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

UNICEF HQ Organizational Groupings Executive Director Programme Group Programmes Policy & Planning Supply Research Management Finance Human Resources ITD Audit & Evaluation Ext. Relations & Resource Mobil. Resource Mobilisation Commun ication Emergency Ops Executive Board Sec. NatComs & Greeting cards Regional Offices Country Offices HQ in Copenhagen Oversees UNICEF’s supply chain work Approx. 900 supply & logistics staff globally

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 3

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

WHERE ARE SUPPLIES USED? 5 Regions receiving supplies 2010

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

Total Procurement (Pharmaceuticals) * Pharmaceuticals$ $ $ * As per mid October 2011

TOTAL PROCUREMENT, TOP (mid Oct 2011) 1 Stavudine+Lamuvidine+Nevirae pin30/150/200mg tabs/PAC-60 gb Zidovudine/Lamivudine/Nevirapine: 300/150/200 mg tabs/PAC 60 Stavudine/Lamivudine/Nevirapine:30/150/200 mg tabs/PAC-60 2 Stavudine/Lamuvidine/Nevirapine 30/150/200mg tabs/PAC-60 gb Artemeter/Lumefantrine, 20/120mg tabs,6x4/PAC-30Artemetheter/Lumefantrine 20mg/120mg tab/24/PAC-30 3 Artemeter/Lumefantrine, 20/120mg tabs,6x4/PAC-720 Zidovudine/Lamivudine/Nevirapine 300/150/200mg tabs/PAC-60 Zidovudine/Lamivudine/Nevirapine 300/150/200mg tabs/PAC-60 gb 4 Efavirenz 600mg tabs/PAC-30 Efavirenz 600mg tabs/PAC-30 5 Zidovudine /Lamivudine 300/150mg tabs/PAC-60 gb Lamivudine/Nevirapine/Stavudine 150/200/30mg tabs/PAC-60 Mebendazole 500mg tabs/PAC Oral reh.salts,new formula, 1L s/CAR-1000Mebendazole 500mg tabs/PAC-100 Micronutrient,film-coated tabs/PAC Mebendazole 500mg tabs/PAC-100 Micronutrient,film-coated tabs/PAC-1000Sulfameth.+trimeth mg tabs/PAC Micronutrient,film-coated tabs/PAC Zidovudine 300mg tabs/PAC-60 Amoxicillin 250mg tabs/PAC Albendazole 400mg tabs/PAC-100 Lamivudine/Tenofovir DF 300/300 mg tabs/PAC 30 Zidovudine 300mg tabs/PAC Disinfectants/antiseptics Sulfameth.+trimeth mg tabs/PAC- 500 Oral reh.salts,new formula,1L s/CAR-1000

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 9

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

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

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 12

Pre-qualification – Pharmaceuticals for 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 13

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 GMP inspections carried out in 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 14

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

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 16

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 17

18 Thank you