GRelP.
➢ Work with the AMRH initiative in the process of localizing the continental reliance
framework to ANMPS.
➢ Develop a National Reliance Framework for all regulatory functions that will promote a
more efficient approach to the regulation of medical products as per WHO Global
Benchmarking Tool (GBT), plus for medicines, vaccines and medical devices, including
in vitro diagnostics, with practical guides, illustrative examples of reliance approaches
and their implementation.
➢ Work closely with the WHO GBT focal point within ANMPS to meet the requirements
related to the national regulatory system.

1.0 BACKGROUND
The African Union Development Agency (AUDA-NEPAD) is the technical body of the African Union
whose mandate is to coordinate and execute priority regional and continental projects to promote regional
integration towards the accelerated realization of Agenda 2063 and strengthen the capacity of Member
States and regional bodies, including Regional Economic Communities (RECs).
The African Medicines Regulatory Harmonisation (AMRH) Initiative was launched in 2009 to support
African Union’s efforts in ensuring access to quality-assured, safe and effective medical products.
The AMRH directly supports the African Union’s efforts of promoting local manufacturing of medical
products as outlined in the Pharmaceutical Manufacturing Plan for Africa (PMPA) and Platform for
Harmonized African Health Products Manufacturing (PHAHM). The Initiative works with National
Regulatory Authorities (NRAs) to support the development and implementation of standards, guidelines
and processes for regulating medical products across the continent.
Through the AMRH, the AUDA-NEPAD supports Member States of the AU to adopt up-to-date laws and
regulations as a foundation of a robust national regulatory system for medical products and harmonised
regulatory systems across the continent. In this context, AUDA-NEPAD is supporting the Republic of
Tunisia through the ‘Agence Nationale du Médicament et des Produits de Santé’ (ANMPS) to review and
update its national regulatory systems for medical products to comply with the AU Model Law on medical
products regulation (Model Law) and WHO's Global Benchmarking Tool (GBT).

➢ Review the recommendations from the pre-benchmarking assessment related to the
function of the National Regulatory System.
➢ Assist in identifying the required Guidelines and relevant texts to be domesticated in
Tunisia.
➢ Facilitate stakeholder consultations to validate the Reliance Framework and other texts
developed to meet the recommendations for the National Regulatory System function.
4.0 AUDA-NEPAD now invites eligible individual consultants (“Consultants”) to indicate their
interest in providing the Services. Interested Consultants should provide information
demonstrating that they have the required qualifications and relevant experience to perform
the Services.
5.0 QUALIFICATIONS, EXPERIENCE AND COMPETENCIES
Qualifications
• Master’s degree in Medical Products Regulatory Sciences, Pharmacy, Medicine,
Chemistry, Medical Laboratory Sciences, Biomedical Engineering, or any other relevant
field from a recognized institution.
Experience
• A minimum of 10 years of work experience in the implementation of regulatory reliance,
networks and convergence, regulatory systems strengthening or harmonization
initiatives.
• Extensive experience in Quality Management Systems or in assisting National
Regulatory Authorities with the implementation of WHO GBT requirements.
• Prior experience working within a medical products regulatory authority, the Regional
Medicines Regulatory Harmonization Programme, or other international harmonization
initiatives shall be considered an added advantage.
• Comprehensive knowledge of the African medical products regulatory ecosystem,
including the African Medicines Regulatory Harmonization (AMRH) Initiative and
Regional Economic Communities (RECs) MRH programmes.
• Demonstrated experience in international collaboration and engagement with global
regulatory or health institutions.
6.0 SHORTLISTING CRITERIA
For evaluation of the expressions of interest, the following criteria will be applied:
a. Qualifications - Education and Relevant Training (30 points);
b. Experience related to the Assignment (50 points);
c. Knowledge and experience of the region & local conditions (10 points).)
d. Preference margin for AU member state citizens, youths and women (10 points)
e. The minimum qualifying score is 70 points
A Consultant will be selected in accordance with the Individual Consultant Selection (ICS)
method set out in the 2024 AU Procurement Manual. The Terms of Reference (TORs),
Request for Expression of Interest (REOI), and Statement of Declaration of Undertaking
are available for download via the advertisement link.
7.0 SUBMISSION REQUIREMENTS
Interested candidates are requested to submit the following documents for AUDA-NEPAD
consideration:
I. Cover letter;
II. Signed declaration of undertaking (downloadable from AUDA-NEPAD website and
attached as Annex 1 below);
III. Curriculum Vitae (CV), indicating projects previously done by the Consultant; and
IV. Proof of stated Qualifications in the form of copies of the Degrees obtained.

8.0 REPORTING AND TIMELINES:
During the assignment, the consultant shall submit all reports under the assignment to the
Principal Programme Officer or her designate within the AUDA-NEPAD. The reports will be
approved by ANMPS prior to submission to the AUDA-NEPAD.
The assignment will be completed within a total of 60 Man-days over 6 calendar months from
the date of the signing of the contract.
9.0 Only Individual Consultants are eligible for this assignment if they fulfil the following
eligibility criteria:
a) Have no conflict of interest in relation to the performance of this assignment;
b) Are not subject to, and not controlled by any entity or individual that is subject to, a
temporary suspension or a debarment imposed by the African Union Commission, World
Bank or any other multilateral development bank and being listed on the website
http://www.worldbank.org/debarr or, respectively, on the relevant list of any other
multilateral development bank. Further, are not ineligible pursuant to a decision of the
United Nations Security Council;
c) Have not been convicted by a final judgement or a final administrative decision or subject
to financial sanctions by the United Nations or Country for involvement in a criminal
organisation, money laundering, terrorist-related offences, child labour or trafficking in
human beings; this criterion of exclusion is also applicable to legal Persons, whose
majority of shares are held or factually controlled by natural or legal Persons which
themselves are subject to such convictions or sanctions;
d) Are not being bankrupt, wound up or ceasing our activities, having our activities
administered by courts, having entered receivership, reorganisation or being in any
analogous situation;
e) Are not involved in corruption: offering, giving, receiving or soliciting, directly or indirectly,
anything of value to influence improperly the actions of another party;
f) They have not been the subject of a judgment which has the force of res judicata for
fraud, corruption, involvement in a criminal organization or any other illegal activity
detrimental to the AUDA-NEPAD financial interests;
g) they have not been declared guilty of gross professional misconduct proven by any
means which AUDA-NEPAD can justify;
h) Comply with their national tax and social security laws
Interested consultants may obtain further information from the address listed below. All
Expressions of Interest should be sent electronically to the email listed below.
10.0 Expressions of interest must be delivered to the address below by email on or before
November 14, 2025, at 14:00 hours (South African Time). All EOI’s must be marked
“059/AUDA/DHCID/AMRH/ICS/2025 – ‘’ Consultancy services to assist the Agence
Nationale du Médicament et des Produits de Santé’ ANMP (Tunisia) in developing a
Reliance Framework and strengthening the National Regulatory System function in line
with WHO GBT requirements’’ in the subject line of the email.
11.0 Privacy Policy: AUDA-NEPAD Procurement office collects and uses your personal
information for “Procurement Process” when you intend to compete and deliver any
service or goods for the organization either individually or as a firm based on your
consent. Your personal data is our highest security and kept for a period strictly
necessary for the purpose set out. This privacy notice supplements the AUDA-NEPAD
standard privacy notice and should be read in conjunction with the same available on
AUDA-NEPAD website.

The Chairperson Internal Procurement Committee (IPC)

AUDA-NEPAD

230, 15th Road, P. O. Box 218 Midrand,
1685 Johannesburg, South Africa

Email: [email protected] & copy [email protected]

Attention of: Head of Procurement Division