AUDA- NEPAD

REQUEST FOR EXPRESSIONS OF INTEREST (REOI)

Procurement Title: Consultancy services for the review and development of regulatory and legal frameworks for ANMP (Tunisia) and AIRP (Côte d'Ivoire), aligned with WHO Global Benchmarking Tool requirements

Procurement Number: 066/AUDA/DHCID/AMRH/ICS/2025

Method: Individual Consultant Selection (ICS)

1. 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 on ensuring access to quality-assured, safe and effective medical products. The AMRH directly support’s 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 development and implementation of standards, guidelines, and processes for regulating medical products across the continent. Through the AMRH, the AUDA-NEPAD support’s 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) and the Republic of Côte d'Ivoire through the ‘Agence Ivoirienne de Reglementation Pharmaceutique’’ (AIRP) to review and update their 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).

2. Objectives of the Assignment
The objective is to support the Republic of Tunisia (ANMPS) and the Republic of Côte d'Ivoire(AIRP) to review their national legal and regulatory frameworks for medical products that fully align with the AU Model Law on Medical Products Regulation and the requirements of WHO GBT maturity level 3 (minimum), while taking into account the countries’ vision and strategic priorities for the pharmaceutical sector.

3. Main Responsibilities
In undertaking this exercise, the consultant will be expected to frequently consult and interact with the designated officer in AIRP. The scope of work to be undertaken will include the following:
i. Conduct a gap analysis of national legislation and regulations for medical products in the two countries.
ii. Draft or amend legal and regulatory texts (law, decree/ministerial order and regulations) covering core regulatory functions as per the WHO GBT.
iii. Facilitate stakeholder engagement with Tunisian and Ivorian authorities, regulatory bodies,
and other partners.
iv. Assist the legal department of the Ministries of Health in reviewing and validating the proposed
legal texts or regulations to ensure consistency with national frameworks and compliance with
international standards.
v. Incorporate feedback from national consultations into draft texts.
4. Deliverables
The consultant will be expected to submit the following deliverables:
i. Inception report detailing the process and methodology to be used for the assignment
ii. Gap analysis report on legal and regulatory frameworks pertaining to medical products
iii. First draft legal and regulatory texts
iv. Final draft legal and regulatory texts
v. Final Report
5. Qualifications and Experience Requirements
Applications may be submitted by a French-Speaking-Expert with the qualifications and experience stipulated below:
i. Master’s degree in medical regulatory science, pharmacy, medicine, chemistry, medical laboratory sciences, biomedical engineer, or any other related field.
ii. A minimum of 10 years work experience in implementation of regulatory reliance, networks and convergence, regulatory systems strengthening or harmonization initiatives.
iii. Extensive experience in Quality Management Systems or in assisting National Regulatory Authorities with the implementation of WHO GBT requirements.
iv. Experience working in a medical products regulatory body, Regional Medicines Regulatory
Harmonization programme or international harmonization initiatives will have an added
advantage.
v. Good knowledge on the African medical products regulation ecosystem, AMRH Initiative,
RECs MRH initiatives.
vi. Demonstrable exposure to international collaboration in the sector
6. Evaluation Criteria
A consultant will be selected in accordance with the individual consultant selection method of the
AU Procurement manual. For evaluation of the expressions of interest, the following criteria will be applied:

a. Qualifications - Education and Relevant Training (30 points);
b. Relevant Experience (45 points);
c. Knowledge and experience of the region & local conditions (10 points).)
d. Preference margin for AU member state citizens, youth and women (10 points)
e. Proficiency in 2nd AU language (English or Arabic preferred) (5 points)
f. The minimum qualifying score is 70 points
The detailed Terms of Reference (TOR) for the assignment can be found at the following website: (https://www.nepad.org/corporate-procurement#tenders).
7. Submission Requirements 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. Interested candidates are requested to submit the following documents for AUDA-NEPAD consideration:
i. Cover letter confirming compliance to eligibility.
ii. Signed declaration of undertaking (attached as Annex 1 below);
iii. Curriculum Vitae (CV); and
iv. Proof of stated qualifications in the form of the copies of the degrees obtained. Only Individual Consultants are eligible for this assignment and they must fulfil the following eligibility criteria:

i. Have no conflict of interest in relationship to performance of this assignment;
ii. 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.
iii. 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;
iv. 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;
v. Are not involved in corruption: offering, giving, receiving or soliciting, directly or indirectly, anything of value to influence improperly the actions of another party;
vi. 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;
vii. they have not been declared guilty of gross professional misconduct proven by any means which AUDA-NEPAD can justify;
viii. Comply with their national tax and social security laws

Expressions of interest must be delivered to the address below by email on or before 14th November 2025 at 14:30 hours (South African Time) with the following title in the subject lin of the email: “066/AUDA/DHCID/AMRH/ICS/2025, Consultancy services for the review and development of regulatory and legal frameworks for ANMP (Tunisia) and AIRP (Côte d'Ivoire), aligned with WHO Global Benchmarking Tool requirements”

The Chairperson, Internal Procurement Committee (IPC)
African Union Development Agency (AUDA-NEPAD)
230, 15th Road, P. O. Box 218 Midrand,
1685 Johannesburg, South Africa

Email: [email protected] ; and copy to [email protected]

Attention of: Procurement Division