Verification of Medicinal Products in Europe Andreas M. WALTER - - PowerPoint PPT Presentation

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Andreas M. WALTER EMVO General Manager

Verification of Medicinal Products in Europe

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EMVO stakeholders have a common vision of medicines verification

• Protect patients
• Secure the legal supply chain
• Be proactive as market partners
• Set up a stakeholder-governed

model that is

• Functioning
• Harmonised
• Cost-effective
• Inter-operable

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Delegated Regulation will mandate rules for medicines verification

Serialization by manufacturer + Verification at point of dispense Code (‘safety feature’) + Tamper evidence System set up and governed by stakeholders under supervision

• f authorities

Product #: 09876543210982 Batch: A1C2E3G4I5 Expiry: 140531 S/N: 12345AZRQF1234567890

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Pan-European Structure

National System Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor National System National System National System National System National System

European Hub

Required by Delegated Regulation

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EMVO members are allocated to a constituency

Membership open to

• ther stakeholder

associations

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Executive Summary Country Readiness

Early Adopter Main Stream Late Follower No Information Non EU Countries

15 14 2 2 31 1 1 8 10 16 24 6 27 13 28 4 3 26 19 17 8 12 30 9 32 25 29 22 7 11 5 23 2 1

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Questions?