1 UNICEF Technical Briefing Seminar on Essential Medicines Poli day 1 November 2011 nical Specialist Henrik K.Nielsen, Medicines and Nutrition Ce CEF Supply Division ICEF Medicines Supply Strengthening
Feb 11, 2016
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines PoliciesTuesday 1 November 2011Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division
UNICEF Medicines Supply Strengthening
UNICEF HQ Organizational GroupingsExecutive Director
Programme Group Management Ext. Relations & Resource Mobil.
Regional Offices
Programmes
Policy & Planning
Supply
Research
Finance
Human Resources
ITD
Audit & Evaluation
ResourceMobilisation
Communication
EmergencyOps
Executive Board Sec.
NatComs &Greeting cards
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
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Major commodity groups 2010
Total Procurement 2010: $1.955 billion87% of procurement is for essential supplies for children
WHERE ARE SUPPLIES USED?
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Regions receiving supplies 2010
Where does UNICEF SD supply medicines
• UNICEF country programmes
• Procurement Service Customers UN agencies NGO’s MOH
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Total Procurement (Pharmaceuticals)
2009 2010 2011*Pharmaceuticals $ 175.651.300 $ 203.285.201 $ 149.975.324.
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* As per mid October 2011
TOTAL PROCUREMENT, TOP 10 2009 2010 2011(mid Oct 2011)
1Stavudine+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
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Stavudine/Lamuvidine/Nevirapine 30/150/200mg tabs/PAC-60 gb
Artemeter/Lumefantrine,20/120mg tabs,6x4/PAC-30 Artemetheter/Lumefantrine
20mg/120mg tab/24/PAC-30
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Artemeter/Lumefantrine,20/120mg tabs,6x4/PAC-720
Zidovudine/Lamivudine/Nevirapine300/150/200mg tabs/PAC-60
Zidovudine/Lamivudine/Nevirapine300/150/200mg tabs/PAC-60 gb
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Efavirenz 600mg tabs/PAC-30
Efavirenz 600mg tabs/PAC-30 Efavirenz 600mg tabs/PAC-30
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Zidovudine /Lamivudine 300/150mg tabs/PAC-60 gb
Lamivudine/Nevirapine/Stavudine150/200/30mg tabs/PAC-60
Mebendazole 500mg tabs/PAC-100
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Oral reh.salts,new formula,1L s/CAR-1000 Mebendazole 500mg tabs/PAC-100
Micronutrient,film-coated tabs/PAC-1000
7Mebendazole 500mg tabs/PAC-100
Micronutrient,film-coated tabs/PAC-1000 Sulfameth.+trimeth.400+80mg tabs/PAC-500
8Micronutrient,film-coated tabs/PAC-1000
Zidovudine 300mg tabs/PAC-60 Amoxicillin 250mg tabs/PAC-1000
9Albendazole 400mg tabs/PAC-100 Lamivudine/Tenofovir DF 300/300 mg
tabs/PAC 30Zidovudine 300mg tabs/PAC-60
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Disinfectants/antiseptics Sulfameth.+trimeth.400+80mg 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
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Pre-qualification - Pharmaceuticals
• Manufacturers• Review of submitted documentation (Technical Questionnaire)• Export experience• License to manufacture pharmaceuticals• Financial status
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Pre-qualification - Pharmaceuticals
• Pharmaceutical Products
• Two scenarios:
1. WHO Prequalified Pharmaceuticals
2. Assessed in UNCEF SD
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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
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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
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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 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
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Pre-qualification – Pharmaceuticals
• Done in connection with Tender process• Supply Agreement with best offer• Practical all products are on WHO Essential
Medicines List
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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
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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
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