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UNICEF Medicines Supply Strengthening WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 30 UNICEF Medicines Supply Strengthening WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 30 October 2012 Technical Specialist Henrik K. Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division

UNICEF 2 UNICEF 2

About the Copenhagen warehouse • Over 20, 000 m 2, 36, 000 pallets • About the Copenhagen warehouse • Over 20, 000 m 2, 36, 000 pallets • Fully automated 3

Major commodity groups 2011 (millions of US$) 4 Major commodity groups 2011 (millions of US$) 4

Supplies then and now 5 Supplies then and now 5

Where UNICEF supplies are used by value/percentage 6 Where UNICEF supplies are used by value/percentage 6

Top supplier countries 2011 (millions of US$) 7 Top supplier countries 2011 (millions of US$) 7

Where we are Supply Division: Copenhagen, New York Supply hubs: Panama, Dubai, Shanghai Field Where we are Supply Division: Copenhagen, New York Supply hubs: Panama, Dubai, Shanghai Field warehouses by value of inventory, in US$’ 8

Where does UNICEF SD supply medicines • UNICEF country programmes • Procurement Services Customers Where does UNICEF SD supply medicines • UNICEF country programmes • Procurement Services Customers UN Agencies NGO’s MOH 9

UNICEF Quality system is based on • Division and Centre Procedures • Principles of UNICEF Quality system is based on • Division and Centre Procedures • Principles of WHO Model QA systems for Procurement, TRS 937 Annex is implemented 10

Pre-qualification - Pharmaceuticals • Manufacturers Review of submitted documentation ( Technical Questionnaire) Export experience Pre-qualification - Pharmaceuticals • Manufacturers Review of submitted documentation ( Technical Questionnaire) Export experience License to manufacture pharmaceuticals Financial status 11

Pre-qualification - Pharmaceuticals • Pharmaceutical Product: • Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Pre-qualification - Pharmaceuticals • Pharmaceutical Product: • Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNICEF SD 12

Pre-qualification - Pharmaceuticals • WHO Prequalification of suppliers of Vaccines, HIV/AIDS and malaria products Pre-qualification - Pharmaceuticals • WHO Prequalification of suppliers of Vaccines, HIV/AIDS and malaria products • Products must be pre-qualified by WHO and listed on the website • Suppliers to confirm to UNICEF that the products are identical to those assessed by WHO 13

Pre-qualification – Pharmaceuticals for none WHO prequalified products • • • • Complete Interagency Pre-qualification – Pharmaceuticals for none WHO prequalified products • • • • Complete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TS 937): Full International Non-proprietary Name (INN name) No brand or trade name GMP certificate of FPP Manufacturing site Marketing Authorisation in country of origin, and exporting countries if applicable Certificate of Pharmaceutical product (CPP) API, Reference to Pharmacopeias and CEP/DMF GMP certificate of the API Manufacturing site/Co. A of the API Specifications for the Finished Pharmaceutical Product (reference to Ph. Int, Ph. Eur, BP or USP where applicable) Stability reports of the Finished Pharmaceutical Product Language requirements: English and French unless other specified Sample for evaluation 14

GMP inspections by UNICEF SD • Principles of Quality System for GMP inspections in GMP inspections by UNICEF SD • 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 • 100 GMP inspections carried out 2007 -2012. 19 Companies failed • Detailed GMP inspection report forwarded to the company with request to respond within 1 month. • All manufacturers with contract are GMP inspected at regular interval – normally every 2 -5 years 15

Pre-qualification - Pharmaceuticals • Done in connection with the tender process • Supply Agreement Pre-qualification - Pharmaceuticals • Done in connection with the tender process • Supply Agreement with best offer • Practical all products are on the WHO Essential Medicines List 16

Products received in the warehouse are always inspected • Visual Inspection: Product Dosage form Products received in the warehouse are always inspected • Visual Inspection: Product Dosage form and strength Quantity Co. A: satisfactory remaining shelf-life Manufactured by the approved site Random quality control in accordance with plan 17

Quality control testing • Analysis performed on a random basis according to an annual Quality control testing • Analysis performed on a random basis according to an annual plan • Analysis performed by contract laboratory 18

Quality control of direct shipment • Pre-delivery inspections - Third party - UNICEF Country Quality control of direct shipment • Pre-delivery inspections - Third party - UNICEF Country Office • Review of packaging list and Certificate of Analysis • Random quality control testing in accordance with prior experience 19

Local procurement • All local procurement of pharmaceuticals requires approval from UNICEF SD • Local procurement • All local procurement of pharmaceuticals requires approval from UNICEF SD • Products from local manufacturers have been evaluated in countries like: • Bangladesh, India 20

Thank you www. unicef. org/supply hnielsen@unicef. org Thank you www. unicef. org/supply [email protected] org