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

5

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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