The United Nations Secretariat invites Manufacturers of Maternal, Neonatal and Child Health Medicines, Products and Equipment to submit an Expression of Interest (EOI) for the following works:
The United Nations Secretariat is one of the six major organs of the United Nations, with the others being the General Assembly, the Security Council, the Economic and Social Council, the defunct Trusteeship Council, and the International Court of Justice. The secretariat is the UN's executive arm.
Applications are invited for:
Title: Expression of Interest (EOI) - Invitation to Manufacturers of Maternal, Neonatal and Child Health Medicines, Products and Equipment to submit an Expression of Interest (EOI) for the AfCFTA-anchored Pharma Initiative’s Local Production Evaluation by the UN Economic Commission for Africa
Description of Requirements
In line with Agenda 2063 and Sustainable Development Goas (SDGs), the main objective of the Pharma Initiative is to address socio-economic-related challenges facing African member countries relating to access to equitable, safe, and affordable medicines and the creation of fiscal space to the African Governments given the emerging trend of rising government debts. In addition, the Initiative leverages on the ratified AMA and the beginning of trading under the AfCFTA which brings on board a combined market of 1.3 billion people and gross domestic product (GDP) of $3.4 trillion, across all member states of the Africa Union.
The Pharma Initiative has a three-pronged approach; localized production; pooled procurement and a harmonized regulatory and quality framework focusing on maternal, neonatal and child health care (MNCH) products to address persistent challenges in MNCH burden, unmet needs, and access to reproductive health products across the select region. Further, the Initiative demonstrates the necessity and efficacy of investment in women's health as a key component of inclusive and sustainable economic development.
It is against this background and in line with the objectives stated above that ECA would like to invite manufacturers of MNCH product(s) to realize Africa’s vision leveraging on AfCFTA and AMA to fulfill the unmet needs of pilot member countries by increasing access to affordable and reliable supply of quality assured MNCH medicines.
Scope of Work
- Oxytocin injection 10 International Units (IU), 1ml
- Misoprostol 25 microgram tablet
- Misoprostol 200 microgram tablet (Misoprostol administered either orally, sublingually, or vaginally depending on the indication)
- Mifepristone 200 mg tablet (only to be used in combination with misoprostol)
- Mifepristone 200 mg tablet co-packaged with 4 tablets of misoprostol (Mifepristone (200mg) administered orally; misoprostol (4X200μg) administered either sublingually or vaginally)
- Zinc sulfate [Dispersible tablets 10mg, 20mg, and oral liquid 10mg per unit of dosage forms]. Other Zinc salts (i.e., gluconate, acetate, and citrate) containing 10mg or 20mg elemental Zinc are also invited for submission)
- Amoxicillin Dispersible tablets 125mg, 250mg and 500mg (scored)
- Amoxicillin Suspension 250mg
- Heat stable Carbetocin, injection 100 microgram/ml – in 1 ml
- Ergometrine Injection 500 micrograms/ml
- Labetalol Tablet 200 mg
- Levonorgestrel - Releasing IUDs
- Clomifene 50 mg Tablets
- Ethinylestradiol + Desogestrel Tablets (30 micrograms + 150 micrograms
- Ethinylestradiol + Levonorgestrel Tablets (30 micrograms + 150 micrograms
- Levonorgestrel Tablet 30 micrograms
- Levonorgestrel Tablet 30 micrograms
- Levonorgestrel Tablet 750 micrograms
- Norethisterone Tablet 350 micrograms
- Norgestrel Tablet 75 microgram
- Medroxyprogesterone Acetate Tablet 10 Mg
Injectable Hormonal Contraceptive:
- Medroxyprogesterone acetate Depot injection 150 mg/ml in 1ml vial
- Medroxyprogesterone acetate + Estradiol Cypionate injection 25mg + 5 mg
- Estradiol valerate + norethisterone enanthate injection 50 to 200 mg
- Two - rod Levonorgestrel-releasing implant, each rod containing 75mg Levonorgestrel (150 mg in total)
Application Closing Date
- Diaphragms (Female Condoms).
30th April, 2022.
Submission of Documents
All documents should be submitted to the email address: firstname.lastname@example.org
to express your interest to this EOI electronically.
Requirements for Submission of the Application
To apply for the expression of interest, the following documentation must be submitted in English Language.
Eligibility for submission
- A cover letter expressing interest in submitting the product application to ECA Technical Review Panel for evaluation.
- An acceptance letter from WHO pre-qualification program or accepted by a regulatory agency within the ICH member regions or accepted by a regulatory agency within the African harmonization regions (e.g., IGAD, EAC, SADC, ECOWAS etc.) confirming that the submission/ dossier for the product has been accepted for review and stating the approving agency reference number assigned to the specific product included in the EOI.
- An acceptance letter from WHO pre-qualification program or regulatory agency within the ICH member regions or regulatory agency within African harmonization region (e.g., IGAD, EAC, SADC, ECOWAS) confirming that the manufacturing site and production line where the product is manufactured comply with all aspects of current good manufacturing practice (cGMP).
- A completed pre-assessment application questionnaire (Form A) in response to each product with all the annexes stated in the pre-assessment application. To facilitate an assessment, a word format of the pre-assessment template should be included, and documents and their corresponding annex or attachment need to match their content in the pre-assessment questionnaire. Pre-assessment questions (Form A) should be completed for each product stated under section 4 above.
- In lieu of annexes, reference can be made to the dossier submitted and accepted as described under item number (2). In the event the annexes are updated this should be submitted with the note to the changes or updates.
To be considered eligible for application the following criteria must be fulfilled:
- The product dossier is accepted by WHO pre-qualification program or by regulatory agencies within the ICH member regions or regulatory agencies within the African harmonization regions (e.g., SIDS, IGAD, EAC, SADC) and the application reference number assigned to the specific product included in the terms of reference (TOR) is available; AND
- The manufacturing site is accepted or audited and received favorable opinion for acceptance from WHO pre-qualification program OR regulatory agencies within the ICH member countries OR regulatory agencies within the African harmonization countries (e.g., IGAD, EAC, SADC) confirming that the site and production line where the product is manufactured comply with all aspects of current good manufacturing practice (cGMP).
(PDF) for a detailed description of the EOI.
In case you have difficulties submitting your interest electronically, please contact email@example.com
directly for instructions.