Medicine Supply Systems Strengthening
Access to Medicines.
Henrik K.Nielsen
Technical Specialist
Essential Medicines Unit - Medicines and Nutrition Centre
UNICEF Supply Division, Copenhagen Denmark
WHO/UNICEF TECHNICAL BRIEFING SEMINAR, GENEVA
4 NOVEMBER 2010
Where do UNICEF SD supply medicines
• UNICEF country programmes
• Procurement Service Customers
UN agencies
NGO's
MOH
TOTAL PROCUREMENT (Pharmaceuticals)
2008
Pharmaceuticals
2009
2010*
$ 135.017.400 $ 175.651.300
$160.107.104
* As per mid October 2010
TOTAL PROCUREMENT, TOP 10
2008
1
2
2009
2010*
Zidovudine/Lamivudine/Nevirapine:300
/150/200/PAC 60
Stavudine/Lamivudine/Nevirapine:3
0/150/200/PAC-60
Efavirenz 600 mg /PAC 30
Stavudine/Lamuvidine/Nevirapine
30/150/200mg tabs/PAC-60 gb
Artemetheter/Lumefantrine
20mg/120mg tab/24/PAC-30
Artemeter/Lumefantrin: 20/120mg
6x4/PAC-720
Artemeter/Lumefantrine,
20/120mg tab,6x4/PAC-720
Zidovudine/Lamivudine/Nevirapine
300/150/200mg tabs/PAC-60 gb
Zidovudine/Lamivudine/Nevirapine
300+150+200mg tabs/PAC-60 gb
Efavirenz 600mg tabs/PAC-30
Stavudine+Lamuvidine+Nevirapine
30/150/200mg tabs/PAC-60 gb
3
4
Efavirenz 600mg tabs/PAC-30
5
Zinc 20mg tablets/PAC-100
Zidovudine /Lamivudine
300/150mg tabs/PAC-60
6
Iodized oil 200mg caps/PAC-1500
Oral reh.salts,new formula,1L s/CAR1000
Micronutrient,film-coated tabs/PAC1000
7
Sulfameth.+trimeth.400+80mg
tabs/PAC-500
Mebendazole 500mg tabs/PAC-100
Sulfameth.+trimeth.400+80mg
tabs/PAC-500
8
Micronutrient,film-coated
tabs/PAC-1000
Tenofovir 300mg tabs/PAC-30
gb
Amoxicillin 250mg caps/tabs/PAC1000
9
Mebendazole 500mg tabs/PAC100
Albendazole 400mg tabs/PAC-100
Zidovudine 300mg tabs/PAC-60
1
0
Artesunate
50mg+Amodiaquine153 cobl,tab/12+12/PAC-10
Disinfectants/antiseptics
Oral reh.salts,new formula,1L
s/CAR-1000
gb
Mebendazole 500mg tabs/PAC-100
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 experience
License to manufacture pharmaceuticals
Financial 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:
Product
Dosage form and strength
Quantity
CoA:
Satisfactory remaining shelf-life
Manufactured by the approved site
Random quality control in accordance with plan
Quality control of direct shipments
• Pre-delivery inspections
Third 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