1. UNICEF Medicines Supply Strengthening WHO Technical Briefing Seminar on Essential Medicines and Health Products Tuesday 29 October 2013 Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division

2. 2 UNICEF.

3. About the Copenhagen warehouse Entirely controlled by computer 9300 m2 150m Long x 62m Wide x 24m High 36,000 pallet locations 8 robot cranes Each crane operating 4 racks Each crane operating 4500 pallets

4. Supply in the UNICEF structure

5. Major commodity groups 2012: $2.468 billion in supplies and services Approximately $1.13 billion funded via Procurement Services (procurement on behalf of governments and other partners)

6. Supplier countries

7. Where we are 855 staff 135 nationalities 163 offices 99 countries Panama Dubai Shanghai

8. Where does UNICEF SD supply medicines UNICEF country programmes Procurement Services Customers UN Agencies NGO’s MOH

9. UNICEF Quality system is based on Division and Centre Procedures Principles of WHO Model QA systems for Procurement, TRS 937 Annex is implemented

10. Pre-qualification - Pharmaceuticals Manufacturers Review of submitted documentation ( Technical Questionnaire) Export experience License to manufacture pharmaceuticals Financial status

11. Pre-qualification - Pharmaceuticals Pharmaceutical Product: Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNICEF SD

12. Pre-qualification - Pharmaceuticals WHO Prequalification of suppliers of Vaccines, HIV/AIDS and malaria products Products must be pre-qualified by WHO and listed on the website Suppliers to confirm to UNICEF that the products are identical to those assessed by WHO

13. Pre-qualification – Pharmaceuticals non- WHO prequalified products Complete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TRS 937): Full International Non-proprietary Name (INN name) No brand or trade name GMP certificate of FPP Manufacturing site Marketing Authorisation in country of origin, and exporting countries if applicable Certificate of Pharmaceutical product (CPP) API, Reference to Pharmacopeias and CEP/DMF GMP certificate of the API Manufacturing site/CoA of the API Specifications for the Finished Pharmaceutical Product (reference to Ph.Int, Ph.Eur, BP or USP where applicable) Stability reports of the Finished Pharmaceutical Product Language requirements: English and French unless other specified Sample for evaluation

14. GMP inspections – by UNICEF SD Decision based on the regulatory environment In country of origin and prior experience of UNICEF GMP inspection by UNICEF or a representative selected by UNICEF Contracts Manufacture only accepted if subcontractor also is approved by UNICEF WHO GMP guidelines used as reference 100 GMP inspections carried out in 2007-2012. 19 companies failed Detailed GMP inspection report forwarded to company with request to respond within 1 month

15. GMP inspections – Continued All manufacturers with contract are GMP inspected at regular intervals – normally every 2- 5 year Local authority invited to participate Joint inspections with WHO, ICRC, MSF UNICEF is a partner to the Pharmaceutical Inspections Cooperation Scheme (PIC-S) UNICEF use available information to waive UNICEF inspections

16. Pre-qualification - Pharmaceuticals Done in connection with the tender process Supply Agreement with best offer Practical all products are on the WHO Essential Medicines List

17. Products received in the warehouse are - always inspected Visual Inspection: Product Dosage form and strength Quantity CoA: satisfactory remaining shelf-life Manufactured by the approved site Random quality control in accordance with plan

18. Quality control - testing Analysis performed on a random basis according to an annual plan Analysis performed by contract laboratory

19. Quality control of direct shipment Pre-delivery inspections - Third party - UNICEF Country Office Review of packaging list and Certificate of Analysis Random quality control testing in accordance with prior experience

20. Local procurement All local procurement of pharmaceuticals requires approval from UNICEF SD Products from local manufacturers have been evaluated in countries like: Bangladesh, India

21. Thank you