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IDENTIFICATION & AUTHENTICATION OF MEDICINES IN EUROPE: “OPPORTUNITIES AND CHALLENGES TO COMPLY WITH EU

LEGISLATION”

CHINA/EU PHARMACEUTICAL FORUM 2018 16TH APRIL 2018

BASEL, SWITZERLAND

Andreas Walter (General Manager)

AGENDA

2 EFPIA-CPIA WORKSHOP

16th April 2018

FMD/DR

EMVO/EMVS

Status Implementation

Achievements & Challenges


16th April 2018

4

16th April 2018

EFPIA-CPIA WORKSHOP

FMD LEGISLATION AND DELEGATED ACT

July 2011 Publication of FMD

2011

9 Feb 2019 Mandatory verification of all packs in scope

9 Feb 2016 Publication of

Delegated Regulation

36 Mon.

2019 2016 2017 2018

•  Connect approx. 2,291 companies to the EMVS •  Establish National Systems in 32 countries •  Connect many thousand Pharmacies and Wholesalers •  Serialise all affected pharmaceutical packs (10.5 bn)

THE DELEGATED REGULATION MANDATES RULES FOR ℞ MEDICINES VERIFICATION

5

Serialization by manufacturer

Risk based verification by Wholesalers

Verification and check-out at point of dispense

Safety features: Code (‘unique identifier’)

+

Tamper evidence

System set up and governed by manufacturers and marketing auth. holders in consultation with other stakeholders. Oversight by competent authorities

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

EFPIA-CPIA WORKSHOP

AGENDA


16th April 2018

FMD/DR

EMVO/EMVS



SYSTEM LANDSCAPE


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SYSTEM LANDSCAPE

8

OBP OBP

OBP: On-boarding Partner NMVS: National Medicines Verification System NMVO: National Medicines Verification Organisation

NMVO

EFPIA-CPIA WORKSHOP

EMVO MEMBERS


16th April 2018

10

ORGANISATIONAL CHART EMVO Board of Directors

President: Hugh Pullen (EFPIA) Vice-President: Sonia Ruiz Morán (PGEU) Treasurer: Richard Freudenberg (EAEPC)

Monika Derecque-Pois (GIRP) Adrian van den Hoven (Medicines for Europe)

Tel.Helpdesk+3726119044

EFPIA-CPIA WORKSHOP

16th April 2018

GeneralManagementAndreasWalter

Commercial&Partner

ManagementTobiasBeer

FannyTrenteseaux

InternIntern

EmmanouelaNikolakopoulou

MarkusGerigk

(externalconsultant)

JannikJäger(intern)

Intern

Opera4onsKoenVanGompel

AndréGeraldes

WillemTheunissen(externalconsultant)

JoãoPacheco

PaulMills

(externalconsultant)

OfficeManagementMarisaJimenez

Sanchez

Intern

QualityAssuranceStephan

Theunissen

AnneSeAragones

FIRSYT LINE SUPPORT: EMVO SERVICE CENTRE (Tallinn)

11EFPIA-CPIAWORKSHOP

16thApril2018

Tel.Helpdesk+3726119044

Agenda


16th April 2018

FMD/DR

EMVO/EMVS

StatusImplementa\on

Achievements&Challenges

STAKEHOLDER GOVERNANCE: NMVO

13

15

14

2 20

31

1 18

10

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

25 29

22

7

11

5

23

21

NMVO Incorporated (all stakeholders)

NMVO Incorporated (stakeholder missing)

No NMVO

Non EU Countries

EFPIA-CPIA WORKSHOP

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BLUEPRINT TENDENCY

14

15

14

2 20

31

1 18

10

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

25 29

22

7

11

5

23

21

Blueprint candidate

Small Country Blueprint

Blueprint open

Standalone system

Non EU Countries

EFPIA-CPIA WORKSHOP

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DR-COMPLIANCE 02/2019: VERY LATE COUNTRIES

15

Governance Technical

Align MoU Stat NMVO PM ProvC ProvS Contr B R

= Incomplete Stakeholder Participation

EFPIA-CPIA WORKSHOP

13 Hungary

18 Liechtenstein

21 Malta

24 Poland

Greece and Italy not heading for 2019

25 Portugal

Align = Stakeholder Alignment MoU = MoU signed Stat = NMVO Statutes signed NMVO = NMVO implemented

PM = Project Manager assigned ProvC = Provider Contacts established ProvS = Provider selected Contr = Provider Contract signed

31 Switzerland

32 U. Kingdom

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MAH ON-BOARDING


15

14

2 20

31

1 18

10

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

25 29

22

7

11

5

23

21

Above Target

Below Target

Actual Target 100%

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SIGNED PARTICIPATION AGREEMENT BY OBPS PER COUNTRY

17 16th April 2018

Additional PA signed by OBPs in non-european countries: 2 OBPs 2 OBPs

0 100 200 300 400 500 600

Austria Belgium Bulgaria Croatia Cyprus CZ Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland UK

EFPIA-CPIA WORKSHOP

1 OBP

15

15 1

23

19

6

1 3

13

10 1

15

STATUS ON-BOARDING


20 47

69 92

113

151 174

211

265

478 498

545

9 27 54

64 84 98

128 151

178

224 239

279

4 10 10 13

0

100

200

300

400

500

600

Earlier May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Janv-18 Feb-18 Mar-18

Nu

mb

er

Signed Participation Agreements Legitimacy check passed

OBPs connected to Hub V2 (PRD)

Target figure: 2291

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NMVS READINESS


15

14

2 20

31

1 18

10

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

25 29

22

7

11

5

23

21

Early Adopter

Main Stream

Late Follower

Not started

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END USER READINESS


15

14

2 20

31

1 18

10

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

25 29

22

7

11

5

23

21

Above Target

Below Target

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AGENDA


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FMD/DR

EMVO/EMVS



ü  EMVO incorporated & EU Hub upgraded 2.0 (but limited resources)

ü 29 NMVOs (>75%) founded, ü 30 countries choose Blueprint ü 656 OBPs in Portal, 545 PA signed,

13 in PRD. Scheduled: 1.900 end of Q4 2017

ü 21 CA signed ü Only Germany connected to EU

Hub (PRD)

22

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EFPIA-CPIA WORKSHOP

CHALLENGES & ACHIEVEMENTS ON EUROPEAN LEVEL

Ø  Set-up EMVO & EU Hub Ø  NMVO incorporated & NMVS

selected (provider contract signed) Ø  Connect approx. 2,291 On-boarding

Partners (OBPs) to the EU Hub

Ø  Connect 27 (+5) NMVS to the to the

EU Hub: Ø  Cooperation Agreement (CA)

signed Ø  NMVS assessments & technical

on-boarding Ø  On-boarding/certification of

connection providers

Challenges Achievements

CHALLENGES & ACHIEVEMENTS ON NATIONAL LEVEL: HOSPITALS


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Limited knowledge of FMD in

health (and social) care

Limited involvement of hospital

expertise in NMVOs

Limited cross-information between MS on issues and

solutions

Limited information

on on-boarding • Collecting of case

studies/ national pilots; • Gathering a consensus

on issues and solutions

Defining a strategy to get the involvement of hospital expertise in NMVOs

Defining a communication strategy (including NCAs!) to increase awareness in member states at all levels

Updating HOPE/EAHP mapping exercise with current situation including: •  Governance indicators •  Awareness indicators •  Technical indicators

NCAs/NMVOs TO ACT

ü  Slow progress and low feedback(despite EMVO circular)

ü No progress or feedback (despite

EMVO circular)

ü Constructive dialogue NCAs (WG II)/EMVO in order to harmonise access to data/reporting throughout Europe. Common position possible.

24

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EFPIA-CPIA WORKSHOP

CHALLENGES & ACHIEVEMENTS ON NATIONAL LEVEL: INVOLVEMENT NCAs

Ø NCAs in several countries not involved reg. operations (awareness raising of end users and national manufacturers/MAHs)

Ø Nearly no support of NCAs reg. hospital integration in almost all countries (ownership, budgeting, awareness, etc.)

Ø Access to data by NCAs: Extended reporting requested

Challenges Achievements

NCAs/EMVO/NMVOs TO ACT

CONCLUSION: EUROPE CAN BE READY, IF…..


16th April 2018

There is strong involvement, commitment and cooperation of all supply chain stakeholders on European and national level: It is a European, not only a national project!

NCAs play their role: Raising awareness, supporting the implementation process, hospitals, coding requirements, voluntary use of the safety features, regulatory pathway to implement the Safety Features, art work requirements, etc. Without support, the timely implementation could be at risk!

COM supports the implementation process and clarifies the legislation (awareness, Q&A, etc.)


16th April 2018

Tel. Helpdesk: +372 611 90 44 E-Mail: [email protected]

BACKUP


16th April 2018

o EMVO Website •  Process Description for Pharmaceutical

Companies & OBP Portal https://emvo-medicines.eu/pharmaceutical-companies/

•  Knowledge Database & Documents Overview https://emvo-medicines.eu/knowledge-database/

o Documentation •  On-boarding Checklist

https://youtu.be/SvmHYSEOBdI

•  Presentation, Guideline, Master Data Guide https://emvo-medicines.eu/knowledge-database/