Terms of Reference
UNICEF Supply Division is seeking a Consultant to perform technical evaluations of locally procured pharmaceutical products in Ethiopia
Objectives of the consultancy:
Provide recommendations to UNICEF on suitability to procure locally manufactured essential medicines in Ethiopia: 1. To offer technical support to pre-selected local manufacturers of medicines on how to submit technical documentation required by UNICEF for assessment (Technical Questionnaire and Interagency Pharmaceutical Product Questionnaire (IPPQ)). 2. To review all submitted technical questionnaires and product dossiers (IPPQ and annexes) for completeness and if information is missing to provide feedback to the manufacturers. Upon receipt of satisfactory dossiers and product samples, to technically assess these for conformity. 3. Based on the outcome of assessment, to prepare a recommendation report to Essential Medicines Technical Specialist with the purpose to identify products that meet the specified quality standards. 4. To conduct technical evaluations on any other pharmaceutical product on the product list of the Ethiopia medicines kit as needed.
Background and basis for the consultancy
UNICEF procurement of pharmaceutical products is centralised in UNICEF Supply Division in Copenhagen. The oversight of quality assurance of UNICEF procured medicines is undertaken by a team of technical specialists based in Copenhagen. UNICEF procures Essential Medicines as identified in the current WHO Essential Medicines List to support specific UNICEF programmes in various countries and as well as for various global Emergency needs. In addition, UNICEF procures medicines on behalf of other development partners and various ministries via UNICEF procurement services. Over the years, UNICEF SD has supported UNICEF Ethiopia country office to procure a range of essential medicines for their primary healthcare kit. The content of the medicines kit can vary from time to time and the current kit contains the following medicines; 1. Benzoic acid 6% + Salicylic acid 3% ointment (tubes of 40g) 2. Chloramphenicol powder for injection, 1g vials 3. Tetracycline eye ointment 1% 4. Promethazine 25mg tablets 5. Paracetamol 100mg tablets 6. Chlorhexidine solution 5% concentration – 100ml bottle 7. ORS 8. Benzyl benzoate 25% lotion – 1000ml bottle 9. Magnesium trisilicate compound tablets 10. Paracetamol 500mg tablets
1 | P a g e 11. Doxycycline 100mg tablets 12. Amoxicillin 250mg dispersible tablets 13. Sodium lactate compound injection – 1000ml (with giving sets) 14. Sodium chloride injection 0.9% 500ml (with giving sets) 15. Zinc 20mg dispersible tablets 16. Iron + folic acid 60+0.4mg tablets 17. Ciprofloxacin 500mg tablets 18. Mebendazole 100mg chewable tablets 19. Metronidazol powder for oral suspension 200mg/5ml bottles 20. Adrenaline injection 1mg/ml 1ml ampoules 21. Metronidazole 250mg tablets 22. Cotrimoxazole 480 mg tablets 23. Ibuprofen 400mg tablets 24. Amoxicillin 250mg tablets 25. Contrimoxazole 240mg/5ml oral suspension
In the past, due to UNICEF QA/QC standards used in procurement, UNICEF SD has supplied all the medicines in the Ethiopia medicines kit from manufacturers based outside Ethiopia. However, in order to support high quality standards of pharmaceutical GMP in local markets in Africa, UNICEF SD would like to increase its supplier base of pharmaceutical manufacturers in Africa. A number of local manufacturers of pharmaceuticals in Ethiopia have been found to operate at levels of GMP that are at or close to those required by UNICEF, and this has created an opportunity to explore the local market for possible local procurement of some of the medicines contained in the Ethiopia medicines kit.
The consultancy is primarily to assist technical specialist based in UNICEF Copenhagen to technically evaluate bids for local tender.
A more in-depth briefing will be provided.
Terms of the consultancy
The consultancy is expected to work from home with travel to both UNICEF Supply Division office, Copenhagen, Denmark and Addis Ababa, Ethiopia. The provision of service should occur over a five week period and will include a desk review of product dossiers as well as face to face meetings with manufacturers in Ethiopia and UNICEF staff in Copenhagen and Addis Ababa.
The final assessment report should be written and include recommendations on the suitability of procurement based on product specifications and other criteria.
The coordinator in Supply Division for the consultancy is Henrik Nielsen, Technical Specialist; Medicines & Nutrition Centre.
2 | P a g e The final report will be confidential and under the ownership of UNICEF.
Timing
September – November 2014
Experience
The consultant should have an advanced university degree in pharmacy with over 8 years of professional experience in technical evaluation of pharmaceutical dossiers, development of pharmaceutical specifications, regulatory and/or quality assurance/controls of essential medicines. In addition, the consultant should have experience in data analysis, coordination and management of large amounts of data as well as extensive knowledge of UN and WHO procurement of pharmaceuticals.
The consultant will need to provide references, upon request.
The consultant will need to disclose any current or prior employment with suppliers, including in an advisory role. In case of a conflict of interest with UNICEF’s work, this may be a disqualifying factor.
Submission Details All interested consultants should send an application packet including the following: a. A completed Expression of Interest form, including the professional fee/rate, per person day; (Attachment A) b. Updated CV/Resume, and P11; c. Names and contact details of three work references.
The application packet should be transmitted via email to [email protected] by 22nd November, 2014, 11:59 pm CET. Email Subject: MNC-Ethiopia Consultancy Application. Late submissions, incomplete packets, or submissions with an incorrect email subject heading may not be considered.
UNICEF considers best value for money as a criteria for evaluating potential candidates. As a general principle, the fees payable to a consultant or individual contractor follow the “best value for money” principle, i.e., achieving the desired outcome at the lowest possible fee. Additional DSA and travel expenses will be provided as applicable to the project.
3 | P a g e ATTACHMENT A Expression of Interest Form
CONSULTANCY Quality Assurance Quality Control UNICEF Supply Division
Please fill-in page 1 of the form in its entirety and submit it to us electronically.
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