Presentation - Verification of medicinal products in Europe · Author - Date - Event EMVO...
Transcript of Presentation - Verification of medicinal products in Europe · Author - Date - Event EMVO...
Author - Date - Event
Andreas M. WALTER
EMVO General Manager
Verification of Medicinal
Products in Europe
Author - Date - Event
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
Author - Date - Event
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
of 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
other 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
0
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
Author - Date - Event
Questions?