WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 1 November 2011

1. UNICEF Medicines Supply Strengthening WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 1 November 2011 Technical Specialist HenrikK.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division

2. UNICEF HQ Organizational Groupings • HQ in Copenhagen • Oversees UNICEF’s supply chain work • Approx. 900 supply & logistics staff globally

3. THE ROLE OF SUPPLY DIVISION • Oversees UNICEF’s global procurement and logistics operation • Procures supplies on behalf of UNICEF and Procurement Services partners • Ensures that high quality, good value supplies reach children and their families quickly

4. Major commodity groups 2010 Total Procurement 2010: $1.955 billion 87% of procurement is for essential supplies for children

5. WHERE ARE SUPPLIES USED? Regions receiving supplies 2010

6. Where does UNICEF SD supply medicines • UNICEF country programmes • Procurement Service Customers UN agencies NGO’s MOH

7. Total Procurement (Pharmaceuticals) * As per mid October 2011

8. TOTAL PROCUREMENT, TOP 10

9. UNICEF Quality system is based on • Division and Centre Procedures • Principles of WHO Model QA system for Procurement TRS 937 Annex is implemented • ISO 9000:2001

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

11. Pre-qualification - Pharmaceuticals • Pharmaceutical Products • Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNCEF SD

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

13. Pre-qualification – Pharmaceuticalsfor none WHO prequalified products • Interagency Product Questionnaire: (Product Questionnaire as in Model QA system WHO TRS 937) •  Full International Non-proprietary Name • (INN name)/No brand or trade name • GMP Certificate • Manufacturing license in country of origin • Regulatory situation in country of origin and in other countries • Certificate of Pharmaceutical Product (CPP) • API , References to Pharmacopeias and CEP/DMF. CoA and GMP certificate. • Specifications for Finished Pharmaceutical Products (reference: Ph. Int, /Ph.Eur/BP or USP) and specific monographs where applicable • CoA’s of 3 production batches • Stability studies of the Finished Pharmaceutical Product • Language requirements: English and French unless other specified • Expiry date format: dd/mm/yyyy • Sample including PIL and device like measuring device. • Based on assessment: Conclusion: Acceptable/Not Acceptable

14. GMP inspections by UNICEF • Principles of Quality System for GMP inspections in accordance with PIC-s Quality System requirement for GMP inspectorates is followed. WHO GMP Guidelines used as reference • 103 GMPinspections carried out in 2006-2010. 28 companies failed (27%) • Detailed GMP inspection report forwarded to company with request to respond within 1 month • All manufacturers with contract are GMP inspected at regular intervals-normally every 2-5 years

15. Pre-qualification – Pharmaceuticals • Done in connection with Tender process • Supply Agreement with best offer • Practical all products are on WHO Essential Medicines List

16. 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

17. Local procurement/Production • All local procurement of pharmaceuticals requires approval from UNICEF SD • Products from local manufacturers have been evaluated in countries like: • Bangladesh, India, Ethiopia, Indonesia, Peru

18. Thank you www.unicef.org/supply hnielsen@unicef.org