Medicine Supply Systems Strengthening

Access to Medicines.

Henrik K.NielsenTechnical Specialist

Essential Medicines Unit - Medicines and Nutrition CentreUNICEF Supply Division, Copenhagen Denmark

WHO/UNICEF TECHNICAL BRIEFING SEMINAR, GENEVA4 NOVEMBER 2010

Where do UNICEF SD supply medicines

• UNICEF country programmes

• Procurement Service CustomersUN agenciesNGO'sMOH

TOTAL PROCUREMENT (Pharmaceuticals)

2008 2009 2010*

Pharmaceuticals $ 135.017.400 $ 175.651.300 $160.107.104

* As per mid October 2010

TOTAL PROCUREMENT, TOP 10 2008 2009 2010*1 Stavudine+Lamuvidine+Nevirapine

30/150/200mg tabs/PAC-60 gbZidovudine/Lamivudine/Nevirapine:300/150/200/PAC 60

Stavudine/Lamivudine/Nevirapine:30/150/200/PAC-60

2 Efavirenz 600 mg /PAC 30Stavudine/Lamuvidine/Nevirapine 30/150/200mg tabs/PAC-60 gb

Artemetheter/Lumefantrine20mg/120mg tab/24/PAC-30

3

Artemeter/Lumefantrin: 20/120mg6x4/PAC-720

Artemeter/Lumefantrine,20/120mg tab,6x4/PAC-720

Zidovudine/Lamivudine/Nevirapine300/150/200mg tabs/PAC-60 gb

4Zidovudine/Lamivudine/Nevirapine 300+150+200mg tabs/PAC-60 gb

Efavirenz 600mg tabs/PAC-30 Efavirenz 600mg tabs/PAC-30

5 Zinc 20mg tablets/PAC-100Zidovudine /Lamivudine 300/150mg tabs/PAC-60 gb Mebendazole 500mg tabs/PAC-100

6 Iodized oil 200mg caps/PAC-1500Oral reh.salts,new formula,1L s/CAR-1000

Micronutrient,film-coated tabs/PAC-1000

7Sulfameth.+trimeth.400+80mg tabs/PAC-500 Mebendazole 500mg tabs/PAC-100

Sulfameth.+trimeth.400+80mg tabs/PAC-500

8Micronutrient,film-coated tabs/PAC-1000

Tenofovir 300mg tabs/PAC-30 gb

Amoxicillin 250mg caps/tabs/PAC-1000

9Mebendazole 500mg tabs/PAC-100 Albendazole 400mg tabs/PAC-100 Zidovudine 300mg tabs/PAC-60

10

Artesunate 50mg+Amodiaquine153 co-bl,tab/12+12/PAC-10 Disinfectants/antiseptics

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 6 is implemented

• ISO 9000:2001

Manufacturers of Pharmaceuticals

• Manufacturers: Review of submitted documents (Technical Questionnaire)

  Export experienceLicense to manufacture pharmaceuticalsFinancial status

Pre-qualification –Pharmaceuticals

• Pharmaceutical Products Two scenarios:

1. WHO Prequalified Pharmaceuticals

2. Assessed in UNICEF SD

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 WHO website

 • Supplier has confirmed to UNICEF that products are

identical to those assessed by WHO/UNICEF

Pre-qualification of products for none WHO prequalified products

 • Interagency Product Questionnaire:•  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• Based on assessment: Conclusion: Acceptable/Not Acceptable

 

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

 • 89 GMP inspections carried out in 2006-2009. 30 % failed

• Detailed GMP inspection report forwarded to company (respond within 1 month)

• All manufacturers with contract are GMP inspected at regular intervals- normally every 2-5 years

Products received in the warehouse are always quality inspected

Visual inspection:ProductDosage form and strengthQuantity CoA:

Satisfactory remaining shelf-life Manufactured by the approved site

Random quality control in accordance with plan

Quality control of direct shipments

• Pre-delivery inspectionsThird party, Country Office

 • Review of packaging list and CoA • Random quality control testing in accordance with prior

experience

Local procurement/Production  

• All local procurement of pharmaceuticals requires approval from UNICEF SD

 • Products form local manufacturers has been evaluated

in countries like:

• Bangladesh, India, Ethiopia, Indonesia, Peru

Thank You