Post on 25-Mar-2021
STATUS OF IMPLEMENTATION the FMD -
VIEWPOINT FROM EMVO
Roundtable Falsified Medicines Directive -Are We Ready?
Improving patient safety with theFMD in the hospital pharmacy
European Parliament, 19th February 2019Andreas M. WALTER
WHO WE ARE
o European Medicines Verification Organisation(EMVO)
o Unique collaboration between supply chain stakeholders comprised of EU medicine manufacturers, parallel distributors, wholesalers, pharmacists, hospitals and hospital pharmacists
o Mandate from stakeholders to:
• Set up the Hub
• Connect countries to the Hub
• Facilitate onboarding of industry/manufacturers to the EU Hub
o EMVO’s driving mission is patient safety. The safety of patients across Europe is at the centre of our work
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HOW THE SYSTEM WORKS
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STATUS ON-BOARDING
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Data collected onFebruary 4th 2019
80127
154191
217 233263
304345
593635
664
726
794
927952
9771015
1062 1073 1093 1112
2047
6992 113
151174
211265
478 498545
601
668
804827 841
878
935 944980
1025
9 2754 64 84 98
128151
178224 239
279
373
477
539
625667
713
786
847870
1000
18
86 107 126165
222273
344389
464
548
665
751
857
410 10 13 21
4580
104
193215
293
387
499
614
2664
125178
335
0
200
400
600
800
1000
1200
Nu
mb
er
OBPs On the Portal Signed Participation Agreements
Legitimacy Check Passed OBPs Connected to the Hub (IQE)
OBPs Connected to the Hub (PRD) OBPs Connected to the Hub (PRD) which uploaded PMD
4
UPLOADED PRODUCT MASTER DATA
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Data collected onFebruary 4th, 2019
22697
47066
66427
128989
0
20000
40000
60000
80000
100000
120000
140000
oct-18 nov-18 déc-18 janv-19
Product Master Data in the System
Product Master Data in the System
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2 countries
Longer
Implementation
Period
28 countries
Connected in PRD
2 countries
Not Started Technical On-Boarding
Full functionality with coming releases
NMVO ON-BOARDING - PROGRESS OVERVIEW
In 27 Countries, first
packs have been
verified by End-Users
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EMVS
o European-wide IT project within EU & EEA
o Operational issues and teething problems on European/national level to be expected
o Rapid crisis management in order to maintain trust in the system’s added value and to avoid supply chain disruptions
o Data quality/availability a cornerstone for the success
o User compliance and enforcement by NCA are critical (case by case)
o Alert handling in a flexible and smooth way
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CONCLUSION: CALL FOR “STABILIZATION PERIOD” WHILE MAINTAINING PATIENT SAFETY
Period to ensure a controlled application of the NMVS and an uninterrupted medicines supply (to be negotiated with NCA), i.e.
o Flexible alert handling (in cooperation with NCA);
o Enforcement and inspections only on a case by case basis;
o Increase of EMVS stability/performance, i.e. • Well performing EU Hub and NMVS (data quantity & data quality of utmost
importance)• Well performing IT systems of On-Boarding Partners (OBPs)• Well performing IT systems of End-Users
o Completion of serialization, OBP & end-user onboarding;
o Staged implementation of NCA reporting;
o Improve crisis management and maintain trust in the system’s added value
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ADDITIONAL INFORMATIONo EMVO Website
• Article 23 Implementation https://emvo-medicines.eu/newdoc/european-commission-article-23-implementation/
• Knowledge Database & Documents Overview https://emvo-medicines.eu/knowledge-database/
o Documentation• Q&As V13.0
https://emvo-medicines.eu/new/wp-content/uploads/qa_safetyfeature_en_V13.pdf
• OBP On-boarding Guideline https://emvo-medicines.eu/new/wp-content/uploads/EMVO_0077_OBP-On-boarding_Guideline-4.pdf
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Questions?
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