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

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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 Groupings

Executive Director

Programme Group ManagementExt. 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 billion

87% 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 60Stavudine/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/Nevirapine

300/150/200mg tabs/PAC-60

Zidovudine/Lamivudine/Nevirapine

300/150/200mg 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/Stavudine

150/200/30mg 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 30

Zidovudine 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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Thank you www.unicef.org/[email protected]